Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

Abstract

BackgroundChronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP.Methods/DesignThis is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be analyzed.DiscussionOur study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients.Trial registrationThis study is registered with the United States (US) National Institutes of Health Clinical Trials Registry: NCT01922466.

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“…However, the authors highlighted that not only was the total human sample size too small, but the quality of experimental design was varied and sometimes inadequate. Recently, two pilot studies addressing chronic pain of the neck and lower back have were designed under a rigorous randomized clinical trial with the aim to evaluate the true effect of bee venom acupuncture [ 36 , 37 ]. Therefore, new protocolized studies are in the pipeline to validate the efficiency of this novel therapy.…”

Clinical Applications of Bee Venom Acupoint Injection

“…More and more people are affected by chronic neck pain or lower back pain. These patients are often prescribed NSAIDs [ 80 ] or alternative treatments such as BVA [ 81 , 82 ]. In one recent blinded human trial, 54 people suffering from chronic lower back pain were assigned to either BVA or sham acupuncture groups.…”

Efficacy of Pulsed Electromagnetic Field on Pain and Function in Chronic Mechanical Neck Pain: A Randomized Controlled Trial

“…In addition to psychosocial stress, the existence of mechanical factors like prolonged use of computers, maintaining faulty posture for prolonged time and repetitive movements may contribute to the development of chronic MNP [10,11]. The treatment of chronic MNP includes pharmacological [12] and non-pharmacological interventions. The non-pharmacological treatment may include manual therapy [13], massage [14] and neck exercises [13].…”