Medical Policy

 

Subject: Lysis of Epidural Adhesions
Document #: SURG.00072 Publish Date:    06/06/2018
Status: Reviewed Last Review Date:    05/03/2018

Description/Scope

This document addresses lysis of epidural adhesions, which refers to the disruption of fibrous tissue in the epidural space of the spine. Epidural adhesions are similar to scar tissue and are most commonly observed following invasive procedures, such as spinal surgery, catheter placement or injections. This procedure is also known as the RACZ procedure or epidural neurolysis. During the procedure, a special epidural catheter is inserted into the epidural space for injection of hypertonic saline with or without other medications or manipulation of the catheter alone. Additional lysis methods have been proposed, such as radiofrequency ablation.

Note: Please see the following related document for additional information:

Position Statement

Investigational and Not Medically Necessary:

Lysis of epidural adhesions by any means, including but not limited to, use of hypertonic saline injections, mechanical catheter manipulation, hyaluronidase, whether done with or without steroids or analgesics, is considered investigational and not medically necessary.

Rationale

Theoretically, the use of hypertonic saline in conjunction with corticosteroids and analgesics results in a disruption of the adhesions, thus relieving the pain caused by nerve entrapment. 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 or by catheter manipulation alone, without injected medication.

In 2004, Manchikanti reported on a double-blind, placebo controlled trial that examined the role of mechanical epidural lysis of adhesions with or without additional hypertonic saline compared to placebo. A total of 75 participants 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. Repeated treatments within the assigned group were permitted for up to 3 months. Beyond that time, unblinding was permitted if requested. After 12 months, all participants were unblinded. Outcome measures at 3, 6, and 12 months included Visual Analog Score (VAS) pain scale, Oswestry Disability Index (ODI), work status, opioid intake, range of motion exercises and psychological evaluation. At 3 months, when all participants remained blinded, the authors reported significant improvement in all outcome measures in the two active treatment groups compared to the control group. The treatment effect was quite strong, for example in both 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 ODI dropped from 37 to between 26 and 24. The proportion of participants using opioids dropped from 72% to 16%. This dramatic response in a small number of individuals raises questions about the reproducibility of results. In addition, while the participants 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. The same group of investigators reported on an unblinded study of 45 participants who were randomly assigned to either a control group (n=15) who were treated conservatively, or to an active treatment group (n=30) treated with adhesiolysis. The participants were evaluated over 1.5 to 3 years. The treatment group reported increased improvement in terms of pain and function and other outcome measures compared to the control group. However, the small number of participants and lack of a placebo control group limits the interpretation of these results. It should also be noted that the majority of studies addressing adhesiolysis are authored by the same group of investigators, raising questions about the reproducibility of results (Manchikanti, 2001).

Veihelmann (2006) studied 99 participants with chronic low back pain who were randomly assigned to receive either physiotherapy (n=52) or epidural neurolysis (n=47) using ropivacaine, triamcinolone and 10% saline injected via catheter. Participants were assessed before treatment and after 3, 6, and 12 months post treatment by a blinded investigator. This trial did not include a placebo control. After 3 months, the 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 participants with chronic low back pain, they also acknowledged that further prospective randomized double-blind studies should be performed to prove the effectiveness of epidural neuroplasty in comparison to placebo and to open discectomy procedures.

Takeshima and colleagues (2009) performed epidural adhesiolysis on 28 individuals with failed back surgery syndrome (FBSS), to examine whether the location of the adhesions was responsible for successful pain relief. The authors found that in those where only the epidural space was separated by adhesiolysis, there was a significant improvement in the Roland–Morris disability questionnaire (RDQ) score until 12 weeks after adhesiolysis, but the score gradually returned to the preoperative value thereafter. Among those where the nerve root responsible for radicular pain was separated, there was a long-term improvement in the RDQ and the ODI. Among participants where both the epidural space and the nerve root responsible for pain were separated, there was a 12-week improvement in the RDQ score and 24-week improvements in the ODI scores. The authors acknowledged the limitations of this study were size, treatment comparison and blinding. Larger, well designed controlled studies are necessary to establish epiduroscopic adhesiolysis as a safe and effective therapy for individuals with FBSS. 

