A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; p. 65
• Main Authors: Shin, Byung-Cheul, Cho, Jae-Heung, Ha, In-Hyuk, Heo, In, Lee, Jun-Hwan, Kim, Koh-Woon, Kim, Me-Riong, Jung, So-Young, Kwon, Ojin, Kim, Nam-Kwen, Son, Haeng-Mi, Son, Dong-Wuk, Shin, Kyung-Min
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 24.01.2018; BioMed Central; BMC
• Subjects: Acupuncture; Adult; Aged; Analysis; Arthritis; Back pain; Back surgery; Cardiovascular disease; Care and treatment; Chronic illnesses; Clinical medicine; Clinical practice guidelines; Clinical trials; Comparative analysis; Complications and side effects; Cost analysis; Cost-Benefit Analysis; Diabetic neuropathy; Disability Evaluation; Economic aspects; Electroacupuncture; Electroacupuncture - adverse effects; Electroacupuncture - economics; Female; Health aspects; Health Care Costs; Hospitals; Humans; Informed consent; Integrative medicine; Low back pain; Low Back Pain - diagnosis; Low Back Pain - economics; Low Back Pain - etiology; Low Back Pain - therapy; Male; Medical research; Middle Aged; Multicenter Studies as Topic; Narcotics; Pain; Pain management; Pain Measurement; Pain, Postoperative - diagnosis; Pain, Postoperative - economics; Pain, Postoperative - etiology; Pain, Postoperative - therapy; Participation; Patient outcomes; Postoperative pain; Qualitative Research; Randomized controlled trial; Randomized Controlled Trials as Topic; Recovery of Function; Republic of Korea; Spinal surgery; Study Protocol; Systematic review; Time Factors; Treatment Outcome; Young Adult; Republic of Korea; South Korea; Back surgery; Postoperative pain; Electroacupuncture; Randomized controlled trial; Low back pain; Integrative medicine
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2461-6

Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.