Spinal endoscopic adhesiolysis in the management of chronic low back pain: a preliminary report of a randomized, double-blind trial.

Epidural adhesiolysis with spinal endoscopy is an emerging interventional pain management technique in managing chronic refractory low back and lower extremity pain. However, there is a lack of significant data demonstrating the effectiveness of spinal endoscopic adhesiolysis. This randomized, double-blind controlled trial was undertaken to determine the ability of spinal endoscopic adhesiolysis to reduce pain and improve functional and psychological status. The study was performed in an interventional pain management practice, a specialty referral center, in a private practice setting. This trial extended from January 2002 to December 2002. However, only the patients with 6-month follow-up were included. Any relief of less than 6 months was considered as short-term and 6-months or longer was considered as long-term. All the patients with chronic low back pain of at least 6 months and having failed conservative modalities of management, including fluoroscopically directed epidural steroid injections and percutaneous adhesiolysis, were included. Patient assignment was by randomized selection from all eligible subjects. Two types of interventions were included with Group I serving as the control with endoscopy to the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II consisted of spinal endoscopy and appropriate adhesiolysis, followed by injection of local anesthetic and steroid. Outcome measures were focused to evaluate and demonstrate a clinically significant difference between the treated patients and those patients randomized to the control group in multiple parameters of pain, functional status, psychological, and behavioral status. Overall, 13 of 23 patients (57%) showed significant improvement without adverse events. Based on the definition that less than 6 months of relief is considered as short-term and longer than 6 months is considered as long-term, a significant number of patients obtained long-term relief. The results showed significant improvement in patients undergoing spinal endoscopic adhesiolysis at 1-month, 3-months, and 6-months, compared to baseline measurements, as well as compared to the control group without adhesiolysis. Spinal endoscopic adhesiolysis with targeted injection of local anesthetic and steroid, is an effective treatment in a significant number of patients without major adverse effects at 6-month follow-up.

RCT Entities:   Population Interventions Outcomes