title: Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial.
abstract: BACKGROUND
  Chronic 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
  This 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.
  
  
  CONCLUSIONS
  Our 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.
  
  
  BACKGROUND
  This study is registered with the United States (US) National Institutes of Health Clinical Trials Registry: NCT01922466.
authors.forename: Byung-Kwan
authors.initials: BK
authors.lastname: Seo
authors.forename: Jun-Hwan
authors.initials: JH
authors.lastname: Lee
authors.forename: Pil-Kun
authors.initials: PK
authors.lastname: Kim
authors.forename: Yong-Hyeon
authors.initials: YH
authors.lastname: Baek
authors.forename: Dae-Jean
authors.initials: DJ
authors.lastname: Jo
authors.affiliation: Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 305-811, Republic of Korea. ezhani@kiom.re.kr.
authors.forename: Sanghun
authors.initials: S
authors.lastname: Lee
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects / Q000379:methods*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001514:Bee Venoms / Q000008:administration & dosage* / Q000009:adverse effects; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019547:Neck Pain / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D010147:Pain Measurement; D010666:Phenylpropionates / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001514:Bee Venoms; D010666:Phenylpropionates; C040656:loxoprofen
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