19 Del. Admin. Code § 1342-G-6.0

Current through Register Vol. 27, No. 12, June 1, 2024

Section 1342-G-6.0 - Therapeutic Procedures - Non-Operative

Treating providers, as well as employers and insurers are highly encouraged to reference the General Guidelines Principles (Section 2.0) prior to initiation of any therapeutic procedure. Before initiation of any therapeutic procedure, the authorized treating provider, employer and insurer must consider these important issues in the care of the injured worker.

First, patients undergoing therapeutic procedure(s) should be released or returned to modified, restricted duty during their rehabilitation at the earliest appropriate time. Refer to Return-to-Work in this section for detailed information.

Second, cessation and/or review of treatment modalities should be undertaken when no further significant subjective or objective improvement in the patient's condition is noted. If patients are not responding within the recommended duration periods, alternative treatment interventions, further diagnostic studies or consultations should be pursued.

Third, providers should provide and document education to the patient. No treatment plan is complete without addressing issues of individual and/or group patient education as a means of facilitating self-management of symptoms.

Last, formal psychological or psychosocial evaluation should be performed on patients not making expected progress within 6 to 12 weeks following injury and whose subjective symptoms do not correlate with objective signs and tests. Earlier psychological intervention may be necessary and will be dependent on the treating physician's assessment of psychological or psychosocial issues that may interfere with the patient's recovery.

In cases where a patient is unable to attend an outpatient center, home therapy may be necessary. Home therapy may include active and passive therapeutic procedures as well as other modalities to assist in alleviating pain, swelling, and abnormal muscle tone. Home therapy is usually of short duration and continues until the patient is able to tolerate coming to an outpatient center.

The following procedures are listed in alphabetical order.

6.1ACUPUNCTURE is an accepted and widely used procedure for the relief of pain and inflammation in the lower extremity. There is some scientific evidence to support its use for hip and knee osteoarthritis. The exact mode of action is only partially understood. Western medicine studies suggest that acupuncture stimulates the nervous system at the level of the brain, promotes deep relaxation, and affects the release of neurotransmitters. Acupuncture is commonly used as an alternative or in addition to traditional Western pharmaceuticals. While it is commonly used when pain medication is reduced or not tolerated, it may be used as an adjunct to physical rehabilitation and/or surgical intervention to hasten the return of functional activity. Acupuncture should be performed by MD, DC, DO with appropriate training; or a licensed acupuncturist.

6.1.1Acupuncture: is the insertion and removal of filiform needles to stimulate acupoints (acupuncture points). Needles may be inserted, manipulated and retained for a period of time. Acupuncture can be used to reduce pain, reduce inflammation, increase blood flow, increase range-of-motion, decrease the side effect of medication-induced nausea, promote relaxation in an anxious patient, and reduce muscle spasm.

6.1.1.1 Indications include joint pain, joint stiffness, soft tissue pain and inflammation, paresthesia, post-surgical pain relief, muscle spasm, and scar tissue pain.

6.1.2Acupuncture with Electrical Stimulation: is the use of electrical current (micro-amperage or milli-amperage) on the needles at the acupuncture site. It is used to increase effectiveness of the needles by continuous stimulation of the acupoint. Physiological effects (depending on location and settings) can include endorphin release for pain relief, reduction of inflammation, increased blood circulation, analgesia through interruption of pain stimulus, and muscle relaxation.

6.1.2.1 It is indicated to treat chronic pain conditions, radiating pain along a nerve pathway, muscle spasm, inflammation, scar tissue pain, and pain located in multiple sites.

6.1.3Total Time Frames for Acupuncture and Acupuncture with Electrical Stimulation: Time frames are not meant to be applied to each of the above sections separately. The time frames are to be applied to all acupuncture treatments regardless of the type or combination of therapies being provided.

6.1.3.1 Time to Produce Effect: 3 to 6 treatments.

6.1.3.2 Frequency: 1 to 3 times per week.

6.1.3.3 Optimum Duration: 1 to 2 months.

6.1.3.4 Maximum Duration: 14 treatments.

6.1.3.5 Any of the above acupuncture treatments may extend longer if objective functional gains can be documented or when symptomatic benefits facilitate progression in the patient's treatment program. Treatment beyond 14 treatments must be documented with respect to need and ability to facilitate positive symptomatic or functional gains. Such care should be re-evaluated and documented with each series of treatments.

6.1.4Other Acupuncture Modalities: Acupuncture treatment is based on individual patient needs and therefore treatment may include a combination of procedures to enhance treatment effect. Other procedures may include the use of heat, soft tissue manipulation/massage, and exercise. Refer to Active Therapy (Therapeutic Exercise) and Passive Therapy sections (Massage and Superficial Heat and Cold Therapy) for a description of these adjunctive acupuncture modalities and time frames.

6.2BIOFEEDBACK is a form of behavioral medicine that helps patients learn self-awareness and self-regulation skills for the purpose of gaining greater control of their physiology, such as muscle activity, brain waves, and measures of autonomic nervous system activity. Electronic instrumentation is used to monitor the targeted physiology and then displayed or fed back to the patient visually, auditorially, or tactilely, with coaching by a biofeedback specialist. Biofeedback is provided by clinicians certified in biofeedback and/or who have documented specialized education, advanced training, or direct or supervised experience qualifying them to provide the specialized treatment needed (e.g., surface EMG, EEG, or other). 6.2.1 Treatment is individualized to the patient's work-related diagnosis and needs. Home practice of skills is required for mastery and may be facilitated by the use of home training tapes. The ultimate goal in biofeedback treatment is normalizing the physiology to the pre-injury status to the extent possible and involves transfer of learned skills to the workplace and daily life. Candidates for biofeedback therapy or training must be motivated to learn and practice biofeedback and self-regulation techniques. 6.2.2 Indications for biofeedback include individuals who are suffering from musculoskeletal injury in which muscle dysfunction or other physiological indicators of excessive or prolonged stress response affects and/or delays recovery. Other applications include training to improve self-management of emotional stress/pain responses such as anxiety, depression, anger, sleep disturbance, and other central and autonomic nervous system imbalances. Biofeedback is often utilized along with other treatment modalities.

6.2.3 Time to Produce Effect: 3 to 4 sessions.

6.2.4 Frequency: 1 to 2 times per week.

6.2.5 Optimum Duration: 5 to 6 sessions.

6.2.6 Maximum Duration: 10 to 12 sessions. Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate functional gains.

6.3BONE-GROWTH STIMULATORS

6.3.1Electrical: Pre-clinical and experimental literature has shown a stimulatory effect of externally applied electrical fields on the proliferation and calcification of osteoblasts and periosteal cells. All of the studies on bone growth stimulators, however, have some methodological deficiencies and high-quality literature of electrical bone growth stimulation is lacking for lower extremity injuries.

6.3.1.1 These acceptable nonsurgical techniques include Capacitive Coupling (CC), which places skin electrodes on opposite sides of the bone being treated and Pulsed Electromagnetic Field (PEMF) which uses a current-carrying coil which induces a secondary electrical field in bone.

6.3.2Low-intensity Pulsed Ultrasound: There is some evidence that low-intensity pulsed ultrasound, applied by the patient at home and administered as initial treatment of the fracture, reduces the time required for cortical bridging in tibial fractures. Non-union and delayed unions were not included in these clinical trials. Possible indications for Low-Intensity Pulsed Ultrasound are non-unions or fractures that are expected to require longer healing time.

6.3.2.1 FDA approved bone-growth stimulators of any type may be appropriate for patients with non-union after initial fracture care or for patients with acute fractures or osteotomies who are at high risk for delayed union or non-union. Patients at high risk include, but are not limited to, smokers, diabetics, and those on chemotherapeutic agents or other long-term medication affecting bone growth.

6.4EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)

6.4.1 Extracorporeal shock wave therapy (ESWT) delivers an externally applied acoustic pulse to the plantar fascia. It has been hypothesized that ESWT causes microtrauma to the fascia, inducing a repair process involving the formation of new blood vessels and delivery of nutrients to the affected area. High energy ESWT is delivered in one session and may be painful requiring some form of anesthesia. It is not generally recommended for the treatment of plantar heel pain due to increased cost when it is performed with conscious sedation. It may also be performed with local blocks. Low energy ESWT does not require anesthetics. It is given in a series of treatments, generally three sessions.

