Lysis of Epidural Adhesions

Coding 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; 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; 1 day


BACKGROUND
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.
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.
Epidural fibrosis and adhesive arachnoiditis 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, 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 (also known as the Racz procedure), using fluoroscopic guidance, with epidural injections of hypertonic saline in conjunction with steroids 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, adhesions may be disrupted by manipulating the catheter at the time of the injection.Spinal endoscopy has been used to guide the lysis procedure.Prior to 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.

EVIDENCE SUMMARY
Evidence from large, well-designed randomized controlled trials (RCTs) with adequate duration of follow-up are necessary in order to demonstrate the safety and effectiveness of lysis of epidural adhesions.

Systematic Reviews
A systematic review by Brito-Garcia (2019) assessed the efficacy, effectiveness, safety, and cost-effectiveness of epidural adhesiolysis for the treatment of failed back surgery syndrome. [1]en articles were included in the review, three of which reported on two RCTs (described below), and seven observational studies.No studies were found that evaluated efficacy or cost-effectiveness.While the included studies suggested that adhesiolysis may be effective for treating back pain and disability, the authors noted that the published RCTs had serious limitations in their methodology and substantial risk of bias.
Cho (2017) published a systematic review that evaluated several treatment options for failed back surgery syndrome (FBSS). [2]Five studies were evaluated specifically for epidural adhesiolysis (two RCTs, two systematic reviews, and one observational study).The authors concluded epidural adhesiolysis can be effective in treating chronic pain from FBSS based on the two excellent quality RCTs.Although, it's important to note that none of the studies evaluated long-term outcomes, the quality of the systematic reviews was noted to be I, II-1 or fair according to the US Preventive Services Task Force (USPSTF) criteria and more research is needed to support the evidence.

Randomized Control Trials
No RCTS were identified that were published since the above systematic review.

Nonrandomized Studies
Kim (2023) published a retrospective study examining patients who had low back pain and who had underwent lumbar epidural adhesiolysis between 2012-2021 [3] .Participants were followed for at least six months with check-ins at one, three, and six months.Of the 169 participants enrolled, 77 patients (~45%) reported clinically meaningful pain relief (defined as >30% pain reduction at six month follow-up), and 92 patients (~54%) reported poor pain relief following the procedure.The majority of patients who had a longer pain duration (>3 years) prior to the procedure reported poor pain relief six months following the procedure (~81%).This study is limited by its retrospective design in a single center, and these findings do not support the use of epidural adhesiolysis as most patients had poor pain relief following the procedure.

