[ISRCTN 16558617] A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain

Laxmaiah Manchikanti, Mark V Boswell, Jose J Rivera, Vidya Sagar Pampati, Kim S Damron, Carla D McManus, Doris E Brandon, Sue R Wilson, Laxmaiah Manchikanti, Mark V Boswell, Jose J Rivera, Vidya Sagar Pampati, Kim S Damron, Carla D McManus, Doris E Brandon, Sue R Wilson

Abstract

Background: Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described.

Methods: A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid.

Results: Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status.

Conclusion: Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects.

Figures

Figure 1
Figure 1
Schematic depiction of patient flow during the trial.
Figure 2
Figure 2
Outcome measurement based on Visual Analogue Scale report.
Figure 3
Figure 3
Proportion of patients with significant relief (≥ 50%) at 1 month, 3 months, 6 months and 12 months.
Figure 4
Figure 4
The Outcome Measurement Based on Oswestry Disability Index.

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