6.4.2 There is conflicting evidence concerning low energy ESWT for plantar heel pain. Focused ESWT concentrates the acoustic pulse on a single point in the heel, while radial ESWT distributes the pulse along the entire plantar fascia. Focused low energy ESWT has not been shown to produce clinically important reductions in plantar heel pain. There is some evidence that radial ESWT may reduce plantar pain more effectively than placebo, but a successful response may occur in only 60% of patients. There is some evidence supporting high-energy ESWT.

6.4.3 Low energy radial or high energy ESWT with local blocks are accepted treatments. It should only be used on patients who have had plantar pain for 4 months or more; have tried NSAIDs, ice, stretching exercises, shoe inserts; and have significant functional deficits. These patients should meet the indications for surgery found in Section 5.0, heel spurs, plantar fascia pain. Tarsal tunnel syndrome should be ruled out. Peripheral vascular disease, lower extremity neuropathy and diabetes are all relative contraindications. Diagnostic testing may be needed to rule out these conditions. 6.4.4 Time to Effect: 2 sessions. 6.4.5 Optimum Duration: 3 sessions one week or more apart. 6.4.6 Maximum Duration: Treatment may be continued for up to 5 total sessions if functional improvement has been demonstrated after three treatment sessions. Functional improvement is preferably demonstrated using direct testing or functional scales validated in clinical research settings.

6.5INJECTIONS-THERAPEUTIC

6.5.1General Description: Therapeutic injection procedures may play a significant role in the treatment of patients with lower extremity pain or pathology. Therapeutic injections involve the delivery of anesthetic and/or anti-inflammatory medications to the painful structure. Therapeutic injections have many potential benefits. Ideally, a therapeutic injection will: (a) reduce inflammation in a specific target area; (b) relieve secondary muscle spasm; (c) allow a break from pain; and (d) support therapy directed to functional recovery. Diagnostic and therapeutic injections should be used early and selectively to establish a diagnosis and support rehabilitation. If injections are overused or used outside the context of a monitored rehabilitation program, they may be of significantly less value. . All injections may be performed with or without ultrasound guidance. Ultrasound guided interventional procedures provides the ability to image soft tissues in real time and can improve safety and accuracy of needle placement. The use of ultrasound guided procedures will be at the discretion of the health care provider.

6.5.2General Indications: Diagnostic injections are procedures which may be used to identify pain generators or pathology. For additional specific clinical indications, see Section 5.0, Specific Lower Extremity Injury Diagnosis, Testing and Treatment.

6.5.3Special Considerations: The use of injections has become progressively sophisticated. Each procedure considered has an inherent risk, and risk versus benefit should be evaluated when considering injection therapy. In addition, all injections must include sterile technique.

6.5.4General Contraindications: General contraindications include local or systemic infection, bleeding disorders, allergy to medications used, and patient refusal. Specific contraindications may apply to individual injections.

6.5.5Joint Injections: are generally accepted, well-established procedures that can be performed as analgesic or anti-inflammatory procedures.

6.5.5.1 Time to Produce Effect: Immediate with local anesthesia, or within 3 days if no anesthesia.

6.5.5.2 Optimum Duration: Usually one to two injections is adequate.

6.5.5.3 Maximum Duration: Not more than three to four times annually.

6.5.5.4 Steroid injections should be used cautiously in diabetic patients. Diabetic patients should be reminded to check their blood-glucose level at least twice daily for two weeks post-injections. Injections may be performed with or without ultrasound guidance. Ultrasound guided interventional procedure provides the ability to image soft tissues in real time and can improve safety and accuracy of needle placement. The use of ultrasound guided procedures will be at the discretion of the health care provider.

6.5.6Soft Tissue Injections: include bursa and tendon insertions. Injections under significant pressure should be avoided as the needle may be penetrating the tendon. Injection into the tendon can cause tendon degeneration, tendon breakdown, or rupture. Injections should be minimized for patients younger than 30 years of age.

6.5.6.1 When performing tendon insertion injections, the risk of tendon rupture should be discussed with the patient and the need for restricted duty emphasized.

6.5.6.2 Time to Produce Effect: Immediate with local anesthesia, or within 3 days if no anesthesia.

6.5.6.3 Optimum Duration: Usually one to two injections is adequate.

6.5.6.4 Maximum Duration: Not more than three to four times annually.

6.5.6.5 Steroid injections should be used cautiously in diabetic patients. Diabetic patients should be reminded to check their blood-glucose level at least twice daily for two weeks post-injections. Injections may be performed with or without ultrasound guidance. Ultrasound guided interventional procedure provides the ability to image soft tissues in real time and can improve safety and accuracy of needle placement. The use of ultrasound guided procedures will be at the discretion of the health care provider.

6.5.7Trigger Point Injections: although generally accepted, have only rare indications in the treatment of lower extremity disorders. Therefore, their routine use is not recommended in the treatment of lower extremity injuries.

6.5.7.1 Description: Trigger point treatment can consist of dry needling or injection of local anesthetic with or without corticosteroid into highly localized, extremely sensitive bands of skeletal muscle fibers that produce local and referred pain when activated. Medication is injected in a four-quadrant manner in the area of maximum tenderness. Injection efficacy can be enhanced if injections are immediately followed by myofascial therapeutic interventions, such as vapo-coolant spray and stretch, ischemic pressure massage (myotherapy), specific soft tissue mobilization and physical modalities. There is conflicting evidence regarding the benefit of trigger point injections. A truly blinded study comparing dry needle treatment of trigger points is not feasible. There is no evidence that injection of medications improves the results of trigger-point injections. Needling alone may account for some of the therapeutic response.

6.5.7.2 There is no indication for conscious sedation for patients receiving trigger point injections. The patient must be alert to help identify the site of the injection.

6.5.7.3 Indications:

6.5.7.3.1 Trigger point injections may be used to relieve myofascial pain and facilitate active therapy and stretching of the affected areas. They are to be used as an adjunctive treatment in combination with other treatment modalities such as functional restoration programs. Trigger point injections should be utilized primarily for the purpose of facilitating functional progress. Patients should continue with a therapeutic exercise program as tolerated throughout the time period they are undergoing intensive myofascial interventions. Myofascial pain is often associated with other underlying structural problems, and any abnormalities need to be ruled out prior to injection.

6.5.7.3.2 Trigger point injections are indicated in those patients where well circumscribed trigger points have been consistently observed, demonstrating a local twitch response, characteristic radiation of pain pattern and local autonomic reaction, such as persistent hyperemia following palpation. Generally, these injections are not necessary unless consistently observed trigger points are not responding to specific, noninvasive, myofascial interventions within approximately a 6 week time frame.

6.5.7.4 Complications: Potential but rare complications of trigger point injections include infection, anaphylaxis, neurapraxia, and neuropathy. If corticosteroids are injected in addition to local anesthetic, there is a risk of developing local myopathy. Severe pain on injection suggests the possibility of an intraneural injection, and the needle should be immediately repositioned.

6.5.7.5 Time to Produce Effect: Local anesthetic 30 minutes; no anesthesia 24 to 48 hours.

6.5.7.6 Frequency: Weekly, suggest no more than 4 injection sites per session per week to avoid significant post-injection soreness.

6.5.7.7 Optimum Duration: 4 Weeks.

6.5.7.8 Maximum Duration: 8 weeks. Occasional patients may require 2 to 4 repetitions of trigger point injection series over a 1 to 2 year period.

6.5.8Viscosupplementation/Intracapsular Acid Salts: is an accepted form of treatment for osteoarthritis or degenerative changes in the knee joint. There is good evidence that intra-articular hyaluronic acid injections have only a small effect on knee pain and function. Therefore, the patient and treating physician should identify functional goals and the likelihood of achieving improved ability to perform activities of daily living or work activities with injections versus other treatments. The patient should agree to comply with the treatment plan including home exercise. These injections may be considered an alternative in patients who have failed non-operative treatment and surgery is not an option, particularly, if non-steroidal anti-inflammatory drug treatment is contraindicated or has been unsuccessful. Viscosupplementation is not recommended for patients with severe osteoarthritis who are surgical candidates. Its efficacy beyond 6 months is not well-established. There is no evidence that one product significantly outperforms another, prior authorization is required to approve product choice and for repeat series of injections.

