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 result from manipulation of the supporting structures of the spine. Epidural fibrosis can occur in isolation, but adhesive arachnoiditis is rarely present without associated epidural fibrosis. Arachnoiditis is most frequently seen in patients who have undergone multiple surgical procedures.

Both conditions are related to inflammatory reactions that result in the entrapment of nerves within dense scar tissue, increasing the susceptibility of the nerve root to compression or tension. The condition most frequently involves the nerves within the lumbar spine and cauda equina. Signs and symptoms indicate the involvement of multiple nerve roots and include low back pain, radicular pain, tenderness, sphincter disturbances, limited trunk mobility, muscular spasm or contracture, and motor sensory and reflex changes. Typically, the pain is characterized as constant and burning. In some cases, the pain and disability are severe, leading to analgesic dependence and chronic invalidism.

Lysis of epidural adhesions, using fluoroscopic guidance, with epidural injections of hypertonic saline in conjunction with corticosteroids and analgesics, has been investigated as a treatment option. 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. Finally, manipulating the catheter at the time of the injection may disrupt adhesions. Spinal endoscopy has been used to guide the lysis procedure. Prior to the use of endoscopy, adhesions can be identified as non-filling lesions on fluoroscopy. Using endoscopy guidance, a flexible fiberoptic catheter is inserted into the sacral hiatus, providing 3-D visualization to steer the catheter toward the adhesions, to more precisely place the injectate in the epidural space and onto the nerve root. Various protocols for lysis have been described; in some situations, the catheter may remain in place for several days for serial treatment sessions.

Catheter-based techniques for lysis of epidural adhesions, with or without endoscopic guidance, are considered investigational. Techniques used either alone or in combination include mechanical disruption with a catheter and/or injection of hypertonic solutions with corticosteroids, analgesics, or hyaluronidase.

The following CPT codes specifically identify the injection of hypertonic saline, which may be performed over the course of multiple or single days.

62263: Percutaneous lysis of epidural adhesions using solution injection (e.g., hypertonic saline, enzyme) or mechanical means (e.g., catheter) including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 2 or more days

62264; as above but limited to 1 day only

Note: As noted here, the protocols for lysis of epidural adhesions vary. Some institutions may perform lysis of epidural adhesions as an in-patient procedure, performed in multiple sessions over a course of several days through an indwelling catheter. In the descriptor of the CPT book, it is noted that CPT code 62263 describes the percutaneous insertion and removal of an epidural catheter and that code 62263 is NOT reported for each adhesiolysis treatment, but should be reported ONCE to describe the entire series of injection/infusion spanning 2 or more treatment days.

In 2003, the following CPT code was introduced to describe lysis of adhesions with endoscopic guidance:

0027T: Endoscopic lysis of epidural adhesions with direct visualization using mechanical means (e.g., spinal endoscopic catheter system) or solution injection (e.g., normal saline)

There is instruction following CPT code 76005 in the CPT book that states 62263, 62264 and 0027T include fluoroscopic guidance and localization.

BlueCard/National Account Issues

Lysis of epidural adhesions using hypertonic saline may be offered as one component of a multi-modality pain management program.

Percutaneous Lysis of Adhesions without Spinal Endoscopy

In 2004, Manchikanti and colleagues published the results of a trial that randomized 75 patients to 1 of 3 groups, either a control group consisting of catheterization without adhesiolysis, or to adhesiolysis with or without additional hypertonic saline. (1) All patients received epidural injections of local anesthetic and corticosteroids. Patient selection criteria included a history of chronic low back pain of at least 2 years that had failed conservative treatment, including epidural corticosteroid injections. Outcomes were assessed at 3, 6, and 12 months based on a visual analog scale (VAS), Oswestry Disability Index, work status, opioid intake, range of motion, and psychological exam. Unblinding was allowed at 3 months, based on treatment response, followed by crossover to another treatment group. It is not clear from the published article how this assessment was made. In the control group, 6 of the 25 patients were unblinded at 3 months, and 18 of the 25 patients were unblinded at 18 months. Once patients were unblinded they were considered withdrawn and no subsequent data were collected and the results of their last assessment were carried forward to the next assessment. For example, if a patient was unblinded at 3 months, the same outcomes were reported at 6 and 12 months. Therefore, this discussion will focus on the 3-month outcomes.

