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MP 8.01.18 Lysis of Epidural Adhesions

Medical Policy    
Section
Therapy
 
Original Policy Date
11/1/98
Last Review Status/Date
Reviewed with literature search/12:2012
Issue
12:2012
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

 

Lysis of epidural adhesions, also called the Racz procedure, involves passage of a catheter (Racz catheter) endoscopically or percutaneously under fluoroscopic guidance into the epidural space under general anesthetic or conscious sedation. Various protocols for breaking up adhesions and reducing pain and inflammation have been described. The catheter may then be manipulated to mechanically break up adhesions, and various agents that may include anesthetics, corticosteroids, hyaluronidase, and hypertonic saline, are injected. In some early protocols, the catheter was left in place and injections repeated over several days.

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 surgery 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 could be identified as nonfilling 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.

Endoscopic epidurolysis is also being investigated for the treatment of degenerative chronic low back pain, including spondylolisthesis, stenosis, and hernia associated with radiculopathy. Along with mechanical adhesiolysis, hyaluronidase, ciprofloxacin and ozone have been applied.


Policy

 

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.


Policy Guidelines

 

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)

Code 0027T was deleted 12/31/08. Endoscopic lysis of epidural adhesions should now be coded using miscellaneous code 64999.

There is instruction following CPT code 77003 in the CPT book that states 62263 and 62264 include fluoroscopic guidance and localization.


Benefit Application
BlueCard/National Account Issues

 

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


Rationale

 

This policy was originally created in 1998 and updated regularly with searches of the MEDLINE database. The most recent literature search was performed through October 2012. Following is a summary of the literature to date:

The evidence for lysis of epidural adhesions consists of single-center trials, most of them from a single U.S. pain management group. A number of systematic reviews of these trials have been identified for updates of this policy. A 2005 review article (1) focused on 3 randomized studies by Heavner and Manchikanti and concluded that there was moderate to strong evidence of the effectiveness of percutaneous adhesiolysis. A 2007 update of that review also concluded that there was strong evidence for short-term and moderate evidence of long-term effectiveness of percutaneous adhesiolysis and spinal endoscopy. (2) Applying the U.S. Preventive Services Task Force (USPSTF) criteria, a 2012 update of the review found fair evidence that percutaneous adhesiolysis is effective in relieving low back and/or leg pain caused by either post-lumbar surgery syndrome or spinal stenosis. (3) Complications were considered to be minimal.

In a 2008 paper, Racz and colleagues concluded, based on the literature (randomized trials and case series) and expert opinion, that evidence was strong for short-term (3 months) efficacy and moderate for long-term (>3 months) efficacy. (4) Two systematic reviews were published in 2009, one focused on endoscopic adhesiolysis and the other on the percutaneous method. Hayek et al. concluded that, based on level II-1 or II-2 evidence (1 randomized trial and 5 observational studies), endoscopic adhesiolysis provides short- and long-term relief of pain based on the USPSTF criteria. (5) Epter with Hayek and others concluded that there is level-I or -II evidence (3 randomized trials and 4 observational studies) for percutaneous adhesiolysis. (6)

The studies cited in the reviews were reviewed individually for this policy (see following sections).

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. (7) 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 (ODI), work status, opioid intake, range of motion, and psychological examination. 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, ODI, 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. (8) 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. 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. Another study compared the use of 0.9% saline solution versus 10% saline solution but did not control other aspects of the pain management program. (9)

Serious adverse events from epidural lysis have been reported. (10) In 2012, Manchikanti et al. reported a prospective observational study of complications in 10,000 fluoroscopically directed epidural injections, including more than 800 cases treated by percutaneous adhesiolysis at their institution. (11) Measured outcomes included intravascular entry of the needle, profuse bleeding, local bleeding, local hematoma, bruising, dural puncture and headache, nerve root or spinal cord irritation, infection, numbness, postoperative soreness, and increased pain. There was intravascular entry in 11.6% of cases, return of blood in 3.6%, transient nerve root irritation in 1.9%, and dural puncture in 1.8% of adhesiolysis cases. Other complications occurred in less than 1% of cases. There were no major complications in this cohort.

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 small randomized, controlled trial was identified in 2003 by Manchikanti and colleagues. Twenty-three patients with back pain of greater than 6 months’ duration were randomized 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. (12) 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 ODI 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 2009 papers by Manchikanti and colleagues (13, 14) report 1-year outcomes of 2 comparative effectiveness randomized controlled trials (RCTs) currently underway. Patients in one trial had failed back surgery syndrome (planned enrollment, 200 patients), and patients in the other had chronic low back pain (planned enrollment, 120 patients). The reason for reporting preliminary results is not given, but the authors note that in the larger study of patients with failed back surgery, having 60 patients in each group was determined to be adequate, and there are no controlled trials of patients receiving lysis of epidural adhesions for back pain related to spinal stenosis reported in the literature. The comparator in both trials was epidural corticosteroid injection. In both studies, the procedure in the intervention group included epidurography, introduction of the Racz catheter to the level of defect, adhesiolysis and/or targeted catheter positioning, repeat epidurography with confirmation of ventral and lateral filling, and injection of lidocaine, all performed in the operating room, followed by transfer to the recovery room and injection of 10% sodium chloride solution and injection of betamethasone. The control group received epidurography, introduction of the catheter up to S3 or S2, repeat epidurography, and injection of lidocaine in the operating room and injection of normal saline and betamethasone in the recovery room. For the patients with failed back surgery, significant pain relief as defined by a greater than 50% reduction in visual analogue scale (VAS) was achieved by 73% of patients in the lysis group compared to 12% in the control group (p<0.001). For patients with spinal stenosis, there were no outcomes reported at the time of publication.

