19 Del. Admin. Code § 1342-C-6.0

Current through Register Vol. 27, No. 12, June 1, 2024
Section 1342-C-6.0 - Therapeutic Procedures - Non-Operative

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 or 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 screening 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.

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. There is some scientific evidence to support its use. 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, DO[,] DC 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 and inflammation, and to increase blood flow to an area and increase range of motion. Indications include joint pain, joint stiffness, soft tissue pain and inflammation, paresthesia, post-surgical pain relief, muscle spasm, and scar tissue pain.
* Time to produce effect: 3 to 6 treatments
* Frequency: 1 to 3 times per week
* Course duration: 14 treatments
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.

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.

* Time to produce effect: 3 to 6 treatments
* Frequency: 1 to 3 times per week
* Course duration: 14 treatments

6.1.3Other 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.
* Time to produce effect: 3 to 6 treatments
* Frequency: 1 to 3 times per week
* Course duration: 14 treatments

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 sessions (1 course) may be documented with respect to need and ability to facilitate positive symptomatic or functional gains.

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).

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.

Indications for biofeedback include individuals who are suffering from musculoskeletal injury where 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.

* Time to produce effect: 3 to 4 sessions
* Frequency: 1 to 2 times per week
* Maximum duration: 10 to 12 sessions. Treatment beyond 12 sessions must be documented with respect to need, expectation, and ability to facilitate positive symptomatic or functional gains.

6.3INJECTIONS - THERAPEUTIC are generally accepted, well-established procedures that may play a significant role in the treatment of patients with upper 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; and (c) diminish pain and 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.
6.3.1Steroid Injections: may provide both diagnostic and therapeutic value in treating a variety of upper extremity cumulative trauma disorders. These include neuropathies, tendonitis or bursitis about the elbow, wrist, or hand. In contrast, there is no evidence to support their therapeutic use in other upper extremity compressive neuropathies; however, it is a widely accepted procedure.

Steroid injections provide a potent anti-inflammatory effect, which is usually short term in duration, lasting weeks or months. Injections should always be used as an adjunctive treatment in the context of a physical exercise and rehabilitation program.

For epicondylitis, there is good evidence that although steroid injections with physical therapy may provide short-term symptomatic relief, there is no benefit over placebo injections at 6 months. A program of physical rehabilitation in combination with judicious use of anti-inflammatory medications should be the core treatment for epicondylitis.

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

Contraindications: General contraindications include local or systemic infection, bleeding disorders, and allergy to medications used.

Local Steroid Injections:

* Time to produce effect: 3 days
* Frequency: monthly
* Maximum duration: 3 injections

6.3.2Trigger Point Injections: are generally accepted, although used infrequently in uncomplicated cases. They may, however, be used to relieve myofascial pain and facilitate active therapy and stretching of the affected areas, and as an adjunctive treatment in combination with other treatment modalities, such as functional restoration programs, including stretching therapeutic exercise. Trigger point injections should be utilized primarily for the purpose of facilitating functional progress. The Division does not recommend their routine use in the treatment of upper extremity injuries.
* Time to produce effect: Local anesthetic 30 minutes; 24 to 48 hours for no anesthesia.
* Frequency: Weekly. Suggest no more than 4 injection sites per session per week to avoid significant post-injection soreness.
* Maximum duration: 8 weeks. Occasional patients may require 2 to 4 repetitions of trigger point injection series over a 1 to 2 year period.
6.3.3 Other Injections: Some early evidence exists to support Autologous Blood Injection may be used for medial/lateral epicondylitis. This can be repeated for a total of 2-3 injections given roughly 6 weeks apart.
6.4JOB SITE ALTERATION Early evaluation and training of body mechanics and other ergonomic factors are essential for every injured worker and should be done by a qualified individual. In some cases, this requires a job site evaluation. Some evidence supports alteration of the work site in the early treatment of Cumulative Trauma Disorder. There is no single factor or combination of factors that is proven to prevent or ameliorate CTD, but a combination of ergonomic and psychosocial factors are generally considered to be important. Physical factors that may be considered include use of force, repetition, awkward positions, upper extremity vibration, cold environment, and contact pressure on the nerve. Psychosocial factors to be considered include pacing, degree of control over job duties, perception of job stress, and supervisory support.