6.5.8.1 One injection of 6 ml of Hylan G-F 20 may be effective and is an option for knee injections.

6.5.8.2 Viscosupplementation is not recommended for ankle osteoarthritis due to the small effect size documented in knee conditions and the lack of evidence supporting its use in the ankle. Viscosupplementation is not recommended for hip arthritis given the probable superiority of corticosteroid injections. In rare cases a patient with significant hip osteoarthritis who does not qualify for surgical intervention may try viscosupplementation. It should be done with ultrasound or fluoroscopic guidance and will not necessarily require a series of three injections. The patient may choose to have repeat injections when the first injection was successful.

6.5.8.3 Time to Produce Effect: After 1 series or one injection as discussed above, there must be a functional gain lasting three months to justify repeat injections.

6.5.8.4 Frequency: One injection or 1 series (3 to 5 injections generally spaced 1 week apart).

6.5.8.5 Optimum/Maximum Duration: Varies. Efficacy beyond 6 months is not well-established.

6.5.9Prototherapy: (also known as sclerotherapy) consists of peri-articular injections of hypertonic dextrose with or without phenol with the goal of inducing an inflammatory response that will recruit cytokine growth factors involved in the proliferation of connective tissue. Advocates of prolotherapy propose that these injections will alleviate complaints related to joint laxity by promoting the growth of connective tissue and stabilizing the involved joint.

6.5.9.1 Laboratory studies may lend some biological plausibility to claims of connective tissue growth, but high quality published clinical studies are lacking. The dependence of the therapeutic effect on the inflammatory response is poorly defined, raising concerns about the use of conventional anti-inflammatory drugs when proliferant injections are given. The evidence in support of prolotherapy is insufficient and therefore, its use is not recommended in lower extremity injuries.

6.6JOBSITE ALTERATION

6.6.1 Early evaluation and training of body mechanics are essential for every injured worker. Risk factors to be addressed include: repetitive work, lifting, and forces that have an impact on the lower extremity. In some cases, this requires a jobsite evaluation. There is no single factor or combination of factors that is proven to prevent or ameliorate lower extremity pain, but a combination of ergonomic and psychosocial factors are generally considered to be important. Physical factors that may be considered include use of force, repetitive work, squatting, climbing, kneeling, crouching, crawling, prolonged standing, walking a distance or on uneven surfaces, jumping, running, awkward positions requiring use of force, and lower extremity vibration. Psychosocial factors to be considered include pacing, degree of control over job duties, perception of job stress, and supervisory support.

6.6.2 The job analysis and modification should include input from the employee, employer, and a medical professional familiar with work place evaluation. An ergonomist may also provide useful information. The employee must be observed performing all job functions in order for the jobsite analysis to be valid. Periodic follow-up is recommended to evaluate effectiveness of the intervention and need for additional ergonomic changes.

6.6.3 Interventions: should consider engineering controls (e.g., mechanizing the task, changing the tool used, or adjusting the jobsite), or administrative controls (e.g., adjusting the time an individual performs the task).

6.7MEDICATIONS AND MEDICAL MANAGEMENT

6.7.1 Use of medications will vary widely due to the spectrum of injuries from simple strains to complicated fractures. A thorough medication history, including use of alternative and over-the-counter medications, should be performed at the time of the initial visit and updated periodically. Treatment for pain control is initially accomplished with acetaminophen and/or NSAIDs. The patient should be educated regarding the interaction with prescription and over-the-counter medications as well as the contents of over-the-counter herbal products.

6.7.2 Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are useful in the treatment of injuries associated with degenerative joint disease and/or inflammation. These same medications can be used for pain control.

6.7.3 Topical agents can be beneficial for pain management in lower extremity injuries. This includes topical capsaicin, nonsteroidals, as well as topical iontphoretics/phonophoretics, such as steroid creams and lidocaine.

6.7.4 Glucosamine and chondroitin are sold in the United States as dietary supplements. Their dosage, manufacture, and purity are not regulated by the Food and Drug Administration. For moderate to severe knee osteoarthritis, there is good evidence for the effectiveness of a pharmaceutical grade combination of 500 mg glucosamine hydrochloride and 400 mg chondroitin sulfate three times per day. Effectiveness for mild disease is unknown. Recent literature suggests that chondroitin sulfate in a dose of 800 mg once daily may reduce the rate of joint degradation as demonstrated by joint space loss on serial x-rays.

6.7.5 For mild-to-moderate osteoarthritis confined to the hip, there is good evidence that a pharmaceutical-grade glucosamine sulfate is unlikely to produce a clinically significant improvement in pain and joint function.

6.7.6 When osteoarthritis is identified as a contributing factor to a work-related injury, pharmaceutical grade glucosamine and chondroitin may be tried. Long-term coverage for these medications would fall under Workers' Compensation only when the arthritic condition is primarily related to the work injury. 6.7.7 S-adenosyl methionine (SAM-e), like glucosamine and chondroitin, is sold as a dietary supplement in the United States, with a similar lack of standard preparations of dose and manufacture. There is some evidence that a pharmaceutical-grade SAM-e is as effective as celecoxib in improving pain and function in knee osteoarthritis, but its onset of action is slower. Studies using liquid chromatography have shown that it may lose its potency after several weeks of storage. In addition, SAM-e has multiple additional systemic effects. It is not currently recommended due to lack of availability of pharmaceutical quality, systemic effects, and loss of potency with storage.

6.7.8 The following medications and medical management items are listed in alphabetical order.

6.7.8.1Acetaminophen is an effective analgesic with antipyretic but not anti-inflammatory activity. Acetaminophen is generally well tolerated, causes little or no gastrointestinal irritation and is not associated with ulcer formation. Acetaminophen has been associated with liver toxicity in overdose situations or in chronic alcohol use. Patients may not realize that many over-the-counter preparations may contain acetaminophen. The total daily dose of acetaminophen is recommended not to exceed 4 grams per 24-hour period, from all sources, including narcotic-acetaminophen combination preparations.

6.7.8.1.1 Optimal Duration: 7 to 10 days.

6.7.8.1.2 Maximum Duration: Chronic use as indicated on a case-by-case basis. Use of this substance long-term for 3 days per week or greater may be associated with rebound pain upon cessation.

6.7.8.2Bisphosphonates may be used for those qualifying under osteoporosis guidelines. Long-term use for the purpose of increasing prosthetic fixation is not recommended as long-term improvement in fixation is not expected. See Section 7, h., Osteoporosis Management Section below.

6.7.8.3Deep Venous Thrombosis Prophylaxis is a complex issue involving many variables such as individual patient characteristics, the type of surgery, anesthesia used and agent(s) used for prophylaxis. Final decisions regarding prophylaxis will depend on the surgeon's clinical judgment. The following are provided as generally accepted concepts regarding prophylaxis at the time of writing of these guidelines.

6.7.8.3.1 All patients undergoing lower extremity surgery or prolonged lower extremity immobilization should be evaluated for elevated risk for DVT and should receive education on prevention. Possible symptoms should be discussed. Patients at higher risk than the normal population include, but are not limited to, those with known hypercoagulable states and those with previous pulmonary embolism or DVT. Those considered at higher risk for bleeding, which may alter thromboprophylaxis protocols, include patients with a history of a bleeding disorder, recent gastrointestinal bleed, or hemorrhagic stroke.

6.7.8.3.2 There is no evidence to support mandatory prophylaxis for all patients who are immobilized or undergo lower extremity procedures, outside of hip or knee arthroplasties or hip fracture repair.

6.7.8.3.3 Hip and knee arthroplasties and hip fracture repair are standard risk factors requiring thromboprophylaxis. Commonly used agents are low molecular weight heparin, low dose un-fractionated heparin (LDUH), synthetic pentasaccaride fondaparinux, or warfarin. If aspirin is used, it should be accompanied by aggressive mechanical prophylaxis.