Donato and colleagues (2011) reported a 48 month follow-up from a prospective case series of 234 individuals with chronic low back pain due to FBSS, spondylolisthesis, stenosis or hernia. 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 individuals (13.7%) having sacral pain lasting at least 2 weeks and 13 individuals (5.5%) experiencing a non-painful paresthesia and who subsequently underwent surgical intervention. Although positive outcomes were reported, the study was limited by the lack of a control group and a large number of participants lost to follow-up at 48 months.

Chun-jing et al (2012) reported on a single-center, double-blind population of 92 Chinese individuals with FBSS who received lysis of epidural adhesions. The participants were randomly divided into two groups, a control group of 46 participants and a treatment group of 46 participants. The control group received an epidural injection of dexamethasone, while the treatment group received lysis of epidural adhesions followed by epidural injection of dexamethasone. Participants were evaluated prior to the procedure, at 7 days, 1 month, and 6 months following the procedure. All participants completed VAS questionnaires. VAS score for the control group before operation was 7.03, 5.47 at 7 days, 6.00 at 1 month and 6.21 at 6 months. VAS for the treatment group before operation was 6.95, 3.50 at 7 days, 3.55 at 1 month and 3.71 at 6 months. Six participants in the treatment group failed lysis and did not show any change in VAS scores. Sixteen of the 92 participants were lost to follow-up. The authors concluded that the decrease in VAS scores in the control group may have been attributed to the use of dexamethasone. Although the VAS scores for the treatment group were lower than the control group, this is a small group of participants and there was no long-term follow-up.

Manchikanti and colleagues (2012) reported on the 2-year outcomes of a randomized, controlled trial in which 120 participants were randomly assigned to either the control group which consisted of caudal epidural injections with catheterization (n=60) or the intervention group (n=60) which consisted of percutaneous adhesiolysis with lidocaine, hypertonic sodium chloride and betamethasone. The participants were post lumbar surgery at least 6 months prior to enrollment and all had failed conservative management. The outcome measures used were Numeric Rating Scale (NRS), the ODI 2.0, opioid use and employment status. Assessments were carried out at 3, 6, 12, 18, and 24 months post-treatment. At 2 years, 8 participants in the control group were available for follow-up and 52 participants had been unblinded, compared to the intervention group in which 54 participants were available for follow-up and 4 participants were unblinded. Pain relief and improvement in functional status were noted in 70% of the participants in the intervention group at the end of 1 year and 82% at the end of 2 years, compared to 5% at the end of years 1 and 2 in the control group. There was no change in employment status. Opioid use was decreased from the baseline, but there were no significant differences between the groups. The authors acknowledged that, given the subjective outcome of pain relief, an equivalence study with no placebo/sham control is difficult to interpret; secondly, there was a large control group dropout rate (n=43 in control group; n=3 in intervention group) at 12 months.

In 2016, Pereira and others published the results of a small case series study involving 24 subjects with epidural scar tissue following lumbar discectomy who were treated with a combination of different techniques. The techniques used were dependent on the consistency of the fibrous tissue found in each subject. Mild adhesions were lysed by distention of the epidural space with small boluses of saline solution and by mechanical dissection with the tip of a Fogarty catheter. Denser areas of fibrosis were treated by manipulating the inflated balloon of the Fogarty catheter or removing them with a 1 mm flexible endoscopic grasping forceps, if no blood vessels could be identified in the vicinity. The thickest and hardest fibrotic areas were initially treated with Fogarty catheter followed by radiofrequency ablation. All subjects received epidural steroids and anesthetic injection following surgical treatment. One subject reported no improvement at 1 month and withdrew from the study; all other subjects were followed for 12 months. The authors reported a statistically significant improvement in low back and lower limb pain at all assessment periods up to 12 months (p<0.0001 for all). A pain relief over 50% was achieved in 71% of the participants at 1 month, 63% at 3 and 6 months, and 38% at 12 months. Measures on the Oswestry Disability Index were significantly improved at the 15-day, 30-day, and 90-day time points (p<0.001, 0.001, and 0.019, respectively). One subject developed facet joint pain distinct from the pre-intervention pain at 6 months post treatment and underwent medial branch radiofrequency neurotomy with pain relief. No other percutaneous interventions were performed in any other subjects. One subject reported neck pain after irrigation of the epidural space which resolved spontaneously. Another subject presented with an S1 sensory deficit following the procedure with full recovery within 48 hours. No infections, additional neurological deficits, dural tears, or any other complication related to the procedure was noted. This small, unblinded or controlled study has multiple methodologic flaws which prevent adequate assessment of the efficacy of epidural lysis of adhesions.