The job analysis and modification should include input from the employee, employer, and ergonomist or other professional familiar with work place evaluation. The employee must be observed performing all job functions in order for the job site analysis to be valid. Periodic follow-up is recommended to evaluate effectiveness of the intervention and need for additional ergonomic changes.

6.4.1Ergonomic changes: should be made to modify the hazards identified. In addition, workers should be counseled to vary tasks throughout the day whenever possible. OSHA suggests that workers who perform repetitive tasks, including keyboarding, take 15-30 second breaks every 10 to 20 minutes, or 5-minute breaks every hour. Mini breaks should include stretching exercises.
6.4.2Interventions: should consider engineering controls, e.g., mechanizing the task, changing the tool used, or adjusting the job site; or administrative controls, e.g., adjusting the time an individual performs the task.
6.4.3Seating Description: The following description may aid in evaluating seated work positions: The head should incline only slightly forward, and if a monitor is used, there should be 18-24 inches of viewing distance with no glare. Arms should rest naturally, with forearms parallel to the floor, elbows at the sides, and wrists straight or minimally extended. The back must be properly supported by a chair, which allows change in position and backrest adjustment. There must be good knee and legroom, with the feet resting comfortably on the floor or footrest. Tools should be within easy reach, and twisting or bending should be avoided.
6.4.4Job Hazard Checklist: The following Table 4 is adopted from Washington State's job hazard checklist, and may be used as a generally accepted guide for identifying job duties which may pose ergonomic hazards. The fact that an ergonomic hazard exists at a specific job, or is suggested in the table, does not establish a causal relationship between the job and the individual with a musculoskeletal injury. However, when an individual has a work-related injury and ergonomic hazards exist that affect the injury, appropriate job modifications should be made. Proper correction of hazards may prevent future injuries to others, as well as aid in the recovery of the injured worker.

Table 4: Identifying Job Duties Which May Pose Ergonomic Hazards

Type of Job Duty Hours per Day
Pinching an unsupported object(s) weighing 2 lbs or more per hand, or pinching with a force of 4 lbs or more per hand (comparable to pinching a half a ream of paper): 1. Highly repetitive motion 2. Palmar flexion greater than 30 degrees, dorsiflexion greater than 45 degrees, or radial deviation greater than 30 degrees ------------------------------------------------------ 3. No other risk factors More than 3 hours total/day More than 4 hours total/day
Gripping an unsupported object(s) weighing 10 lbs or more/hand, or gripping with a force of 10 lbs or more/hand (comparable to clamping light duty automotive jumper cables onto a battery): *Handles should be rounded and soft, with at least 1-2.5" in diameter grips at least 5" long. 1. Highly repetitive motion 2. Palmar flexion greater than 30 degrees, dorsiflexion greater than 45 degrees, or radial deviation greater than 30 degrees ------------------------------------------------------ 3. No other risk factors More than 3 hours total/day More than 4 hours total/day
Repetitive Motion (using the same motion with little or no variation every few seconds) excluding keying activities: 1. High, forceful exertions with the hands, with palmar flexion greater than 30 degrees, dorsiflexion greater than 45 degrees, or radial deviation greater than 30 degrees ------------------------------------------------------ 2. No other risk factors More than 2 hours total/day More than 6 hours total/day
Intensive Keying: 1. Palmar flexion greater than 30 degrees, dorsiflexion greater than 45 degrees, or radial deviation greater than 30 degrees ------------------------------------------------------ 2. No other risk factors More than 4 hours total/day More than 7 hours total/day
Repeated Impact: 1. Using the hand (heel/base of palm) as a hammer more than once/minute More than 2 hours total/day
Vibration: Two determinants of the tolerability of segmental vibration of the hand are the frequency and the acceleration of the motion of the vibrating tool, with lower frequencies being more poorly tolerated at a given level of imposed acceleration, expressed below in multiples of the acceleration due to gravity (10m/sec./sec.). 1. Frequency range 8-15 Hz and acceleration 6 g 2. Frequency range 80 Hz and acceleration 40 g 3. Frequency range 250 Hz and acceleration 250 g ------------------------------------------------------- 4. Frequency range 8-15 Hz and acceleration 1.5 g 5. Frequency range 80 Hz and acceleration 6 g 6. Frequency range 250 Hz and acceleration 20 g More than 30 minutes at a time --------------------------- More than 4 hours at a time

6.5MEDICATIONS Medication use in the treatment of CTD is appropriate for controlling acute and chronic pain and inflammation. Use of medications will vary widely due to the spectrum of injuries from simple strains to post-surgical analgesia. 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.