Significant differences in pain relief, Oswestry Disability Index, and range of motion were noted between the 2 treatment groups and the control group. For example, the mean VAS score was not significantly improved in the control group, dropping from 8.9 to 7.7, while in the treatment groups the VAS dropped from 8.8 to 4.6. A total of 40% of the control group had no response with the first treatment, compared to only 16% in the adhesiolysis group. At 3 months, no patient in the control group reported significant relief, defined as at least 50% relief, while at least 64% of patients in the treatment group reported significant relief. While this study is adequately designed and does report positive results, its small size and the fact that it is a single institution study limit interpretation. The dramatic effect reported in this study should be confirmed in a larger multi-institutional study.

Other reported trials have significant methodologic issues that limit interpretation. One controlled trial included 45 patients who were randomized to receive either a 1- or 3-day course of lysis of epidural adhesions, although details of the randomization and treatment protocols are not provided, and it is not clear what, if any, randomization took place. The trial also included a conservatively treated control group of 15 patients composed of patients who either refused the treatment option, or whose insurance refused to pay. (2) Although the study did not provide details on how pain relief was evaluated, describing only a verbal 10-point pain scale, the study concluded that a total of 97% of the treatment group reported at least 50% pain relief with 1 to 3 injections at 3 months, which fell to 93% at 6 months, and 47% at 1 year. There was no significant improvement in the control group. However, the lack of a placebo control and the obvious bias of the control group limit interpretation of these findings. One other identified article compared the use of 0.9% saline solution versus 10% saline solution, but did not control other aspects of the pain-management program. (3) Epidural lysis of adhesions is discussed in chapters of textbooks and in numerous review articles; however, the absence of controlled trials makes scientific conclusions impossible regarding its efficacy. (4-7) A 2005 review article focused on 3 randomized studies by Heavner and Manchikanti and concluded that there was moderate to strong evidence of the effectiveness of percutaneous adhesiolysis. (8) In 2005, the American Society of Interventional Pain Physicians issued evidence-based practice guidelines on the management of chronic spinal pain. These guidelines concluded that there was “strong evidence” in support of percutaneous adhesiolysis based on a discussion of the same 3 studies. (9) However, these 3 studies have been reviewed separately in this policy (2-4), with the conclusion that methodologic issues limit interpretation of results.

Percutaneous Lysis of Adhesions with Spinal Endoscopy

In 2003, a new category III CPT code was introduced to describe lysis of epidural lesions using endoscopic guidance. One randomized controlled trial was identified. Manchikanti and colleagues randomized 23 patients with back pain of greater than 6 months’ duration to receive either spinal endoscopy followed by injection of local anesthetic or corticosteroid (control group) or the above procedure with the addition of lysis of adhesions with normal saline and mechanical disruption with the fiberoptic endoscope. (10) The trial was double blinded. Patient selection criteria included failure of conservative management, including failure of prior attempts at lysis of adhesions using hypertonic saline. The principal outcomes included changes in the VAS scores and Oswestry Disability scale at 6 months. In the control group, the mean VAS score dropped from 8.7 at baseline to 7.6 at 6 months, while the scores in the intervention group dropped from 9.2 at baseline to 5.7 at 6 months. The difference between the control and intervention group was statistically significant. There was also a significant difference between the 2 groups in the percentage of patients experiencing at least a 50% reduction in pain. Blinding appeared to be successful as 6 of the 16 patients in the control group believed that they were in the intervention group, and 8 of 23 patients in the intervention group believed that they were in the control group. While this study reports promising results, its small size limits interpretation. Two articles were identified that retrospectively examined the outcomes of patients who underwent lysis with (n=120) or without (n=60) adjunctive endoscopy. (11,12) As these articles are authored by the same investigator, it is likely that they include overlapping patients. However, these studies did not include a control group, and thus scientific conclusions regarding the contribution of endoscopy are not possible. Finally, several other case series have been reported, but without a control group, the independent contribution of the lysis cannot be assessed. (13-17) The 2005 guidelines from the American Society of Interventional Physicians concluded that there was “strong evidence” for spinal endoscopic adhesiolysis in terms of short-term relief and “moderate” evidence for long-term relief. (9) These guidelines referenced the same articles as reviewed here.

