Abstract
BackgroundAcupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability.Methods/DesignThis study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI) value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID) injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS) of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR). Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.DiscussionThe results of this trial will be discussed.Trial RegistrationClinicalTrial.gov NCT01315561
Highlights
Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique’s efficacy for acute back pain
nonsteroidal anti-inflammatory drug (NSAID) are effective as a short-term treatment for back pain, and are superior to acetaminophen for alleviating pain [11]
There has been growing concern regarding the safety of cyclooxygenase-2 selective NSAIDs for cardiovascular diseases, especially thrombotic diseases such as acute myocardial infarction, instable angina, stroke, and sudden death [14]
Summary
Low back pain is a common symptom that greatly impacts individuals and societies and is experienced by 70-80% of adults at least once in their lives [1]. The common treatment for low back pain is to prescribe painkillers, such as acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs), while encouraging patients to maintain their daily activities [9,10]. NSAIDs are effective as a short-term treatment for back pain, and are superior to acetaminophen for alleviating pain [11]. A systematic review of the literature concluded that acupuncture is effective for pain relief and functional improvement in chronic back pain in the short term, but that, for acute back pain, no evidence of the effectiveness of acupuncture was found [15]. Guidelines for low back pain treatment recommend acupuncture only for chronic back pain [9,10]. This study is designed to examine the effects of MSAT on acute low back pain with severe disabilities
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