6.7.8.3.4 All patients should be mobilized as soon as possible after surgery. Mechanical prophylaxis such as pneumatic devices that are thigh calf, calf only, or foot pumps may be considered immediately post-operatively and/or until the patient is discharged home. Thigh length or knee high graduated compression stockings are used for most patients. With prolonged prophylaxis, lab tests must be drawn regularly. These may be accomplished with home health care or outpatient laboratories when appropriate.

6.7.8.4Minor Tranquilizer/Muscle Relaxants are appropriate for muscle spasm, mild pain and sleep disorders. When prescribing these agents, physicians must seriously consider side effects of drowsiness or dizziness and the fact that benzodiazepines may be habit-forming.

6.7.8.4.1 Optimal Duration: 1 week.

6.7.8.4.2 Maximum Duration: 4 weeks.

6.7.8.5Narcotics should be primarily reserved for the treatment of severe lower extremity pain. There are circumstances where prolonged use of narcotics is justified based upon specific diagnosis, and in these cases, it should be documented and justified. In mild-to-moderate cases of lower extremity pain, narcotic medication should be used cautiously on a case-by-case basis. Adverse effects include respiratory depression, the development of physical and psychological dependence, and impaired alertness.

6.7.8.5.1 Narcotic medications should be prescribed with strict time, quantity, and duration guidelines, and with definitive cessation parameters. Pain is subjective in nature and should be evaluated using a pain scale and assessment of function to rate effectiveness of the narcotic prescribed. The physician should refer to the chronic pain guidelines, when appropriate.

6.7.8.5.2 Optimal Duration: 1 week

6.7.8.5.3 Maximum Duration: 4 weeks.

6.7.8.5.4 Use beyond 4 weeks is acceptable in appropriate cases. Chronic use may be appropriate in selected individual cases.

6.7.8.6Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are useful for pain and inflammation. In mild cases, they may be the only drugs required for analgesia. There are several classes of NSAIDs, and the response of the individual injured worker to a specific medication is unpredictable. For this reason, a range of NSAIDs may be tried in each case with the most effective preparation being continued. Patients should be closely monitored for adverse reactions. The US Food and Drug Administration advise that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Administration of proton pump inhibitors, histamine 2 blockers, or prostaglandin analog misoprostol along with these NSAIDs may reduce the risk of duodenal and gastric ulceration but do not impact possible cardiovascular complications. Due to the cross-reactivity between aspirin and NSAIDs, NSAIDs should not be used in aspirin-sensitive patients, and should be used with caution in all asthma patients. NSAIDs are associated with abnormal renal function, including renal failure, as well as, abnormal liver function. Certain NSAIDs may have interactions with various other medications. Individuals may have adverse events not listed above.Intervals for metabolic screening are dependent upon the patient's age, general health status and should be within parameters listed for each specific medication. Complete Blood Count (CBC) andliver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.

6.7.8.6.1 NSAIDs may be used for pain management after joint replacement. They have also been used to reduce heterotopic ossification after arthroplasty. NSAIDs do reduce the radiographically documented heterotopic ossification in this setting, but there is some evidence that they do not improve functional outcomes and they may increase the risk of bleeding events in the post-operative period. Their routine use for prevention of heterotopic bone formation is not recommended.

6.7.8.6.2 Non -selective Nonsteroidal Anti-Inflammatory Drugs:

6.7.8.6.2.1 Includes NSAIDs and acetylsalicylic acid (aspirin). Serious GI toxicity, such as bleeding, perforation, and ulceration can occur at any time, with or without warning symptoms in patients treated with traditional NSAIDs. Physicians should inform patients about the signs and/or symptoms of serious gastrointestinal toxicity and what steps to take if they occur. Anaphylactoid reactions may occur in patients taking NSAIDs. NSAIDs may interfere with platelet function. Fluid retention and edema have been observed in some patients taking NSAIDs.

6.7.8.6.2.2 Optimal Duration: 1 week.

6.7.8.6.2.3 Maximum Duration: 1 year. Chronic use is appropriate in individual cases. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

6.7.8.6.3 Selective Cyclo-oxygenase-2 (COX-2) Inhibitors:

6.7.8.6.3.1 COX-2 inhibitors are more recent NSAIDs and differ in adverse side effect profiles from the traditional NSAIDs. The major advantages of selective COX-2 inhibitors over traditional NSAIDs are that they have less gastrointestinal toxicity and no platelet effects. COX-2 inhibitors can worsen renal function in patients with renal insufficiency, thus renal function may need monitoring.

6.7.8.6.3.2 COX-2 inhibitors should not be first-line for low risk patients who will be using a NSAID short-term but are indicated in select patients for whom traditional NSAIDs are not tolerated. Serious upper GI adverse events can occur even in asymptomatic patients. Patients at high risk for GI bleed include those who use alcohol, smoke, are older than 65, take corticosteroids or anti-coagulants, or have a longer duration of therapy. Celecoxib is contraindicated in sulfonamide allergic patients.

6.7.8.6.3.3 Optimal Duration: 7 to 10 days.

6.7.8.6.3.4 Maximum Duration: Chronic use is appropriate in individual cases. Use of these substances long-term (3 days per week or greater) is associated with rebound pain upon cessation.

6.7.8.7Oral Steroids have limited use but are accepted in cases requiring potent anti-inflammatory drug effect in carefully selected patients. A one-week regime of steroids may be considered in the treatment of patients who have arthritic flare-ups with significant inflammation of the joint. The physician must be fully aware of potential contraindications for the use of all steroids such as hypertension, diabetes, glaucoma, peptic ulcer disease, etc., which should be discussed with the patient.

6.7.8.7.1 Optimal Duration: 3 to 7 days.

6.7.8.7.2 Maximum Duration: 7 days.

6.7.8.8Osteoporosis Management:

6.7.8.8.1 All patients with conditions which require bone healing, especially those over 50, should be encouraged to ingest at least 1200 mg of Calcium and 800 IU of Vitamin D per day. There is some evidence that, for women in the older age group (58 to 88) with low hip bone density, greater callus forms for those who adhere to these recommendations than those who do not. Although the clinical implications of this are not known, there is greater non-union in this age group and thus, coverage for these medications during the fracture healing time period is recommended. At this time there is no evidence that bisphosphonates increase acute fracture healing.

6.7.8.8.2 Female patients over 65 should be referred for an osteoporosis evaluation if one has not been completed the previous year. Patients who have been on prednisone at a dose of 5 to 7.5 mg for more than 3 months should be evaluated for glucocorticoid induced osteoporosis. An osteoporosis evaluation may be considered for males who: are over 70, are physically inactive, have previous fragility fracture, have a BMI less than 20, or have been hypogonadal for 5 years. Evaluation may also be considered for patients on medications that can cause bone loss, patients who have suffered a fracture due to a low-impact fall or with minimum to no provocation, and women under 65 with one of the following: menopause before 40, current smoker, or body mass index less than 20. Low body weight appears to be the best predictor of osteoporosis in women younger than 65. In one adequate study, all patients aged 50 to 75 referred to an orthopaedic department for treatment of wrist, vertebral, proximal humerus, or hip fractures received bone mass density testing. 97% of patients had either osteoporosis (45%) or osteopenia (42%). Referral is important to prevent future fractures in these groups. Long-term care for osteoporosis is not covered under workers compensation even though it may be discovered due to an injury-related acute fracture.

6.7.8.9Psychotropic/Anti-anxiety/Hypnotic Agents may be useful for treatment of mild and chronic pain, dysesthesias, sleep disorders, and depression. Post-operative patients may receive medication to assure normal sleep cycles. Antidepressant medications, such as tricyclics and Selective Serotonin Reuptake Inhibitors (SSRIs), are useful for affective disorder and chronic pain management. Tricyclic antidepressant agents, in low dose, are useful for chronic pain but have more frequent side effects.

6.7.8.9.1 Anti-anxiety medications are best used for short-term treatment (i.e., less than 6 months). Accompanying sleep disorders are best treated with sedating antidepressants prior to bedtime. Frequently, combinations of the above agents are useful. As a general rule, physicians should access the patient's prior history of substance abuse or depression prior to prescribing any of these agents.