2006 Update

A literature review was completed in May 2006. The findings from this review did not alter the findings and conclusions noted above. While controlled studies are now being conducted (18), they continue to be small, single-institution studies. Larger, multi-institution studies are needed to adequately evaluate this procedure.

References:

1. 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):177-86.
2. Manchikanti LM, Pampati V, Fellows B et al. Role of one day epidural adhesiolysis in management of chronic low back pain: a randomized clinical trial. Pain Physician 2001; 4(2):153-66.
3. Heavner JE, Racz GB, Raj P. Percutaneous epidural neuroplasty: prospective evaluation of 0.9% NaCl versus 10% NaCl with or without hyaluronidase. Reg Anesth Pain Med 1999; 24(3):202-7.
4. Racz GD, Heavner JE, Raj PP. Nonsurgical management of spinal radiculopathy by the use of lysis of adhesions. In: Aronoff GM (ed). Evaluation and Treatment of Chronic Pain. Baltimore: William and Wilkins, 1998.
5. Anderson SR, Racz GB, Heavner J. Evolution of epidural lysis of adhesions. Pain Physician 2000; 3(3):262-70.
6. Manchikanti L, Pakanati RR, Bakhit CE et al. Role of adhesiolysis and hypertonic saline neurolysis in management of low back pain: evaluation of modification of the Racz protocol. Pain Digest 1999; 9:91-9.
7. Manchikanti L, Bakhit CE. Percutaneous lysis of epidural adhesions. Pain Physician 2000; 3(1):46-64.
8. Chopra P, Smith HS, Deer TR et al. Role of adhesiolysis in the management of chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician 2005; 8(1):87-100.
9. Boswell MV, Shah RV, Everett CR et al. Interventional techniques in the management of chronic spinal pain: evidence based practice guidelines. Pain Physician 2005; 8(1):1-47.
10. Manchikanti L, Rivera JJ, Pampati V et al. Spinal endoscopic adhesiolysis in the management of chronic low back pain: a preliminary report of a randomized, double-blind trial. Pain Physician 2003; 6(3):259-67.
11. Manchikanti L, Pampati V, Bakhit CE et al. Non-endoscopic and endoscopic adhesiolysis in post-lumbar laminectomy syndrome. Pain Physician 1999; 2(3):52-8.
12. Manchikanti L, Pakanati RR, Pampati V et al. The value and safety of epidural endoscopic adhesiolysis. Am J Anesthesiol 2000; 27(5):275-9.
13. Geurts JW, Kallewaard JW, Richardson J et al. Targeted methylprednisolone acetate/hyaluronidase/clonidine injection after diagnostic epiduroscopy for chronic sciatica: a prospective, 1-year follow up study. Reg Anesth Pain Med 2002; 27(4):343-52.
14. Manchikanti L, Pampati V, Bakhit CE et al. Non-endoscopic and endoscopic adhesiolysis in post lumbar laminectomy syndrome: a one-year outcome study and cost effectiveness analysis. Pain Physician 1999; 2(3):52-8.
15. Igarashi T, Hirabayashi Y, Seo N et al. Lysis of adhesions and epidural injection of steroid/local anesthetic during epiduroscopy potentially alleviate low back and leg pain in elderly patients with lumbar spinal stenosis. Br J Anaesth 2004; 93(2):181-7.
16. Richardson J, McGurgan P, Cheema Set al. Spinal endoscopy in chronic low back pain with radiculopathy. A prospective case series. Anaesthesia 2001; 56(5):454-60.
17. Saberski L. A retrospective analysis of spinal canal endoscopy and laminectomy outcomes data. Pain Physician 2000; 3(2):193-6.
18. Manchikanti L, Boswell MV, Rivera JJ et al.A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain[ISRCTN 16558617]. BMC Anesthesiol 2005; 5:10 (accessible at http://www.biomedcentral.com/1471-2253/5/10 ).

Epidural Neurolysis
Hypertonic Saline Injections
Injections, Epidural, Hypertonic Saline
Lysis of Epidural Adhesions
Neurolysis, Epidural