Subcutaneous Stimulation as ADD-ON Therapy to Spinal Cord Stimulation Is Effective in Treating Low Back Pain in Patients With Failed Back Surgery Syndrome: A Multicenter Randomized Controlled Trial

2016 ◽  
Vol 19 (2) ◽  
pp. 171-178 ◽  
Author(s):  
Eric-Jan J.A.A. van Gorp ◽  
Onno P.M. Teernstra ◽  
Ismail Gültuna ◽  
Tanja Hamm-Faber ◽  
Katja Bürger ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Controlled Trial ◽  
Failed Back Surgery Syndrome ◽  
Low Back ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Failed Back Surgery ◽  
Back Surgery

scholarly journals Efficacy of electroacupuncture in patients with failed back surgery syndrome: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiaoping Sheng ◽  
Hongyu Yue ◽  
Qi Zhang ◽  
Deta Chen ◽  
Weidong Qiu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Failed Back Surgery Syndrome ◽  
Low Back ◽  
Randomized Controlled ◽  
Failed Back Surgery ◽  
Back Surgery

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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