Hong Park and Ho Lee (2017) investigated the correlation between level of pain reduction and epidurographic findings in subjects with lumbar spinal stenosis. In this prospective study, 78 subjects underwent percutaneous adhesiolysis procedures and had postprocedural follow-up appointments at 2 weeks, 1 month, and 3 months. The VAS score assessment was used to obtain outcome measures at all follow-up appointments. The investigators found that “no significant correlation between postprocedural VAS score and status of filling defects (yes or no) was evident during the three-month follow-up period” (2 weeks: p=0.44; 1 month: p=0.83; 3 months: p=0.75) (Hong Park, 2017).

Also in 2017, Rapcan and colleagues published a randomized, multicenter, double-blind, parallel pilot study comparing the efficacy of drugs (hyaluronidase and corticosteroid DEPO-Medrol) administered into the epidural space during epiduroscopy and mechanical adhesiolysis. Before epiduroscopy, 48 subjects were randomized into either Group A (mechanical adhesiolysis) or Group B (hyaluronidase and corticosteroid DEPO-Medrol). At the 6-month and 12-month double-blinded postoperative examinations, primary outcomes, which were pain intensity spreading in the back and legs and evaluation of the Oswestry Disability Index (ODI), were assessed. The authors found that the ODI score significantly improved in both groups at the 6-month appointment (p<0.05), but returned to baseline at the 12-month appointment for both groups. Also, results were similar with back and leg pain in that they were significantly improved in both groups at the 6-month appointment (p<0.05), but the improvement diminished by the 12-month appointment for Group A back pain and leg pain for both groups (p>0.05). Based on these results, mechanical adhesiolysis and adhesiolysis with corticosteroid and hyaluronidase administration both do not have long-term benefits.

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 for 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” (Chou, 2009).

The American Society of Interventional Pain Physicians updated its practice guidelines on the Management of Chronic Spinal Pain in 2013. The guideline provided the following guidance:

There is fair evidence for lumbar percutaneous adhesiolysis for managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. Percutaneous adhesiolysis is recommended after failure of conservative management of physical therapy, chiropractic, drug therapy, structured exercise program, and fluoroscopically directed epidural injections. Spinal epidural endoscopic adhesiolysis is not discussed because there is limited evidence and the procedure is rarely used (Manchikanti, 2013).

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 individuals 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 while some advocates contend adhesiolysis can be obtained by the manipulation of the catheter with or without the injection of hypertonic saline. The hypertonic saline may also function to reduce edema within previously scarred or inflamed nerves. Hyaluronidase may be added to the injectate in an attempt to further the penetration of drugs into the scar tissue.

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 document 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 and Not Medically Necessary:

CPT

 

62263

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

62264

Percutaneous lysis of epidural adhesions using solution injection (eg, hypertonic saline, enzyme) or mechanical means (eg, catheter), including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 1 day

62281

Injection/infusion of neurolytic substance (eg, alcohol, phenol, iced saline solutions), with or without other therapeutic substance; epidural, cervical or thoracic [when specified as injection/infusion for lysis of adhesions]

62282

Injection/infusion of neurolytic substance (eg, alcohol, phenol, iced saline solutions), with or without other therapeutic substance; epidural, lumbar, sacral (caudal) [when specified as injection/infusion for lysis of adhesions]

 

 

ICD-10 Procedure

 