Randomized Controlled Trials (RCTs)
Gerdesmeyer (2013) randomized 381 patients with chronic radicular pain lasting longer than four months which failed to respond with conservative therapy using a prospective study design. [4]Patients were randomly assigned to receive either percutaneous neurolysis or placebo with concealed allocation in permuted blocks of four to eight, stratified by treatment center.The primary outcome measure was the differences in percent change of Oswestry Disability Index (ODI) scores three months after intervention.However, limitations of the study included single treatment components could not be specified because there was no imaging examination after treatment.
A 10-year follow-up to the Gerdesmeyer study described above was published to determine if the difference in outcomes remained between the treatment and control groups. [5]Results from the follow-up showed that ODI in the lysis group improved from 55.3 ± 11.6 to 9.6 ± 9.3 after one year and to 11.7 ± 14.2 after 10 years.The placebo group also improved from 55.4 ± 11.5 to 30.7 ± 14.2 after one year and to 24.8 ± 12.0 after 10 years.Additionally, VAS improved from 6.7 ± 1.1 to 1.2 ± 1.1 after one year and to 1.5 ± 1.4 after 10 years in the lysis group and from 6.7 ± 1.1 to 2.8 ± 1.5 after one year and to 2.9 ± 1.3 after 10 years after placebo intervention.The authors concluded that the statistical difference for ODI and VAS remained significant for up to 10 years between the treatment groups.No treatment-related severe adverse effects occurred within the 10 years, but minor transient neurological effects were seen directly after the intervention.This follow-up study is limited based on no-follow up imaging evaluation and uncontrolled for the large variety of noninvasive treatments done during the follow-up period.
Two comparative effectiveness RCTs by Manchikanti (2009) [6,7] report one-year outcomes.Patients in one trial had failed back surgery syndrome (planned enrollment, 200 patients), and patients in the other had chronic low back pain secondary to spinal stenosis (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.After all procedures were performed, patients received an 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, injection of lidocaine, and and injection of normal saline and betamethasone.For the patients with failed back surgery, significant pain relief (defined as >50% reduction in VAS score) was achieved by 73% of patients in the lysis group compared with 12% in the control group (p<0.001).For patients with spinal stenosis, there were no outcomes reported at the time of publication.
In the two-year follow-up report on this study, Manchikanti (2012) reported 82% of patients receiving adhesiolysis had significant improvement in functional status and relief of pain of at least 50% compared to only 5% improvement in the epidural corticosteroid injection group. [8]f patients had improved functioning and pain reductions of at least 50% after at least three months following adhesiolysis, repeat adhesiolysis was permitted.Patients in the adhesiolysis group received an average of 6.4 adhesiolysis procedures while patients in the epidural corticosteroid injection group averaged 2.4 procedures over the two-year period.
A number of limitations are apparent in the studies.Losses to follow-up in the control groups were large in both studies (10 of 60 at six months and 43 of 60 at 12 months in the failed back surgery study, and 10 of 25 at six months and 18 of 25 at 12 months in the spinal stenosis study).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.Physicians performing procedures could not be blinded to treatment group but did not know which patients were participating in the studies.Manchikanti (2004) published the results of a trial that randomized 75 patients to one of three groups, either a control group consisting of catheterization without adhesiolysis, or to adhesiolysis with or without additional hypertonic saline. [9]All patients received epidural injections of local anesthetic and steroids.Significant differences in pain relief, ODI scores, and range of motion were noted between the two treatment groups and the control group.In another trial, Manchikanti (2001) randomized 45 patients to a one-or a three-day course of lysis of epidural adhesions. [10]A total of 97% of the treatment group with one to three injections reported at least 50% pain relief at three months, which fell to 93% at six months, and to 47% at one year.There were no significant improvements in the control group.Manchikanti (2023) published a systematic review and examined nine randomized controlled trials investigating the efficacy of percutaneous adhesiolysis in managing low back pain between 1966-2022 [11] .Researchers examined pain level following procedure, functionality using the Oswestry Disability Index (ODI), Opioid consumption, at three, six, and twelve months.Pain level at three, six, and twelve months was statistically different compared to control in all but one study.Functionality was also significantly different compared to control at three, six, and twelve in all but two studies.Opioid consumption between control and treatment was statistically significant in 2/9 studies at three months, 3/9 studies at six months, and 3/9 studies at 12 months.Overall, the authors suggest that percutaneous adhesiolysis is effective in managing low back pain, however the findings are significantly limited.This analysis only includes symptom reporting up to twelve months, and does not include any long-term side effects possibly associated with this procedure.Additionally, the majority of these studies include a relatively small sample size ranging from 25-120 patients.4]

Nonrandomized Studies
Serious adverse events from epidural lysis have been reported. [15]Manchikanti (2012) reported on 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. [16]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 Systematic Reviews
Helm (2012) evaluated the effectiveness of percutaneous adhesiolysis in the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis.The severity of risks and adverse advents associated with percutaneous adhesiolysis were also evaluated. [17]Authors applied the U.S. Preventive Services Task Force (USPSTF) criteria to the 15 studies identified and selected for review.Authors 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.
In an update of the review described above, Helm (2013) evaluated endoscopic adhesiolysis. [18]The authors included one RCT and three observational studies in the review and noted there is a limited amount of literature available on endoscopic adhesiolysis.Despite limitations in available evidence, using USPSTF quality of evidence criteria, the authors concluded there is fair evidence that spinal endoscopic adhesiolysis is effective in reducing chronic low back and/or leg pain in post lumbar surgery syndrome in both the short and long term (>12 months).

