Abstract
BackgroundAlthough 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.Methods/designThis 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.DiscussionThe 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.Trial registrationClinical Research Information Service (CRIS), Republic of Korea, KCT0001939. Registered on 8 June 2016.
Highlights
Pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians
EA is a common treatment for pain management [19, 20], including myofascial pain [21], osteoarthritis of the knee [22], chronic shoulder and neck pain [23], and Low back pain (LBP) [24]
EA is a common treatment for pain management and has shown a greater analgesic effect than placebo; reductions in non-specific LBP scores using a 100-point scale were > 20 points greater in EA than in placebo [42]
Summary
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. While lumbar spine surgery methods such as discectomy and spinal fusion continue to increase in popularity, [6] various complications may occur following back surgery, possibly resulting in worse conditions [7]. Opioids may cause various side effects ranging from itching and sedation to nausea [12]; effective and safe pain management after back surgery is warranted
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