Clinical Policy: Lysis of Epidural Lesions Form

CENTENE®
Corporation

Clinical Policy: Lysis of Epidural Lesions
Reference Number: CP.MP.116
Date of Last Revision: 04/25

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal
information.

**Description**
Epidural adhesiolysis, also known as epidural neuroplasty, lysis of epidural adhesions, or caudal
neuroplasty, is a minimally invasive surgery for patients with chronic back pain associated with
epidural fibrosis or adhesions. Adhesions are commonly caused by scarring after spinal
interventions, and are associated with post-laminectomy syndrome or failed back surgery
syndrome. Adhesions may also be caused by normal aging of the spine and spinal disorders such
as lumbar disc herniation and spinal stenosis.

**Policy/Criteria**
1. It is the policy of health plans affiliated with Centene Corporation® that current medical
literature does not support the efficacy of lysis of epidural lesions, including percutaneous
epidural adhesiolysis and endoscopic epidural adhesiolysis, with or without use of an
indwelling epidural Racz catheter.

**Background**
Percutaneous lysis of epidural adhesions with epidural injections of hypertonic saline, in
conjunction with steroids and analgesics or hyaluronidase, is an interventional pain management
technique that has been investigated as a treatment option in managing chronic intractable low
back pain caused by extensive peridural scarring. In theory, 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.

Spinal endoscopy has been used to guide the lysis of adhesions. Prior to use of endoscopy,
adhesions can be identified as non-filling lesions on fluoroscopy. To provide 3-D visualization
using endoscopy guidance, a flexible fiberoptic catheter is inserted to the sacral hiatus to steer
the catheter toward the adhesions allowing the practitioner the ability 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.

*Evidence for percutaneous adhesiolysis*
Controlled trials have found short-term positive effects of percutaneous epidural adhesiolysis in
patients with chronic, refractory back pain and lower extremity pain.¹⁻⁵ However, these studies
are limited by methodological limitations including somewhat high attrition rates, insufficient
blinding and inadequate statistical power to establish safety. Furthermore, many of the studies
were conducted at the same interventional pain management center, which could limit the
representativeness of the results obtained by the researchers.¹

CENTENE®
Corporation

CLINICAL POLICY
Lysis of Epidural Lesions

A Hayes review of six randomized controlled trials (RCTs) with search data through September
7, 2018 was completed for percutaneous epidural adhesiolysis treatment for adults with chronic
low back pain (CLBP) unresponsive to other treatments.⁶ This review showed a small body of
low-quality evidence, suggesting that percutaneous adhesiolysis may cause improvement in
patients with CLBP who have failed conservative treatment.⁶ Hayes states that “while the
evidence suggests potential short- and intermediate-term efficacy of this procedure in patients
with CLBP, whether or not epidural adhesions are the actual source of the pain in these patients
has been debated, and long-term outcomes remain to be determined in well-designed trials.”⁶⁶
Additionally, there has been a lack of RCTs published in the past five years, and there are
currently no registered clinical studies researching percutaneous adhesiolysis.⁶

*Evidence for endoscopic adhesiolysis*
Research conducted on endoscopic epidural adhesiolysis is generally positive, with significant
improvements in pain with endoscopic adhesiolysis compared to control groups.⁷⁻¹⁰ The studies
conducted thus far have been largely observational, however.⁷⁻¹⁰ In a 2012 RCT conducted by
Manchikanti et al., endoscopic adhesiolysis was found to significantly improve pain at three, six,
and 12 months in patients who had failed conservative treatment for low back pain, compared to
endoscopy alone.¹¹ A systematic review of endoscopic adhesiolysis was conducted by Helm et
al. and included three observational studies and one RCT.¹² The systematic review concluded
that there is fair quality evidence of positive effects, citing paucity of literature as a limitation.¹²

**Guideline Recommendations**
**American Society of Interventional Pain Physicians (ASIPP)**
A 2021 update of epidural interventions from guidelines published in 2013 by the American
Society of Interventional Pain Physicians now rates the quality of evidence for percutaneous
adhesiolysis as moderate to strong for managing chronic low back and lower extremity pain due
to disc herniation and spinal stenosis and strong for post-surgery syndrome after failure of
conservative treatment and fluoroscopically guided epidural injections.¹³ The limitation of this
guideline update continues to be a paucity of high quality RCTs assessing the intervention.¹³ The
guideline update does not address endosiolysis.

**National Institute for Health and Care Excellence (NICE)**
In a 2010 statement, the UK National Institute for Clinical Excellence (NICE) concluded,
"current evidence on therapeutic endoscopic division of epidural adhesions is limited to some
evidence of short-term efficacy, and there are significant safety concerns. Therefore this
procedure should only be used with special arrangements for clinical governance, consent and
audit or research."¹²

**Coding Implications**
 The date of posting
may not be the effective date of this clinical policy.