Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study)

Abstract Background Persistent pain following back surgery called failed back surgery syndrome remains a major treatment challenge. The aim of this study is to evaluate the efficacy and safety of electroacupuncture on relieving back pain in FBSS patients. Methods/design This is a randomized, single-blind, single-site, placebo-controlled trial. A total of 144 eligible FBSS patients will be randomly assigned to the electroacupuncture, manual acupuncture, or sham acupuncture group in a 1:1:1 ratio. Each group will receive 2 treatment sessions per week for 12 weeks. The primary outcome will be low back pain intensity based on the 11-point numerical rating scale (NRS). The secondary outcomes include Oswestry Disability Index (ODI) questionnaire, Beck Depression Inventory-II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), and analgesic consumption. All clinical outcomes will be collected at baseline, during the treatment phase (at 8 and 12 weeks), and at the 16-, 24- and 36-week follow-ups. All data will be analyzed based on the intention-to-treat principle and adverse events will be assessed during the trial. Discussion This pilot randomized controlled trial will evaluate the efficacy of electroacupuncture for treating failed back surgery syndrome. The outcomes will determine whether electroacupuncture is efficacious in relieving low back pain as well as improving the quality of life in failed back surgery syndrome patients. Trial registration Chinese Clinical Trial Registry ChiCTR2000040144. Registered on 22 November 2020

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Spinal Cord Stimulation Electrode Design: A Prospective, Randomized, Controlled Trial Comparing Percutaneous with Laminectomy Electrodes: Part II–Clinical Outcomes

Neurosurgery ◽

10.1227/01.neu.0000180030.00167.b9 ◽

2005 ◽

Vol 57 (5) ◽

pp. 990-996 ◽

Cited By ~ 93

Author(s):

Richard B. North ◽

David H. Kidd ◽

Loredana Petrucci ◽

Michael J. Dorsi

Keyword(s):

Spinal Cord ◽

Controlled Trial ◽

Clinical Results ◽

Failed Back Surgery Syndrome ◽

Electrode Placement ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Failed Back Surgery ◽

Back Surgery

Abstract OBJECTIVE: Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients. METHODS: Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined “success” as at least 50% sustained relief of pain and patient satisfaction with the result of treatment. RESULTS: At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed. CONCLUSION: Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.

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