Acetaminophen is an effective and safe initial analgesic. Nonsteroidal anti-inflammatory drugs (NSAIDs) are useful in the treatment of inflammation, and for pain control. Pain is subjective in nature and should be evaluated using a scale to rate effectiveness of the analgesic in terms of functional gain. Other medications, including antidepressants, may be useful in selected patients with chronic pain (Refer to the Division's Chronic Pain Guidelines). Narcotics are rarely indicated for treatment of upper extremity CTDs, and they should be primarily reserved for the treatment of acute severe pain for a limited time on a case-by-case basis. Topical agents may be beneficial in the management of localized upper extremity pain.

The following are listed in alphabetical order:

6.5.1Acetaminophen: 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 doses over 10 gm/day or in chronic alcohol use.
6.5.2Minor Tranquilizer/Muscle Relaxants: are appropriate for muscle spasm, mild pain and sleep disorders.
6.5.3Narcotics: medications should be prescribed with strict time, quantity and duration guidelines, and with definitive cessation parameters. Adverse effects include respiratory depression, impaired alertness, and the development of physical and psychological dependence.
* treatment.
6.5.4Nonsteroidal 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 advises that many NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infraction, and stroke, which can be fatal. Naproxen sodium does not appear to be associated with increased risk of vascular events. 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 may be 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) and liver and renal function should be monitored at least every six months in patients on chronic NSAIDs and initially when indicated.
6.5.4.1 Non-selective Nonsteroidal Anti-Inflammatory Drugs -

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.

6.5.4.2 Selective Cyclo-oxygenase-2 (COX-2) Inhibitors -

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.

COX-2 inhibitors should not be first-line for low risk patients who will be using an 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 sulfanilamide allergic patients.

6.5.5Psychotropic/Anti-anxiety/Hypnotic Agents: may be useful for treatment of mild and chronic pain, dysesthesias, sleep disorders, and depression. Antidepressant medications, such as tricyclics and Selective Serotonin Reuptake Inhibitors (SSRIs), are useful for affective disorders and chronic pain management. Tricyclic antidepressant agents, in low dose, are useful for chronic pain but have more frequent side effects.

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 assess the patient for a prior history of substance abuse or depression prior to prescribing any of these agents.

6.5.6Tramadol: is useful in relief of upper extremity pain and has been shown to provide pain relief equivalent to that of commonly prescribed narcotics. 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 monoamine oxidase (MAO) inhibiters, SSRIs, and tricyclic antidepressants. This medication has physically addictive properties and withdrawal may follow abrupt discontinuation. It is not recommended for those with prior opioid addiction.
6.5.7Topical Drug Delivery: may be an alternative treatment for localized musculoskeletal disorders and is an acceptable form of treatment in selected patients although there is no scientific evidence to support its use. It is necessary that all topical agents be used with strict instructions for application as well as 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 choose those patients with the highest probability of compliance. Refer to "Iontophoresis" in the Passive Therapy section for information regarding topical iontophoretic agents.
6.6OCCUPATIONAL REHABILITATION PROGRAMS
6.6.1Non-Interdisciplinary: These 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.
6.6.1.1 Work Conditioning/Simulation

This program may begin once a patient is out of the acute phase of injury and will be able to tolerate this program.

These programs are usually initiated after the acute phase has been completed and offered at any time throughout the recovery phase. Work conditioning 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.

The need for work place simulation should be based upon the results of a Functional Capacity Evaluation and/or Jobsite Analysis.

* Length of visit: 1 to 4 hours per day.
* Frequency: 2 to 5 visits per week
* Maximum duration: 8 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.