Randomized Controlled Trials (RCTs)
Two RCTs by Manchikanti were included in the systematic reviews previously described.One 2003 double-blinded trial randomized 23 patients with back pain of greater than six months' duration to receive either spinal endoscopy followed by injection of local anesthetic or steroid (control group) or the above procedure with the addition of lysis of adhesions with normal saline and mechanical disruption with the fiberoptic endoscope. [19]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 six months.In the control group the mean VAS score dropped from 8.7 at baseline to 7.6 at six months, while the scores in the intervention group dropped from 9.2 at baseline to 5.7 at six months.The difference between the control and intervention group was statistically significant.There was also a significant difference between the two groups in the percentage of patients experiencing at least a 50% reduction in pain.Blinding appeared to be successful as six of the 16 patients in the control group believed that they were in the intervention group, and eight 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 reliability of the findings.
In the second study, Manchikanti (2005) reported results of a randomized trial of endoscopic adhesiolysis compared to caudal epidural steroid injection. [20]Again, the independent contribution of the adhesiolysis cannot be assessed as targeted injections of both local anesthetic and steroids were given to the intervention group.In addition, a true comparison between treatment and control groups cannot be made as the control group received local anesthetic and steroid injections at S3, whereas the intervention group received targeted injections following adhesiolysis at the level of suspected pathology (L4, L5, and S1).Other methodologic issues limiting reliability interpretation of the study outcomes include the introduction of bias as a result of 2:3 randomization (patients entered the study believing they had a higher chance of being included in the treatment group) and the unblinding of some patients at three months, although an intent-to-treat analysis was performed.

Nonrandomized Studies
Nonrandomized studies have evaluated lumbar endoscopic adhesiolysis following discectomy, but the studies have significant limitations, including small sample size and lack of controls. [21]4][25]

SUMMARY OF EVIDENCE
For individuals who have epidural adhesions who receive lysis, the evidence includes randomized controlled trials.Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.Several randomized controlled trials have reported benefits for epidural lysis of adhesions compared with placebo treatment.Many of these trials were conducted at the same center.The interpretation of these trials is limited by differences in patients, populations, and treatment protocols.The treatment for lysis of adhesions varied in the use of mechanical disruption, the type of lytic medications used, and the number of injections given.There was also a large effect in the placebo group, raising questions whether some component of the placebo treatment may be therapeutic.Larger trials with standardized treatment protocols would help determine whether specific treatment protocols have beneficial effects in specific patient populations.The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINE SUMMARY AMERICAN SOCIETY OF INTERVENTIONAL PAIN PHYSICIANS (ASIPP)
The ASIPP updated their practice guidelines on the management of chronic spinal pain in 2021. [26]The updated 2021 guidelines included the following statements regarding percutaneous adhesiolysis.
1. "The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality randomized control trial is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections." 2. "The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant randomized controlled trials, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long term improvement after failure of conservative management and fluoroscopically guided injections." 3. "For percutaneous adhesiolysis, based on multiple moderate randomized controlled trials and systematic reviews, the guidance is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidureal injections.
The previous guideline from 2013 [27] more broadly stated that, "for lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis."It further states that "due to limited evidence and rate use of spinal epidural endoscopic adhesiolysis, it is not discussed."The studies supporting the guideline recommendations have been reviewed in this policy.

AMERICAN PAIN SOCIETY (APS)
The APS 2009 evidence-based clinical practice guideline on interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain, does not include a specific discussion or conclusion on adhesiolysis; however, the guideline states that, "for other interventions or specific clinical circumstances, the panel found insufficient evidence from randomized controlled trials to reliably judge benefits or harms." [28]

SUMMARY
There is not enough research to show that catheter-based techniques for lysis of epidural adhesions, with or without endoscopic guidance improves health outcomes.No clinical guidelines based on research recommend these techniques.Therefore, lysis of epidural adhesions, with or without endoscopic guidance, is considered investigational.