Lysis of epidural adhesions may also be known as the RACZ procedure or epidural neurolysis. Following an epidurogram to determine the presence or absence of epidural adhesions, a special epidural catheter (Racz catheter) is inserted into the epidural space and injection of hypertonic saline with or without steroids or other medications is performed. This policy addresses lysis of epidural adhesions using hypertonic solutions.

Investigational/Not Medically Necessary:

Hypertonic saline injections, as a technique for lysis of epidural adhesions with or without steroids, analgesics or hyaluronidase, or with or without endoscopic guidance is considered investigational/not medically necessary.

Rationale

Theoretically, the use of hypertonic saline results in a mechanical disruption of the adhesions. It may also function to reduce edema within previously scarred and/or inflamed nerves. Adhesions may also be disrupted by the manipulation of the catheter at the time of the injection.

A literature search based on the MEDLINE database identified a randomized, double blinded trial that examined the role of mechanical epidural lysis of adhesions with or without additional hypertonic saline compared to placebo (Manchikanti, 2004). A total of 75 patients were randomized to one of three groups: 1. a control group with catheterization without adhesiolysis followed by injection of local anesthetic, normal saline and steroid; 2. catheterization and adhesiolysis followed by injection of local anesthetic, normal saline and steroid; 3. adhesiolysis followed by injection of local anesthetic, hypertonic saline and steroids. Repeat treatments were permitted. Prior to three months, repeat treatments consisted of the originally assigned treatments, while after three months unblinding was permitted, if requested. After 12 months, all patients were unblinded. Outcome measures at 3, 6 and 12 months included VAS pain scale, Oswestry Disability Index, work status, opioid intake, range of motion exercises and psychological evaluation. At three months, when all patients remained blinded, the authors reported significant improvement in all outcome measures. The treatment effect was quite strong, for example in both the adhesiolysis groups the mean VAS score dropped from 8.8 at the start of the study to between 4.7 and 4.8 at 3 months. Similarly, the Oswestry Disability index dropped from 37 to between 26 and 24. The proportion of patients using opioids dropped from 72% to 16%. This dramatic response in a small number of patients raises questions about the reproducibility of results. In addition, while the patient and physical therapist were blinded to the treatment group, it is not clear if the treating physician was blinded. The protocol states that the treatment assigned was blinded to the “reviewing physician,” but it is not clear who this physician is. For example, additional treatments were permitted, “based on response,” and it is unclear if this assessment was done in a blinded manner.

Another prospective randomized blinded clinical trial studied epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica (Veihelmann, 2006). In this study, 99 patients with chronic low back pain
were randomly assigned into either a group with physiotherapy (n = 52) or a second group undergoing epidural neuroplasty (n = 47). Patients were assessed before treatment and after 3, 6, and 12 months post treatment by a blinded investigator. After 3 months, the visual analog scale (VAS) score for back and leg pain was significantly reduced in the epidural neuroplasty group, and the need for pain medication was reduced in both groups. Furthermore, the VAS for back and leg pain as well as the Oswestry disability score were significantly reduced until 12 months after the procedure in contrast to the group that received conservative treatment. Although the researchers concluded that epidural neuroplasty results in significant alleviation of pain and functional disability in patients with chronic low back pain, they also acknowledged that further prospective randomized double-blinded studies should be performed to prove the effectiveness of epidural neuroplasty in comparison to placebo and to open discectomy procedures.

Lysis of adhesions has also been performed using endoscopic guidance. However, a literature search did not identify any controlled studies that evaluated the effectiveness of spinal endoscopy as an adjunct to epidural lysis. One article retrospectively examined the outcomes of patients who underwent lysis with (n=120) or without (n=60) adjunctive endoscopy. However, this study did not include a control group, and thus scientific conclusions regarding the contribution of endoscopy are not possible. No articles were identified that focused on the use of hyaluronidase as a component of the therapy. The current literature lacks well designed clinical studies demonstrating the efficacy and long term outcomes of this procedure.

Background/Overview

Epidural fibrosis with or without adhesive arachnoiditis most commonly occurs as a complication of spinal surgery and may be included under the diagnosis of "failed back syndrome." Both conditions result from manipulation of the supporting structures of the spine and are related to inflammatory reactions that result in the entrapment of nerves within dense scar tissue. Arachnoiditis is most frequently seen in patients who have undergone multiple surgical procedures. Lysis of epidural adhesions with epidural injections of hypertonic saline, in conjunction with steroids, and analgesics or hyaluronidase has been investigated as a treatment option. Theoretically, the use of hypertonic saline results in a mechanical disruption of the adhesions. Adhesions may also be disrupted by the manipulation of the catheter at the time of the injection. The hypertonic saline may also function to reduce edema within previously scarred and/or inflamed nerves. Hyaluronidase may be added to the injectate to further the penetration of the drugs into the scar tissue. The injections may be performed with or without endoscopic guidance.

Definitions

Arachnoiditis: inflammation of the arachnoid membrane often with involvement of the subjacent subarachnoid space.

Endoscope:  a usually highly flexible viewing instrument with capabilities of diagnostic (biopsy) or even therapeutic functions through special channels. 

Endoscopy: the visual inspection of any cavity of the body by means of an endoscope.

Neurolysis: destruction of nerve tissue; freeing of a nerve from inflammatory adhesions.

Radiculopathy: any disease of the spinal nerve roots and spinal nerves. Radiculopathy is characterized by pain which seems to radiate from the spine to extend outward to cause symptoms away from the source of the spinal nerve root irritation. Causes of radiculopathy include deformities of the discs between the building blocks of the spine (the vertebrae).

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. Cahana A, Mavrocordatos P, Geurts JW, Groen GJ. Do minimally invasive procedures have a place in the treatment of chronic low back pain? Expert Rev Neurother. 2004; 4(3):479-490.
2. Manchikanti L, Pampati V, Bakhit CE, Pakanati RR. Non-endoscopic and endoscopic adhesiolysis in post lumbar laminectomy syndrome. Pain Physician. 1999; 2(3):52-58. 
3. Manchikanti L, Rivera JJ, Pampati V, et al. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: A randomized, double blind trial. Pain Physician. 2004; 7(2): 177-186. 
4. Veihelmann A, Devens C, Trouillier H, et al. Epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica: a prospective randomized blinded clinical trial. J Orthop Sci. 2006; 11(4):365–369.

Index

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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