6.6.1.2 Work Hardening

Work Hardening is an interdisciplinary program addressing a patient's employability and return to work. It includes a progressive increase in the number of hours per day that a patient completes work simulation tasks until the patient can tolerate a full workday. This is accomplished by addressing the medical, psychological, behavioral, physical, functional, and vocational components of employability and return-to-work.

This can include a highly structured program involving a team approach or can involve any of the components thereof. The interdisciplinary team should, at a minimum, be comprised of a qualified medical director who is board certified with documented training in occupational rehabilitation; team physicians having experience in occupational rehabilitation; occupational therapist; physical therapist; case manager; and psychologist. As appropriate, the team may also include: chiropractor, RN, vocational specialist or Certified Biofeedback Therapist.

* Length of visit: Up to 8 hours/day
* Frequency: 2 to 5 visits per week
* Maximum duration: 8 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.

6.7PATIENT EDUCATION No treatment plan is complete without addressing issues of individual patient and/or group 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 take an active role in the establishment of functional outcome goals, and should be educated on his or her specific injury, assessment findings, and plan of treatment. Education and instruction in proper body mechanics and posture, positions to avoid task/tool adaptation, self-care for exacerbation of symptoms, and home exercise/task adaptation should also be addressed.
6.8RETURN-TO-WORK is therapeutic, assuming the work is not likely to aggravate the basic problem or increase long-term pain. The practitioner must provide specific physical limitations per the Physician's Form. The following physical limitations should be considered and modified as recommended: lifting, pushing, pulling, crouching, walking, using stairs, bending at the waist, awkward and/or sustained postures, tolerance for sitting or standing, hot and cold environments, data entry and other repetitive motion tasks, sustained grip, tool usage and vibration factors. Even if there is residual chronic pain, return-to-work is not necessarily contraindicated.

The practitioner should understand all of the physical demands of the patient's job position before returning the patient to full duty and should receive clarification of the patient's job duties. Clarification must be provided by the employer or, if necessary, including, but not limited to, an occupational health nurse, occupational therapist, vocational rehabilitation specialist, or an industrial hygienist.

6.9SLEEP DISTURBANCES are a common secondary symptom of CTD. Although primary insomnia may accompany pain as an independent co-morbid condition, it more commonly occurs, secondary to the pain condition itself. Exacerbations of pain often are accompanied by exacerbations of insomnia; the reverse can also occur. Sleep laboratory studies have shown disturbances of sleep architecture in pain patients. Loss of deep slow-wave sleep and increase in light sleep occur and sleep efficiency, the proportion of time in bed spent asleep, is decreased. These changes are associated with patient reports of non-restorative sleep.

Many affected patients develop behavioral habits that exacerbate and maintain sleep disturbances. Excessive time in bed, irregular sleep routine, napping, low activity, and worrying in bed are all maladaptive responses that can arise in the absence of any psychopathology. There is some evidence that behavioral modification, such as patient education and group or individual counseling, can be effective in reversing the effects of insomnia. Behavioral modifications are easily implemented and can include:

6.9.1 Maintaining a regular sleep schedule, retiring and rising at approximately the same time on weekdays and weekends.
6.9.2 Avoiding daytime napping.
6.9.3 Avoiding caffeinated beverages after lunchtime
6.9.4 Making the bedroom quiet and comfortable, eliminating disruptive lights, sounds, television sets, and keeping a bedroom temperature of about 65°F.
6.9.5 Avoiding alcohol or nicotine within two hours of bedtime.
6.9.6 Avoiding large meals within two hours of bedtime.
6.9.7 Exercising vigorously during the day, but not within two hours of bedtime, since this may raise core temperature and activate the nervous system.
6.9.8 Associating the bed with sleep and sexual activity only, using other parts of the home for television, reading and talking on the telephone.
6.9.9 Leaving the bedroom when unable to sleep for more than 20 minutes, returning to the bedroom when ready to sleep again.

These modifications should be undertaken before sleeping medication is prescribed for long term use.