Besides the preliminary nature of the reports, a number of limitations are apparent in the studies. Efficacy of the comparator, epidural corticosteroid injection, has not been clearly demonstrated. (15) The injection site in the control group may have had some impact on outcomes. Losses to follow-up in the control groups were large in both studies (10 of 60 at 6 months and 43 of 60 at 12 months in the failed back surgery study, and 10 of 25 at 6 months and 18 of 25 at 12 months in the spinal stenosis study). There were no drop-outs in the intervention groups. Thus, differential loss in follow-up is a major concern. Patients received additional treatments if needed (criteria for repeat treatment not given), and the type of treatment was based on the response to the previous injections, either after unblinding or without unblinding. Once unblinded, patients were considered withdrawn from the study. If the patient chose not to be unblinded, the prior treatment was repeated as assigned. Physicians performing procedures could not be blinded to treatment group but did not know which patients were participating in the studies. It is not reported if patients were asked which treatment they thought they received. Final reports of these studies will be considered in future updates. Finally, several other case series have been reported, but without a control group, the independent contribution of the lysis cannot be assessed.

A randomized single-blinded trial compared epidural lysis with physiotherapy in 99 patients with chronic low back pain. (16) Inclusion criteria were radicular pain with a corresponding nerve-root compressing substrate and included patients with disc protrusion and herniation, as well as epidural fibrosis. The authors did not present the results according to these separate indications. Therefore, for purposes of this policy, the study results cannot be evaluated.

In 2011, Di Donato et al. reported 48-month follow-up from a prospective case series of 234 patients with chronic low back pain due to failed back surgery syndrome, spondylolisthesis, stenosis, or hernia. (17) In addition to mechanical removal of adherences, targeted ozone, hyaluronidase and ciprofloxacin were applied. Efficacy was prospectively evaluated by an independent investigator at 1 week and 3, 6, 12, 24, 36, and 48 months. Significant improvements in VAS and ODI scores were reported throughout the 48 month follow-up. Adverse events included 32 patients (13.7%) who had sacral pain lasting at least 2 weeks and 13 patients (5.5%) who experienced a non-painful paresthesia and subsequently underwent surgical intervention. This study has a number of limitations, including the lack of information on the number of patients available for long-term follow-up and the lack of a control group.

Two additional articles by Manchikanti and colleagues were identified that retrospectively examined the outcomes of patients who underwent lysis with (n=120) or without (n=60) adjunctive endoscopy. (18, 19) 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.

Summary

Lysis of epidural adhesions involves passage of a catheter endoscopically or percutaneously under fluoroscopic guidance into the epidural space to break up adhesions and reduce pain and inflammation. The evidence for lysis of epidural adhesions with or without endoscopy is limited to a small number of randomized, controlled trials with methodologic weaknesses, nearly all from the same center. This evidence is insufficient to establish the safety and effectiveness of epidural lysis in comparison with placebo and alternative procedures Larger, high-quality, controlled studies from other research groups are needed to corroborate the currently available trials. Thus, lysis of epidural adhesions is considered investigational.

Practice Guidelines and Position Statements

The American Society of Interventional Pain Physicians updated their practice guidelines on the management of chronic spinal pain in 2009. (20) The guideline states that “evidence for percutaneous adhesiolysis is strong in managing chronic low back and lower extremity pain in post-surgery syndrome. The evidence is moderate in managing low back and lower extremity pain secondary to disc herniation producing radiculopathy. The evidence is limited in managing back and/or lower extremity pain secondary to spinal stenosis.” It further states that “the evidence is Level II-1 or II-2 for endoscopic adhesiolysis in post-lumbar laminectomy syndrome in management of pain secondary to post-lumbar surgery syndrome based on one randomized controlled trial.” The studies cited in the guideline have been reviewed for this policy.