6.7.8.9.2 Due to the habit-forming potential of the benzodiazepines and other drugs found in this class, they are not routinely recommended. Refer to the Chronic Pain Guidelines which give a detailed discussion regarding medication use in chronic pain management.

6.7.8.9.3 Optimal Duration: 1 to 6 months.

6.7.8.9.4 Maximum Duration: 6 to 12 months, with monitoring.

6.7.8.10Topical Drug Delivery: Creams and patches may be an alternative treatment of localized musculoskeletal disorders. It is necessary that all topical agents be used with strict instructions for application as well as the maximum number of applications per day to obtain the desired benefit and avoid potential toxicity. As with all medications, patient selection must be rigorous to select those patients with the highest probability of compliance. Refer to "Iontophoresis" in "Passive Therapy" part of this section for information regarding topical iontophoretic agents.

6.7.8.10.1Topical Salicylates and Nonsalicylates have been shown to be effective in relieving pain in acute and chronic musculoskeletal conditions. Topical salicylate and nonsalicylates achieve tissue levels that are potentially therapeutic, at least with regard to COX inhibition. Other than local skin reactions, the side effects of therapy are minimal, although not non-existent, and the usual contraindications to use of these compounds needs to be considered. Local skin reactions are rare and systemic effects were even less common. Their use in patients receiving warfarin therapy may result in alterations in bleeding time. Overall, the low level of systemic absorption can be advantageous; allowing the topical use of these medications when systemic administration is relatively contraindicated such as is the case in patients with hypertension, cardiac failure, or renal insufficiency.

6.7.8.10.1.1 There is no evidence that topical agents are more or less effective than oral medications.

6.7.8.10.1.2 Optimal Duration: 1 week.

6.7.8.10.1.3 Maximal Duration: 2 weeks per episode.

6.7.8.10.2Capsaicin is another medication option for topical drug use in lower extremity injury. Capsaicin offers a safe and effective alternative to systemic NSAID therapy. Although it is quite safe, effective use of capsaicin is limited by the local stinging or burning sensation that typically dissipates with regular use, usually after the first 7 to 10 days of treatment. Patients should be advised to apply the cream on the affected area with a plastic glove or cotton applicator and to avoid inadvertent contact with eyes and mucous membranes.

6.7.8.10.2.1 Optimal Duration: 1 week.

6.7.8.10.2.2 Maximal Duration: 2 weeks per episode.

6.7.8.10.3Iontophoretic Agents: Refer to "Iontophoresis," in this Section 6.0, under the subsection for Passive Therapy.

6.7.8.11Tramadol is useful in relief of lower extremity pain and has been shown to provide pain relief equivalent to that of commonly prescribed NSAIDs.Tramadol is an atypical opioid with norepinephrine and serotonin reuptake inhibition. It is not considered a controlled substance in the U.S.Although Tramadol may cause impaired alertness, it is generally well tolerated, does not cause gastrointestinal ulceration, or exacerbate hypertension or congestive heart failure. Tramadol should be used cautiously in patients who have a history of seizures or who are taking medication that may lower the seizure threshold, such as MAO inhibitors, SSRIs, and tricyclic antidepressants. This medication has physically addictive properties and withdrawal may follow abrupt discontinuation and is not recommended for patients with prior opioid addiction.

6.7.8.11.1 Optimal Duration: 3 to 7 days.

6.7.8.11.2 Maximum Duration: 2 weeks. Use beyond 2 weeks is acceptable in appropriate cases.

6.8OCCUPATIONAL REHABILITATION PROGRAMS

6.8.1Non-Interdisciplinary: These generally accepted programs are work-related, outcome-focused, individualized treatment programs. Objectives of the program include, but are not limited to, improvement of cardiopulmonary and neuromusculoskeletal functions (strength, endurance, movement, flexibility, stability, and motor control functions), patient education, and symptom relief. The goal is for patients to gain full or optimal function and return to work. The service may include the time-limited use of passive modalities with progression to achieve treatment and/or simulated/real work.

6.8.1.1Work Conditioning: These programs are usually initiated once reconditioning has been completed but may be offered at any time throughout the recovery phase. It should be initiated when imminent return of a patient to modified- or full-duty is not an option, but the prognosis for returning the patient to work at completion of the program is at least fair to good.

6.8.1.1.1 Length of visit: 1 to 2 hours per day.

6.8.1.1.2 Frequency: 2 to 5 visits per week.

6.8.1.1.3 Optimum Duration: 2 to 4 weeks.

6.8.1.1.4 Maximum Duration: 6 weeks. Participation in a program beyond six weeks must be documented with respect to need and the ability to facilitate positive symptomatic or functional gains.

6.8.1.2Work Simulation: is a program where an individual completes specific work-related tasks for a particular job and return-to-work. Use of this program is appropriate when modified duty can only be partially accommodated in the work place, when modified duty in the work place is unavailable, or when the patient requires more structured supervision. The need for work place simulation should be based upon the results of a Functional Capacity Evaluation and/or Jobsite Analysis.

6.8.1.2.1 Length of visit: 2 to 6 hours per day.

6.8.1.2.2 Frequency: 2 to 5 visits per week.

6.8.1.2.3 Optimum Duration: 2 to 4 weeks.

6.8.1.2.4 Maximum Duration: 6 weeks. Participation in a program beyond six weeks must be documented with respect to need and the ability to facilitate positive symptomatic or functional gains.

6.9ORTHOTICS AND PROSTHETICS

6.9.1Fabrication/Modification of Orthotics: would be used when there is need to normalize weight-bearing, facilitate better motion response, stabilize a joint with insufficient muscle or proprioceptive/reflex competencies, to protect subacute conditions as needed during movement, and correct biomechanical problems. Footwear modifications may be necessary for work shoes and everyday shoes. Replacement is needed every six months to one year. For specific types of orthotics/prosthetics see Section 5.0, Specific Lower Extremity Injury Diagnosis, Testing and Treatment.

6.9.1.1 Time to Produce Effect: 1 to 3 sessions (includes wearing schedule and evaluation).

6.9.1.2 Frequency: 1 to 2 times per week.

6.9.1.3 Optimum/Maximum Duration: Over a period of approximately 4 to 6 weeks for casting, fitting, and re-evaluation.

6.9.2Orthotic/Prosthetic Training: is the skilled instruction (by qualified providers) in the proper use of orthotic devices and/or prosthetic limbs including stump preparation, donning and doffing limbs, instruction in wearing schedule and orthotic/prosthetic maintenance training. Training can include gait, mobility, transfer and self-care techniques.

6.9.2.1 Time to Produce Effect: 2 to 6 sessions.

6.9.2.2 Frequency: 3 times per week.

6.9.2.3 Optimum/Maximum Duration: 2 to 4 months.

6.9.3Splints or Adaptive Equipment design, fabrication and/or modification indications include the need to control neurological and orthopedic injuries for reduced stress during functional activities and modify tasks through instruction in the use of a device or physical modification of a device, which reduces stress on the injury. Equipment should improve safety and reduce risk of re-injury. This includes high and low technology assistive options such as workplace modifications, crutch or walker training, and self-care aids.

6.9.3.1 Time to Produce Effect: Immediate.

6.9.3.2 Frequency: 1 to 3 sessions or as indicated to establish independent use.

6.9.3.3 Optimum/Maximum Duration: 1 to 3 sessions.

6.10PATIENT EDUCATION: No treatment plan is complete without addressing issues of individual and/or group patient education as a means of prolonging the beneficial effects of treatment, as well as facilitating self-management of symptoms and injury prevention. The patient should be encouraged to take an active role in the establishment of functional outcome goals. They should be educated on their specific injury, assessment findings, and plan of treatment. Instruction on proper body mechanics and posture, positions to avoid, self-care for exacerbation of symptoms, and home exercise should also be addressed.