6.10THERAPY-PASSIVE 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 used in adjunct with active therapies to help control swelling, pain and inflammation during the rehabilitation process. They may be used intermittently as a therapist deems appropriate or regularly if there are specific goals with objectively measured functional improvements during treatment.
6.10.1Electrical Stimulation (Unattended and Attended): once applied, requires minimal on-site supervision by the physician or non-physician provider. Indications include pain, inflammation, muscle spasm, atrophy, and decreased circulation.
6.10.2Extracorporeal shock wave treatment: Consists of the application of pulses of high pressure sound to soft tissues, similar to lithotriptors. It has been investigated for its effectiveness in the treatment of lateral epicondylitis. It has not been shown to have an advantage over other conservative treatments and remains investigational. It is not recommended.
6.10.3Iontophoresis: is the transfer of medication, including, but not limited to, steroidal anti-inflammatories and anesthetics, through the use of electrical stimulation. Indications include pain (Lidocaine), inflammation (hydrocortisone, salicylate), edema (mecholyl, hyaluronidase, salicylate), ischemia (magnesium, mecholyl, iodine), muscle spasm (magnesium, calcium), calcific deposits (acetate), scars and keloids (chlorine, iodine, acetate).
6.10.4Laser irradiation: Consists of the external application of an array of visible and infrared wavelengths to soft tissues. Time and frequency dependent on severity and chronicity of problem.
6.10.5Manual Therapy Techniques: are passive interventions in which the providers use his or her hands 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.
6.10.5.1Manipulation: is generally accepted, well-established and widely used therapeutic intervention for low back pain. 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.

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.), chiropractors (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

6.10.5.1.1 direct- a forceful engagement of a restrictive/pathologic barrier,
6.10.5.1.2 indirect- a gentle/non-forceful disengagement of a restrictive/pathologic barrier,
6.10.5.1.3 the patient actively assists in the treatment and
6.10.5.1.4 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.

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.

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

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) need to go to UR.

6.10.5.2Mobilization (Joint) /Manipulation

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.

* Time to produce effect: 4 to 6 treatments
* Frequency: 2 to 3 times per week
* Maximum duration: 30 visits (CPT codes 97124 and 97140 can not exceed 30 visits in combination).

6.10.5.3Mobilization (Soft Tissue)

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.

Nerve Gliding: consist of a series of flexion and extension movements of the hand, wrist, elbow, shoulder, and neck that produce tension and longitudinal movement along the length of the median and other nerves of the upper 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. Biomechanical principles have been more thoroughly studied than clinical outcomes. 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.

* Time to produce effect: 4 to 6 treatments
* Frequency: 2 to 3 times per week
* Maximum duration: 30 visits (CPT codes 97124 and 97140 cannot exceed 30 visits in combination).

6.10.6Massage: 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 practitioners' 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.
* Time to produce effect: Immediate.
* Frequency: 1 to 3 times per week
* Maximum duration: 12 visits (CPT codes 97124 and 97140 cannot exceed 30 visits in combination).
6.10.7Orthotics/Immobilization with Splinting: is a generally accepted, well-established and widely used therapeutic procedure. Splints may be effective when worn at night or during portions of the day, depending on activities. Splints should be loose and soft enough to maintain comfort while supporting the involved joint in a relatively neutral position. Splint comfort is critical and may affect compliance. Although off-the-shelf splints are usually sufficient, custom thermoplastic splints may provide better fit for certain patients.

Splints may be effective when worn at night or during portions of the day, depending on activities; however, splint use is rarely mandatory. Providers should be aware that over-usage is counterproductive, and counsel patients to minimize daytime splint use in order avoid detrimental effects, such as, stiffness and dependency over time.

* Time to produce effect: 1-4 weeks
* Frequency: Daytime intermittent or night use, depending on symptoms and activities.
* Maximum duration: 2 to 4 months. If symptoms persist, consideration should be given to further diagnostic studies or to other treatment options.