00NW3ZZ

Release cervical spinal cord, percutaneous approach

00NX3ZZ

Release thoracic spinal cord, percutaneous approach

00NY3ZZ

Release lumbar spinal cord, percutaneous approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Chopra P, Smith HS, Deer TR, Bowman RC. Role of adhesiolysis in the management of chronic spinal pain: A systematic review of effectiveness and complications. Pain Physician. 2005; 8:87-100.
  2. Chun-jing H, Hao-xiong N, Jia-xiang N. The application of percutaneous lysis of epidural adhesions in patients with failed back surgery syndrome. Acta Cir Bras. 2012; 27(4):357-362.
  3. 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.
  4. Gerdesmeyer L, Wagenpfeil S, Birkenmaier C, et al. Percutaneous epidural lysis of adhesions in chronic lumbar radicular pain: a randomized, double-blind, placebo-controlled trial. Pain Physician. 2013; 16(3):185-196.
  5. Helm S, Hayek SM, Colson J, et al. Spinal endoscopic adhesiolysis in post lumbar surgery syndrome: an update of assessment of the evidence. Pain Physician. 2013; 16(2 Suppl):SE125-150.
  6. Hong Park C, Ho Lee S. Epidurographic findings following percutaneous epidural adhesiolysis failed to correlate with level of pain reduction in patients with lumbar spinal stenosis. Pain Med. 2017; 18(5):842-845.
  7. 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. 2009a; 12(6):E341-E354.
  8. Manchikanti L, Cash KA, McManus CD, Pampati V. Assessment of effectiveness of percutaneous adhesiolysis in managing chronic low back pain secondary to lumbar central spinal canal stenosis. Int J Med Sci. 2013; 10(1):50-59.
  9. Manchikanti L, Manchikanti KN, Gharibo CG, Kaye AD. Efficacy of percutaneous adhesiolysis in the treatment of lumbar post surgery syndrome. Anesth Pain Med. 2016; 6(2):e26172.
  10. 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):153-166.
  11. 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.
  12. 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. 2009b; 12(6):E355-E368.
  13. Manchikanti L, Singh V, Cash KA, Pampati V. Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial. J Pain Res. 2012; 5:597-608.
  14. Pereira P, Severo M, Monteiro P, et al. Results of lumbar endoscopic adhesiolysis using a radiofrequency catheter in patients with postoperative fibrosis and persistent or recurrent symptoms after discectomy. Pain Pract. 2016; 16(1):67-79.
  15. Racz GB, Heavner JE, Trescot A. Percutaneous lysis of epidural adhesions--evidence for safety and efficacy. Pain Pract. 2008; 8(4):277-286.
  16. Rapcan R, Kocan L, Mláka J. A randomized, multicenter, double-blind, parallel pilot study assessing the effect of mechanical adhesiolysis vs adhesiolysis with corticosteroid and hyaluronidase administration into the epidural space during epiduroscopy. Pain Med. 2018 Mar 23; [Epub ahead of print]. Available at: https://academic.oup.com/painmedicine/advance-article-abstract/doi/10.1093/pm/pnx328/4953041?redirectedFrom=fulltext. Accessed on April 7, 2018.
  17. Takeshima N, Miyakawa H, Okuda K, et al. Evaluation of the therapeutic results of epiduroscopic adhesiolysis for failed back surgery syndrome. Br J Anaesth. 2009; 102(3):400-407. 
  18. Trescot A, 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):129-146.
  19. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. 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):1066-1077.
  2. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013; 16(2 Suppl):S49-283.
Index

Epidural Adhesiolysis
Lysis of Epidural Adhesions
RACZ Neurolysis

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

05/03/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Rationale and References sections were updated.

Reviewed

05/04/2017

MPTAC review. References were updated.

Reviewed

05/05/2016

MPTAC review. The Rationale and References were updated. Removed ICD-9 codes from Coding section.

Reviewed

05/07/2015

MPTAC review. The Rationale and References were updated.

Reviewed

05/15/2014

MPTAC review. Updated Rationale and References. Updated Coding section.

Reviewed

05/09/2013

MPTAC review. Rationale and References updated.

Reviewed

05/10/2012

MPTAC review. Rationale and References updated.

Reviewed

05/19/2011

MPTAC review.

Revised

05/13/2010

MPTAC review. Lysis of epidural adhesions by means of dry catheter manipulation added to investigational and not medically necessary criteria. Title changed. Rationale and References updated.

Reviewed

05/21/2009

MPTAC review. Rationale and References updated.

 

01/01/2009

Updated Coding section with 01/01/2009 CPT changes; removed CPT 0027T deleted 12/31/2008.

Reviewed

05/15/2008

MPTAC review. References updated.

 

02/21/2008

The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

05/17/2007

MPTAC review. Rationale and References updated.

Reviewed

06/08/2006

MPTAC review. References updated.

Revised

07/14/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.  

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

07/27/2004

SURG.00052

Chronic Spine Pain Treatments/Procedures (Minimally Invasive)

WellPoint Health Networks, Inc.

06/24/2004

3.10.06

Lysis of Epidural Adhesions (Using Hypertonic Solutions)