6.10.1 Time to Produce Effect: Varies with individual patient.

6.10.2 Frequency: Should occur at each visit.

6.11PERSONALITY-PSYCHOSOCIAL-PSYCHOLOGICAL INTERVENTION: Psychosocial treatment is a generally accepted, widely used and well-established intervention. This group of therapeutic and diagnostic modalities includes, but is not limited to: individual counseling, group therapy, stress management, psychosocial crises intervention, hypnosis and meditation. Any screening or diagnostic workup should clarify and distinguish between pre-existing versus aggravated versus purely causative psychological conditions. Psychosocial intervention is recommended as an important component in the total management program that should be implemented as soon as the problem is identified. This can be used alone or in conjunction with other treatment modalities. Providers treating patients with chronic pain should refer to the Delaware Workers' Compensation practice guidelines for Chronic Pain. Time to Produce Effect: 2 to 4 weeks.

6.11.1 Frequency: 1 to 3 times weekly for the first 4 weeks (excluding hospitalization, if required), decreasing to 1 to 2 times per week for the second month. Thereafter, 2 to 4 times monthly.

6.11.2 Optimum Duration: 6 weeks to 3 months.

6.11.3 Maximum Duration: 3 to 12 months. Counseling is not intended to delay but to enhance functional recovery. For select patients, longer supervised treatment may be required, and if further counseling beyond 3 months is indicated, documentation addressing which pertinent issues are pre-existing versus aggravated versus causative, as well as projecting a realistic functional prognosis, should be provided by the authorized treating provider every 4 to 6 weeks during treatment.

6.12RESTRICTION OF ACTIVITIES varies according to the specific diagnosis and the severity of the condition. Job modification/modified duty are frequently required to avoid exacerbation of the injured lower extremity. Complete work cessation should be avoided, if possible, since it often further aggravates the pain presentation. Modified return-to-work is almost always more efficacious and rarely contraindicated in the vast majority of injured workers with lower extremity injuries.

6.13RETURN-TO-WORK: Early return-to-work should be a prime goal in treating occupational injuries given the poor return-to-work prognosis for an injured worker who has been out of work for more than six months. It is imperative that the patient be educated regarding the benefits of return-to-work, work restrictions, and follow-up if problems arise. When attempting to return a patient to work after a specific injury, clear objective restrictions of activity level should be made. An accurate job description with detailed physical dutyrestrictions isoften necessary to assist the physician in making return-to-work recommendations. This may require a jobsite evaluation.

6.13.1 Employers should be prepared to offer transitional work. This may consist of temporary work in a less demanding position, return to the regular job with restrictions, or gradual return to the regular job. Company policies which encourage return-to-work with positive communication are most likely to have decreased worker disability.

6.13.2 Return-to-work is defined as any work or duty that the patient is able to perform safely . It may not be the patient's regular work. Due to the large spectrum of injuries of varying severity and varying physical demands in the work place, it is not possible to make specific return-to-work guidelines for each injury.

6.14THERAPY - ACTIVE: The following active therapies are widely used and accepted methods of care for a variety of work-related injuries. They are based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range-of-motion, and can alleviate discomfort. Active therapy requires an internal effort by the individual to complete a specific exercise or task. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual and/or tactile instruction(s). At times, the provider may help stabilize the patient or guide the movement pattern but the energy required to complete the task is predominately executed by the patient.

Patients should be instructed to continue active therapies at home as an extension of the treatment process in order to maintain improvement levels. Follow-up visits to reinforce and monitor progress and proper technique are recommended. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

The following active therapies are listed in alphabetical order:

6.14.1Activities of Daily Living (ADL) are well-established interventions which involve instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily activities such as self-care, work re-integration training, homemaking, and driving.

6.14.1.1 Time to Produce Effect: 4 to 5 treatments.

6.14.1.2 Maximum Duration: 6 weeks.

6.14.2Aquatic Therapy: is a well-accepted treatment which consists of the therapeutic use of aquatic immersion for therapeutic exercise to promote ROM, flexibility, core stabilization, endurance, strengthening, body mechanics, and pain management. Aquatic therapy includes the implementation of active therapeutic procedures in a swimming or therapeutic pool. The water provides a buoyancy force that lessens the amount of force gravity applies to the body. The decreased gravity effect allows the patient to have a mechanical advantage and more likely to have a successful trial of therapeutic exercise. Studies have shown that the muscle recruitment for aquatic therapy versus similar non-aquatic motions is significantly less. Because there is always a risk of recurrent or additional damage to the muscle tendon unit after a surgical repair, aquatic therapy may be preferred by physicians to gain early return of ROM. In some cases the patient will be able to do the exercises unsupervised after the initial supervised session. Parks and recreation contacts may be used to locate less expensive facilities for patients.

6.14.2.1 Indications include the following:

6.14.2.1.1 Post-operative therapy as ordered by the physician; or

6.14.2.1.2 Intolerance for active land-based or full-weight-bearing therapeutic procedures; or

6.14.2.1.3 Symptoms that are exacerbated in a dry environment; and

6.14.2.1.4 Willingness to follow through with the therapy on a regular basis.

6.14.2.2 The pool should be large enough to allow full extremity ROM and fully erect posture. Aquatic vests, belts, snorkels, and other devices may be used to provide stability, balance, buoyancy, and resistance.

6.14.2.3 Time to Produce Effect: 4 to 5 treatments.

6.14.2.4 Frequency: 3 to 5 times per week.

6.14.2.5 Maximum Duration: 25 Visits

6.14.2.6 A physician prescribed self-directed program is recommended after the supervised aquatics program has been established, or alternatively a transition to a self-directed dry environment exercise program.

6.14.2.7 There is some evidence that for osteoarthritis of the hip or knee, aquatic exercise probably slightly reduces pain and slightly improves function over 3 months.

6.14.3Functional Activities are the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, balance, and sensory motor integration.

6.14.3.1 Time to Produce Effect: 4 to 5 treatments

6.14.3.2 Frequency: 3 to 5 times per week.

6.14.3.3 Maximum Duration: 24 visits

6.14.3.4 Total number of visit 97110 and 97530 should not exceed 40 visits without preauthorization.

6.14.4Functional Electrical Stimulation is the application of electrical current to elicit involuntary or assisted contractions of atrophied and/or impaired muscles. Indications include muscle atrophy, weakness, sluggish muscle contraction, neuromuscular dysfunction or peripheral nerve lesion. Indications also may include an individual who is precluded from active therapy.

6.14.4.1 Time to Produce Effect: 2 to 6 treatments.

6.14.4.2 Frequency: 3 times per week.

6.14.4.3 Maximum Duration: 24 visits inclusive of electrical muscle stimulation codes.. If beneficial, provide with home unit.

6.14.5Gait Training is specialized training that promotes normal gait for a person with a faulty gait pattern secondary to lower extremity injury or surgery. Indications include the need to promote normal gait pattern with or without assistive devices; instruct in the safety and proper use of assistive devices; instruct in progressive use of more independent devices (i.e., platform-walker, to walker, to crutches, to cane); instruct in gait on uneven surfaces and steps (with and without railings) to reduce risk of fall, or loss of balance; and/or instruct in equipment to limit weight-bearing for the protection of a healing injury or surgery.

6.14.5.1 Time to Produce Effect: 2 to 6 treatments.

6.14.5.2 Frequency: 2 to 3 times per week.

6.14.5.3 Maximum Duration: 12 Visits

6.14.6Neuromuscular Re-education is the skilled application of exercise with manual, mechanical, or electrical facilitation to enhance strength; movement patterns; neuromuscular response; proprioception; kinesthetic sense; coordination; education of movement, balance and posture. Indications include the need to promote neuromuscular responses through carefully timed proprioceptive stimuli to elicit and improve motor activity in patterns similar to normal neurologically developed sequences, and improve neuromotor response with independent control.

6.14.6.1 Time to Produce Effect: 2 to 6 treatments.

6.14.6.2 Frequency: 3-5 times per week.

6.14.6.3 Maximum Duration: 36 visits.

6.14.7Therapeutic Exercise is a generally accepted treatmentwith or without mechanical assistance or resistance, may include isoinertial, isotonic, isometric and isokinetic types of exercises.There is good evidence to support the functional benefits of manual therapy with exercise, walking programs, conditioning, and other combined therapy programs. Indications include the need for cardiovascular fitness, reduced edema, improved muscle strength, improved connective tissue strength and integrity, increased bone density, promotion of circulation to enhance soft tissue healing, improvement of muscle recruitment, increased range of motion and are used to promote normal movement patterns. May also include complementary/alternative exercise movement therapy.

