A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial.

BACKGROUND Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, and facet joint pain among other causes. Even though fluoroscopically directed caudal epidural injections and facet joint interventions are effective in some patients, others continue to suffer with chronic persistent pain. Percutaneous adhesiolysis with target delivery of medications has been demonstrated to be effective in these patients. However, the evidence for percutaneous adhesiolysis in managing post surgery syndrome has been questioned, coupled with a paucity of controlled trials. STUDY DESIGN A randomized, equivalence, controlled trial. SETTING An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVES To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain in post surgery syndrome and compare with fluoroscopically directed caudal epidural steroid injections. METHODS Patients were randomly assigned to one of 2 groups: Group I (60 patients) receiving caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution serving as the control group, and Group II (60 patients) receiving percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate Betamethasone serving as the intervention group. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months post treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more. RESULTS Significant pain relief (>or= 50%) and functional status improvement was recorded in 73% of patients in Group II versus 12% in Group I (P < 0.001). The average procedures per year were 3.5 with an average total relief of 42 out of 52 weeks in Group II and 2.2 procedures with total relief per year of 13 weeks in Group I (P < 0.001). LIMITATIONS The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group, and the preliminary report of one-year follow-up. CONCLUSIONS Percutaneous adhesiolysis in chronic function-limiting, recalcitrant low back pain in post lumbar surgery syndrome demonstrated effectiveness in 73% of the patients.