19 Del. Admin. Code § 1342-B-7.0

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

Section 1342-B-7.0 - Therapeutic Procedures - Operative

When considering operative intervention in chronic pain management, the treating physician must carefully consider the inherent risk and benefit of the procedure. All operative intervention should be based on a positive correlation with clinical findings, the clinical course, and diagnostic tests. A comprehensive assessment of these factors should have led to a specific diagnosis with positive identification of the pathologic condition. Surgical procedures are seldom meant to be curative and would be employed in conjunction with other treatment modalities for maximum functional benefit. Functional benefit should be objectively measured and includes the following:

. Return-to-work or maintaining work status.

. Fewer restrictions at work or performing activities of daily living.

. Decrease in usage of medications.

. Measurable functional gains, such as increased range of motion or documented increase in strength.

. Education of the patient should include the proposed goals of the surgery, expected gains, risks or complications, and alternative treatment.

7.1 NEUROSTIMULATION

7.1.1 Description - Neurostimulation is the delivery of low-voltage electrical stimulation to the spinal cord or peripheral nerves to inhibit or block the sensation of pain. This is a generally accepted procedure that has limited use. May be most effective in patients with chronic, intractable limb pain who have not achieved relief with oral medications, rehabilitation therapy, or therapeutic nerve blocks, and in whom the pain has persisted for longer than 6 months.

Particular technical expertise is required to perform this procedure and is available in some neurosurgical, rehabilitation, and anesthesiology training programs and fellowships. Physicians performing this procedure must be experienced in neurostimulation implantation and participate in ongoing injection training workshops, such as those sponsored by the Internal Society for Injection Studies or as sponsored by implant manufacturers.

7.1.2 Indications - Failure of conservative therapy including active and/or passive therapy, medication management, or therapeutic injections. Habituation to narcotic analgesics in the absence of a history of addictive behavior does not preclude the use of neurostimulation. Only patients who meet the following criteria should be considered candidates for neurostimulation:

7.1.2.1 A diagnosis of a specific physical condition known to be chronically painful has been made on the basis of objective findings; and

7.1.2.2 All reasonable non-surgical treatment has been exhausted; and

7.1.2.3 Pre-surgical psychiatric or psychological evaluation has been performed and has demonstrated motivation and long-term commitment without issues of secondary gain; and

7.1.2.4 There is no evidence of addictive behavior. (Tolerance and dependence to narcotic analgesics are not addictive behaviors and do not preclude implantation.); and

7.1.2.5 The topography of pain and its underlying pathophysiology are amenable to stimulation coverage; and

7.1.2.6 A successful neurostimulation screening test of 2-3 days. A screening test is considered successful if the patient (a) experiences a 50% decrease in pain, which may be confirmed by visual analogue scale (VAS.

7.1.2.7 For spinal cord stimulation, a temporary lead is implanted and attached to an external source to validate therapy effectiveness.

7.1.3 Operative Treatment - Implantation of stimulating leads connected by extensions to either an implanted neurostimulator or an implanted receiver powered by an external transmitter. The procedure may be performed either as an open or a percutaneous procedure, depending on the presence of epidural fibrosis and the anatomical placement required for optimal efficacy.

7.1.4 Post-Operative Considerations - MRI is contraindicated after placement of neurostimulators.

7.1.5 A mandatory second opinion is required to confirm the rationale for the procedure for non malignant pain.

7.2 INTRATHECAL DRUG DELIVERY

7.2.1 Description - This mode of therapy delivers small doses of medications directly into the cerebrospinal fluid. Clinical studies are conflicting regarding long-term, effective pain relief in patients with non-malignant pain. As with other routes of drug administration, escalation of dose may be required. Typically, pump refills are needed every 2-3 months.

7.2.2 General Indications - It may be considered only in rare cases where all other commonly used methods to control pain have failed and must be based on the recommendation of at least one physician experienced in chronic pain management in consultation with the primary treating physician. Patients should only be selected for intrathecal drug delivery if they have opioid-responsive pain but cannot tolerate the effects of systemic administration. The patient must have good to excellent pain relief with a test dose prior to pump implantation. The patient must be motivated for the procedure, and must understand the potential for complications and requirements of treatment maintenance.

7.2.3 Surgical Indications - Failure of conservative therapy including active and/or passive therapy, medication management, or therapeutic injections. Only patients who meet the following criteria should be considered candidates for intraspinal analgesic infusions:

7.2.3.1 A diagnosis of a specific physical condition known to be chronically painful has been made on the basis of objective findings; and

7.2.3.2 All reasonable non-surgical treatment has been exhausted; and

7.2.3.3 Pre-surgical psychiatric or psychological evaluation has been performed and has demonstrated motivation and long-term commitment without issues of secondary gain;

7.2.3.4 There is no evidence of addictive behavior. (Tolerance and dependence to narcotic analgesics are not addictive behaviors and do not preclude implantation.); and

7.2.3.5 A successful trial. A screening test is considered successful if the patient (a) experiences a 50% decrease in pain, which may be confirmed by VAS.

7.2.3.6 A mandatory second opinion is required to confirm the rationale for the procedure in non malignant pain.

7.3 FACET RHIZOTOMY

7.3.1 Description - A procedure designed to denervate the facet joint by ablating the periarticular facet nerve branches. There is good evidence to support this procedure for the cervical spine and some evidence in lumbar spine.

7.3.2 Indications - Pain of facet origin, unresponsive to active and/or passive therapy. All patients must have a successful response to diagnostic medial nerve branch blocks. A successful response is considered to be a 50% or greater relief of pain for the length of time appropriate to the local anesthetic.

7.3.3 Operative Treatment - Percutaneous radio-frequency rhizotomy is the procedure of choice over alcohol, phenol, or cryoablation. Position of the probe using fluoroscopic guidance is required.

19 Del. Admin. Code § 1342-B-7.0