The American Pain Society clinical practice guideline on Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain, published in 2009, does not include a discussion or conclusion on adhesiolysis and stated that “for other interventions or specific clinical circumstances, the panel found insufficient evidence from randomized controlled trials to reliably judge benefits or harms.” (21)

References:

 

  1.  
    1. 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.
    2. Trescot AM, Chopra P, Abdi S et al. Systematic review of effectiveness and complications of adhesiolysis in the management of chronic spinal pain: an update. Pain Physician 2007; 10(1):129-46.
    3. Helm Ii S, Benyamin RM, Chopra P et al. Percutaneous adhesiolysis in the management of chronic low back pain in post lumbar surgery syndrome and spinal stenosis: a systematic review. Pain Physician 2012; 15(4):E435-62.
    4. Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract 2008; 8(4):277-86.
    5. Hayek SM, Helm S, Benyamin RM et al. Effectiveness of spinal endoscopic adhesiolysis in post lumbar surgery syndrome: a systematic review. Pain Physician 2009; 12(2):419-35.
    6. Epter RS, Helm S, 2nd, Hayek SM et al. Systematic review of percutaneous adhesiolysis and management of chronic low back pain in post lumbar surgery syndrome. Pain Physician 2009; 12(2):361-78.
    7. 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.
    8. Manchikanti L, 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.
    9. 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.
    10. Wagner KJ, Sprenger T, Pecho C et al. [Risks and complications of epidural neurolysis -- a review with case report]. Anasthesiol Intensivmed Notfallmed Schmerzther 2006; 41(4):213-22.
    11. Manchikanti L, Malla Y, Wargo BW et al. A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections. Pain Physician 2012; 15(2):131-40.
    12. 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.
    13. Manchikanti L, Cash KA, McManus CD et al. The preliminary results of a comparative effectiveness evaluation of adhesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: a randomized, equivalence controlled trial. Pain Physician 2009; 12(6):E341-54.
    14. Manchikanti L, Singh V, Cash KA et al. A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial. Pain Physician 2009; 12(6):E355-68.
    15. Staal JB, de Bie RA, de Vet HC et al. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976) 2009; 34(1):49-59.
    16. 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):365-9.
    17. Di Donato A, Fontana C, Pinto R et al. The effectiveness of endoscopic epidurolysis in treatment of degenerative chronic low back pain: a prospective analysis and follow-up at 48 months. Acta Neurochir Suppl 2011; 108:67-73.
    18. 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.
    19. Manchikanti L, Pakanati RR, Pampati V. The value and safety of epidural endoscopic adhesiolysis. Am J Anesthesiol 2000; 27(5):275-9.
    20. Manchikanti L, Boswell MV, Singh V et al. American Society of Interventional Pain Physicians. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician 2009; 12(1):699-802. Available online at: http://www.asipp.org/documents/ComprehensiveEvidence-BasedGuidelinesforInterventionalTechniquesintheManagementofChronicSpin.pdf. Last accessed October, 2011.
    21. Chou R, Loeser JD, Owens DK et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976) 2009; 34(10):1066-77.

 

Codes

Number

Description

CPT See Policy Guidelines  
ICD-9 Procedure 03.6 Lysis of adhesions of spinal cord and nerve roots
ICD-9 Diagnosis 349.0-349.9 Other and unspecified disorders of the nervous system (code range)
HCPCS J7130 Hypertonic saline solution, 50 or 100 mEq, 20 cc vial
ICD-10-CM (effective 10/1/14)   Investigational for all relevant diagnoses
  G96.8 Other specified disorders of central nervous system
  G96.9 Disorder of central nervous system unspecified
  G97.1 Other reaction to spinal and lumbar puncture
  G98.8 Other disorders of the nervous system
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services.
  00NW3ZZ, 00NW4ZZ Surgical, central nervous system, release, cervical spinal cord, code by approach (percutaneous or percutaneous endoscopic)
  00NX3ZZ, 00NX4ZZ Surgical, central nervous system, release, thoracic spinal cord, code by approach (percutaneous or percutaneous endoscopic)
  00NY3ZZ, 00NY4ZZ Surgical, central nervous system, release, lumbar spinal cord, code by approach (percutaneous or percutaneous endoscopic)
Type of Service Therapy  
Place of Service Inpatient
Physician Office
 

Index

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


Policy History

 

Date Action Reason
11/01/98 Add to Therapy section New policy
11/01/99 Replace policy New CPT code; policy unchanged
07/12/02 Replace policy Policy updated; policy statement unchanged
4/29/03 Replace policy Policy updated and revised; CPT codes added, include discussion of endoscopic guidance; policy statement revised to address endoscopic guidance
12/17/03 Replace policy Policy updated; new references added. No change in policy statement
07/15/04 Replace policy Policy reviewed with literature search. No change in policy statement
06/27/05 Replace policy Policy reviewed with literature search; no change in policy statement, reference numbers 8, 9, and 14-17 added
7/20/06 Replace policy Policy reviewed with literature search; no change in policy statement, reference number 18 added. Policy guidelines section updated regarding inclusion of fluoroscopy in the CPT codes for the procedures
08/02/07 Replace policy Policy updated with literature search; no change in policy statement, reference numbers 19-22 added
02/12/09 Replace policy Policy updated with literature review, reference number 23 added. No change in policy statement
03/11/10 Replace policy Policy updated with literature review, reference numbers 4, 5, 14 – 17 added, prior references renumbered and some removed. No change in policy statement
12/9/10 Replace policy - coding update only ICD-10 codes added to policy
03/10/11 Replace policy Policy updated with literature review, reference number 18 added, no change in policy statement
12/08/11 Replace policy Policy updated with literature review through September 2011, reference added and references reordered, no change in policy statement
12/13/12 Replace Policy Policy updated with literature review through October 2012, references 3 and 11 added and references reordered, policy statement unchanged