6.10.8Superficial Heat and Cold Therapy: are thermal agents applied in various manners that lowers or raises 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.
* Time to produce effect: Immediate
* Frequency: 2 to 5 times per week (clinic). Home treatment as needed.
* Maximum duration: 12 visits with maximum visit 1 per day. If symptoms persist, consideration should be given to further diagnostic studies or other treatment options.
6.10.9Ultrasound: uses sonic generators to deliver acoustic energy for therapeutic thermal and/or nonthermal soft tissue effects. Indications include scar tissue, adhesions, collagen fiber and muscle spasm, and to improve muscle tissue extensibility and soft tissue healing. Ultrasound with electrical stimulation is concurrent delivery of electrical energy that involves dispersive electrode placement. Indications include muscle spasm, scar tissue, pain modulation and muscle facilitation. 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.
* Time to produce effect: 4 to 8 treatments
* Frequency: 2-3 times per week
* Maximum duration: 18 visits
6.11THERAPY-ACTIVE therapies are based on the philosophy that therapeutic exercise and/or activity are beneficial for restoring flexibility, strength, endurance, function, range of motion, and alleviating discomfort. Active therapy requires an internal effort by the individual to complete a specific exercise or task, and thus assists in developing skills promoting independence to allow self-care after discharge. This form of therapy requires supervision from a therapist or medical provider such as verbal, visual, and/or tactile instructions. At times a 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. Home exercise can include exercise with or without mechanical assistance or resistance and functional activities with assistive devices.

Interventions are selected based on the complexity of the presenting dysfunction with ongoing examination, evaluation and modification of the plan of care as improvement or lack thereof occurs. Change and/or discontinuation of an intervention should occur if there is attainment of expected goals/outcome, lack of progress, lack of tolerance and/or lack of motivation. Passive interventions/modalities may only be used as adjuncts to the active program.

6.11.1Activities of Daily Living: Supervised instruction, active-assisted training, and/or adaptation of activities or equipment to improve a person's capacity in normal daily living activities such as self-care, work re-integration training, homemaking, and driving.
* Time to produce effect: 4 to 5 treatments
* Maximum of 10 sessions
6.11.2Aquatic Therapy: is a well-accepted treatment which consists of the therapeutic use of aquatic immersion for therapeutic exercise to promote strengthening, core stabilization, endurance, range of motion, flexibility, 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 have a successful trial of therapeutic exercise. The therapy may be indicated for individuals who:
* cannot tolerate active land-based or full-weight bearing therapeutic procedures
* require increased support in the presence of proprioceptive deficit;
* are at risk of compression fracture due to decreased bone density;
* have symptoms that are exacerbated in a dry environment;
* would have a higher probability of meeting active therapeutic goals than in a land-based environment.

The pool should be large enough to allow full extremity range of motion and fully erect posture. Aquatic vests, belts and other devices can be used to provide stability, balance, buoyancy, and resistance.

* Time to produce effect: 4 to 5 treatments
* Frequency: 3 to 5 times per week
* Maximum duration: 24 visits

A self-directed program is recommended after the supervised aquatics program has been established, or, alternatively a transition to a land-based environment exercise program.

6.11.3Functional Activities: are the use of therapeutic activity to enhance mobility, body mechanics, employability, coordination, and sensory motor integration.
* Time to produce effect: 4 to 5 treatments
* Frequency: 3 to 5 times per week
* Maximum duration: 24 visits

Total number of visit 97110 and 97530 should not exceed 36 visits without pre-authorization

6.11.4Neuromuscular 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.
* Time to produce effect: 2 to 6 treatments
* Frequency: 3-5 times per week
* Maximum duration: 24 visits
6.11.5Proper Work Techniques: Please refer to the "Job Site Evaluation" and "Job Site Alteration" sections of these guidelines.
6.11.6Therapeutic Exercise: with or without mechanical assistance or resistance may include isoinertial, isotonic, isometric and isokinetic types of exercises. 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. Can also include complementary/alternative exercise movement therapy.
* Time to produce effect: 2 to 6 treatments
* Frequency: 3 to 5 times per week
* Maximum duration: 36 visits

Total number of visit 97110 and 97530 should not exceed 36 visits without pre-authorization

6.12RESTRICTION OF ACTIVITIES Continuation of normal daily activities is the recommendation for Cumulative Trauma Disorders with or without neurologic symptoms. 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 CTD.
6.13VOCATIONAL REHABILITATION is a generally accepted intervention. Initiation of vocational rehabilitation requires adequate evaluation of patients for quantification of highest functional level, motivation, and achievement of maximum medical improvement. Vocational rehabilitation may be as simple as returning to the original job or as complicated as being retrained for a new occupation.

19 Del. Admin. Code § 1342-C-6.0

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