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) 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. (3) 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 U.S. Preventive Services Task Force (USPSTF) criteria. (4) Epter with Hayek and others concluded that there is level-I or -II evidence (3 randomized trials and 4 observational studies) for percutaneous adhesiolysis. (5) The studies cited in the reviews were reviewed individually for this policy (see following sections).
The evidence for lysis of epidural adhesions consists of single-center studies, most of them from a single U.S. pain management group.
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. (6) 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.
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. (7) 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. The lack of a placebo control and 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. (8)
Percutaneous Lysis of Adhesions with Spinal Endoscopy
One small randomized, controlled trial was identified in 2003 by Manchikanti and colleagues. Twenty-three patients with back pain of greater than 6 monthsâ€™ 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. (9) 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.
Two 2009 papers by Manchikanti and colleagues (10, 11) report 1-year outcomes of 2 comparative effectiveness 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 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.
A randomized single-blinded trial compared epidural lysis with physiotherapy in 99 patients with chronic low back pain. (13) 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.
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. (14) 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.
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. (15, 16) As these articles are authored by the same investigator, it is likely that they include overlapping patients. These studies did not include a control group.
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.
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. (18) The guideline states that â€œevidence 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.â€ It further states that â€œthe 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.â€ 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 â€œfor other interventions or specific clinical circumstances, the panel found insufficient evidence from randomized controlled trials to reliably judge benefits or harms.â€ (19)
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