6.14.7.1 Time to Produce Effect: 2 to 6 treatments.

6.14.7.2 Frequency: 3 to 5 times per week.

6.14.7.3 Maximum Duration: 36 visits.

6.14.7.4 Total number of visits of 97110 & 97530 may not exceed 40 visits without pre-authorization

6.14.8Wheelchair Management and Propulsion is the instruction and training of self-propulsion and proper use of a wheelchair. This includes transferring and safety instruction. This is indicated in individuals who are not able to ambulate due to bilateral lower extremity injuries, inability to use ambulatory assistive devices, and in cases of multiple traumas.

6.14.8.1 Time to Produce Effect: 2 to 6 treatments.

6.14.8.2 Frequency: 2 to 3 times per week.

6.14.8.3 Maximum Duration: 6 visits.

6.15THERAPY - PASSIVE: Most of the following passive therapies and modalities are generally well-accepted methods of care for a variety of work-related injuries. Passive therapy includes those treatment modalities that do not require energy expenditure on the part of the patient. They are principally effective during the early phases of treatment and are directed at controlling symptoms such as pain, inflammation and swelling and to improve the rate of healing soft tissue injuries. They should be use adjunctively with active therapies to help control swelling, pain, and inflammation during the rehabilitation process. They may be used intermittently as the provider deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment.

On occasion, specific diagnoses and post-surgical conditions may warrant durations of treatment beyond those listed as "maximum." Factors such as exacerbation of symptoms, re-injury, interrupted continuity of care and comorbidities may also extend durations of care. Specific goals with objectively measured functional improvement during treatment must be cited to justify extended durations of care. It is recommended that, if no functional gain is observed after the number of treatments under "time to produce effect" has been completed alternative treatment interventions, further diagnostic studies, or further consultations should be pursued.

The following passive therapies and modalities are listed in alphabetical order.

6.15.1Continuous Passive Motion (CPM) is a form of passive motion using specialized machinery that acts to move a joint and may also pump blood and edema fluid away from the joint and periarticular tissues. CPM is effective in preventing the development of joint stiffness if applied immediately following surgery. It should be continued until the swelling that limits motion of the joint no longer develops. ROM for the joint begins at the level of patient tolerance and is increased twice a day as tolerated. Home use of CPM is expected after chondral defect surgery. CPM may be necessary for cases with ACL repair, manipulation, joint replacement or other knee surgery if the patient has been non compliant with pre-operative ROM exercises.Use of this equipment may require home visits.

6.15.1.1 Time to Produce Effect: Immediate.

6.15.1.2 Frequency: Up to 4 times a day.

6.15.1.3 Optimum Duration: Up to 3 weeks post surgical.

6.15.1.4 Maximum Duration: 3 weeks.

6.15.2Contrast Baths can be used for alternating immersion of extremities in hot and cold water. Indications include edema in the sub-acute stage of healing, the need to improve peripheral circulation and decrease joint pain and stiffness.

6.15.2.1 Time to Produce Effect: 3 treatments.

6.15.2.2 Frequency: 3 times per week.

6.15.2.3 Maximum Duration: 24 visits

6.15.3Electrical Stimulation (Attended and Unattended), an accepted treatment; once applied, requires minimal on-site supervision by the physician or non-physician provider. Indications include pain, inflammation, muscle spasm, atrophy, decreased circulation, and the need for osteogenic stimulation.

6.15.3.1 Time to Produce Effect: 2 to 4 treatments.

6.15.3.2 Maximum Duration: 24 visits

6.15.4Fluidotherapy employs a stream of dry, heated air that passes over the injured body part. The injured body part can be exercised during the application of dry heat. Indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, or reduce inflammatory response.

6.15.4.1 Time to Produce Effect: 1 to 4 treatments.

6.15.4.2 Frequency 1-5 times per week

6.15.4.3 Maximum Duration: 24 visits.

6.15.5Iontophoresis is the transfer of medication, including, but not limited to, steroidal anti-inflammatory and anesthetics, through the use of electrical stimulation. Indications include pain (Lidocaine), inflammation (hydrocortisone, salicylate), edema (mecholyl, hyaluronidase, and salicylate), ischemia (magnesium, mecholyl, and iodine), muscle spasm (magnesium, calcium); calcific deposits (acetate), scars, and keloids (chlorine, iodine, acetate).

6.15.5.1 Time to Produce Effect: 1 to 4 treatments.

6.15.5.2 Frequency: 3 times per week with at least 48 hours between treatments.

6.15.5.3 Maximum Duration: 8 visits per body region

6.15.6LASER: There is mounting evidence that low-level LASER treatment may be useful in tendonopathy, trigger points, nerve injury, and osteoarthritis of the knee. Low-level LASER treatment is therefore an accepted treatment for the above.

6.15.6.1 Time to produce effect: 4-8 treatments

6.15.6.2 Frequency: 3 sessions per week

6.15.6.3 Maximum Duration: 18 visits.

6.15.7Manual Therapy Techniques are passive interventions in which the providers use his or her hands, with or without instruments, to administer skilled movements designed to modulate pain; increase joint range of motion; reduce/eliminate soft tissue swelling, inflammation, or restriction; induce relaxation; and improve contractile and non-contractile tissue extensibility. These techniques are applied only after a thorough examination is performed to identify those for whom manual therapy would be contraindicated or for whom manual therapy must be applied with caution.

6.15.7.1Manipulation is generally accepted, well-established and widely used therapeutic intervention for lower extremity pain and dysfunction. Manipulative Treatment (not therapy) is defined as the therapeutic application of manually guided forces by an operator to improve physiologic function and/or support homeostasis that has been altered by the injury or occupational disease, and has associated clinical significance.

6.15.7.1.1 High velocity, low amplitude (HVLA) technique, chiropractic manipulation, osteopathic manipulation, muscle energy techniques, counter strain, and non-force techniques are all types of manipulative treatment. This may be applied by osteopathic physicians (D.O.), chiropractic physicians (D.C.), properly trained physical therapists (P.T.), or properly trained medical physicians. Under these different types of manipulation exist many subsets of different techniques that can be described as a) direct- a forceful engagement of a restrictive/pathologic barrier, b) indirect- a gentle/non-forceful disengagement of a restrictive/pathologic barrier, c) the patient actively assists in the treatment and d) the patient relaxing, allowing the practitioner to move the body tissues. When the proper diagnosis is made and coupled with the appropriate technique, manipulation has no contraindications and can be applied to all tissues of the body. Pre-treatment assessment should be performed as part of each manipulative treatment visit to ensure that the correct diagnosis and correct treatment is employed.

6.15.7.1.2 High velocity, low amplitude (HVLA) manipulation is performed by taking a joint to its end range of motion and moving the articulation into the zone of accessory joint movement, well within the limits of anatomical integrity. Indications for manipulation include joint pain, decreased joint motion, and joint adhesions. Contraindications to HVLA manipulation include joint instability, fractures, severe osteoporosis, infection, metastatic cancer, active inflammatory arthritides, aortic aneurysm, and signs of progressive neurologic deficits.

6.15.7.1.3 Time to produce effect for all types of manipulative treatment: 1 to 6 treatments.

6.15.7.1.4 Frequency: Up to 3 times per week for the first 4 weeks as indicated by the severity of involvement and the desired effect, then up to 2 treatments per week for the next 4 weeks. For further treatments, twice per week or less to maintain function.

6.15.7.1.5 Maximum duration: 30 visits. Extended durations of care beyond what is considered "maximum" may be necessary in cases of re-injury, interrupted continuity of care, exacerbation of symptoms, and in those patients with comorbidities. Refer to the Chronic Pain Guidelines for care beyond 6 months.

6.15.7.1.6 The combination of 97140 plus either CMT or OMT code is equal to one visit when performed on the same day. Any combination of manual therapeutic intervention exceeding 30 visits (not units) needs to go to UR. A provider may perform manual therapy and manipulation on the same day. However, the provider must include a description of the service and a rationale for why both services are needed to the same body region on the same day.

6.15.7.2Mobilization (Joint) /Manipulation

6.15.7.2.1 Mobilization is passive movement involving oscillatory motions to the involved joints. The passive mobility is performed in a graded manner (I, II, III, IV, or V), which depicts the speed of the maneuver. It may include skilled manual joint tissue stretching. Indications include the need to improve joint play, improve intracapsular arthrokinematics, or reduce pain associated with tissue impingement.

6.15.7.2.2 Time to produce effect: 4 to 6 treatments

6.15.7.2.3 Frequency: 2 to 3 times per week

6.15.7.2.4 Maximum duration: 30 visits (CPT codes 97124 and 97140 cannot exceed 30 visits in combination).

6.15.7.3Mobilization (Soft Tissue)

6.15.7.3.1 Mobilization of soft tissue is the skilled application of manual techniques designed to normalize movement patterns through the reduction of soft tissue pain and restrictions. Indications include muscle spasm around a joint, trigger points, adhesions, and neural compression.

6.15.7.3.2Nerve Gliding: consist of a series of flexion and extension movements of the toes, foot, knee, and hip that produce tension and longitudinal movement along the length of the sciatic, femoral, obturator, and other nerves of the lower extremity. These exercises are based on the principle that the tissues of the peripheral nervous system are designed for movement, and that tension and glide (excursion) of nerves may have an effect on neurophysiology through alterations in vascular and axoplasmic flow. Nerve gliding performed on a patient by the clinician should be reinforced by patient performance of similar techniques as part of a home exercise program at least twice per day.

6.15.7.3.3 Time to produce effect: 4 to 6 treatments

6.15.7.3.4 Frequency: 2 to 3 times per week

6.15.7.3.5 Maximum duration: 30 visits (CPT codes 97124 and 97140 cannot exceed 30 visits in combination).

6.15.8Massage: Manual or Mechanical - Massage is manipulation of soft tissue with broad ranging relaxation and circulatory benefits. This may include stimulation of acupuncture points and acupuncture channels (acupressure), application of suction cups and techniques that include pressing, lifting, rubbing, pinching of soft tissues by or with the practitioner's hands. Indications include edema, muscle spasm, adhesions, the need to improve peripheral circulation and range of motion, or to increase muscle relaxation and flexibility prior to exercise.

6.15.8.1 Time to produce effect: Immediate.

6.15.8.2 Frequency: 1 to 3 times per week

6.15.8.3 Maximum duration: 12 visits (CPT codes 97124 and 97140 cannot exceed 30 visits in combination).

6.15.9Paraffin Bath is a superficial heating modality that uses melted paraffin (candle wax) to treat irregular surfaces such as the foot or ankle. Indications include the need to enhance collagen extensibility before stretching, reduce muscle guarding, or reduce inflammatory response.

6.15.9.1 Time to Produce Effect: 1 to 4 treatments.

6.15.9.2 Frequency: 1 to 5 times per week.

6.15.9.3 Maximum Duration: 20 visits. If beneficial, provide with home unit or purchase if effective.

6.15.10Superficial Heat and Cold Therapy: thermal agents applied in various manners that lower or raise the body tissue temperature for the reduction of pain, inflammation, and/or effusion resulting from injury or induced by exercise. Includes application of heat just above the surface of the skin at acupuncture points. Indications include acute pain, edema and hemorrhage, need to increase pain threshold, reduce muscle spasm and promote stretching/flexibility. Cold and heat packs can be used at home as an extension of therapy in the clinic setting.

6.15.10.1 Time to produce effect: Immediate

6.15.10.2 Frequency: 2 to 5 times per week (clinic). Home treatment as needed.

6.15.10.3 Maximum duration: 1 12 visits, with maximum visits of 1 per day. If symptoms persist, consideration should be given to further diagnostic studies or other treatment options.

6.15.11Short-wave Diathermy is an accepted treatment which involves the use of equipment that exposes soft tissue to a magnetic or electrical field. Indications include enhanced collagen extensibility before stretching, reduced muscle guarding, reduced inflammatory response, and enhanced re-absorption of hemorrhage/hematoma or edema. It is an accepted modality as an adjunct to acupuncture or situation where other forms of contact superficial heat are contraindicated.

6.15.11.1 Time to produce effect: 2-4 treatments

6.15.11.2 Frequency: 2-3 times per week

6.15.11.3 Maximum Duration: 18 visits.

6.15.12Therapeutic Taping/Strapping: Fabrication and application of strapping or taping (e.g. use of elastic wraps, heavy cloths, or adhesive tape) are used to enhance performance of tasks for movements, support weak or ineffective joints or muscles, reduce or correct joint limitations or deformities, and/or protect body parts from injury. Splints and strapping are also used in conjunction with therapeutic exercise, functional training and other interventions, and should be selected in the context of the patient's need. Examples include, but are not limited to, strains and sprains of joints, patello femoral syndrome, and post surgical rehabilitation.

6.15.12.1 Time to produce effect: 3-5 treatments

6.15.12.2 Frequency: Every 1-5 days

6.15.12.3 Maximum Duration: 15 visits per involved area

6.15.13Transcutaneous Electrical Nerve Stimulation (TENS) is a generally accepted treatment. TENSshould include at least one instructional session for proper application and use. Indications include muscle spasm, atrophy, and decreased circulation and pain control. Minimal TENS unit parameters should include pulse rate, pulse width and amplitude modulation. Consistent, measurable functional improvement must be documented prior to the purchase of a home unit.

6.15.13.1 Time to Produce Effect: Immediate.

6.15.13.2 Frequency: Variable.

6.15.13.3 Maximum Duration: 3 sessions. If beneficial, provide with home unit or purchase if effective.

6.15.14Ultrasound is an accepted treatment whichincludes ultrasound with electrical stimulation andPhonophoresis. Ultrasound uses sonic generators to deliver acoustic energy for therapeutic thermal and/or non-thermal soft tissue effects. Indications include scar tissue, adhesions, collagen fiber and muscle spasm, and the need to extend muscle tissue or accelerate the soft tissue healing.

6.15.14.1 Ultrasound with electrical stimulation is concurrent delivery of electrical energy that involves a dispersive electrode placement. Indications include muscle spasm, scar tissue, pain modulation, and muscle facilitation.

6.15.14.2 Phonophoresis is the transfer of medication to the target tissue to control inflammation and pain through the use of sonic generators. These topical medications include, but are not limited to, steroidal anti-inflammatory and anesthetics.

6.15.14.3 Time to produce effect: 4 to 8 treatments

6.15.14.4 Frequency: 2-3 times per week

6.15.14.5 Maximum duration: 18 visits

6.15.15Vasopneumatic Devices are mechanical compressive devices used in both inpatient and outpatient settings to reduce various types of edema. Indications include pitting edema, lymphedema and venostasis. Maximum compression should not exceed minimal diastolic blood pressure. Use of a unit at home should be considered if expected treatment is greater than two weeks.

6.15.15.1 Time to Produce Effect: 1 to 3 treatments.

6.15.15.2 Frequency: 3 to 5 times per week.

6.15.15.3 Maximum Duration: 24 visits

6.15.16Whirlpool is conductive exposure to water at temperatures that best elicits the desired effect (cold vs. heat). It generally includes massage by water propelled by a turbine or Jacuzzi jet system and has the same thermal effects as hot packs if higher than tissue temperature. It has the same thermal effects as cold application if comparable temperature water used. Indications include the need for analgesia, relaxing muscle spasm, reducing joint stiffness, enhancing mechanical debridement and facilitating and preparing for exercise.

6.15.16.1 Time to Produce Effect: 2 to 4 treatments.

6.15.16.2 Frequency: 3 to 5 times per week.

6.15.16.3 Maximum Duration: 24 visits

6.16VOCATIONAL REHABILITATION is a generally accepted intervention. Initiation of vocational rehabilitation requires adequate evaluation of patients for quantification of highest functional level and motivation. Vocational rehabilitation may be as simple as returning to the original job or as complicated as being retrained for a new occupation.The effectiveness of vocational rehabilitation may be enhanced when performed in combination with work hardening or work conditioning.

19 Del. Admin. Code § 1342-G-6.0

17 DE Reg. 322 (9/1/2013) (Final)