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Table 1 Bee venom acupuncture treatment and sham treatment protocol

From: Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

  Item Details
1. Acupuncture rationale (a) Style of acupuncture Traditional Korean medicine theory
(b) Reasoning for treatment provided (based on historical context, literature sources and consensus methods) Textbook on acupuncture and moxibustion-related articles (published trials) [14]
(c) Extent to which treatment was varied Within 10 predefined acupoints
2. Details of needling (a) Number of needle insertions per patient per session Within 10 acupoints
(b) Names (or location if no standard name) of points used (uni/bilateral) Shenshu (BL23), Qihaishu (BL24), Dachangshu (BL25), Huantiao (GB30), Yaoyangguan (GV3), Mingmen (GV4), Xuanshu (GV5)
(c) Depth of insertion 5 to 10 mm (subcutaneous)
(d) Response sought (for example, de qi or muscle twitch response) Penetrating, sharp, aching and painful sensations when penetrating the skin. Spreading and lumpish sensation around the injection site. Skin stimulation by bee venom in BVA group.
(e) Needle stimulation (for example, manual, electrical) Pharmacopuncture
(f) Needle-retention time None
(g) Needle type (diameter, length and manufacturer or material) 1.0 ml disposable syringe (26-gauge needle) produced by Green Cross Medical Equipment (Seoul, Korea)
3. Treatment regimen (a) Number of treatment sessions Six
(b) Frequency and duration of treatment sessions Twice a week for three weeks
4. Other components of treatment (a) Details of other interventions administered to the acupuncture group Brochure with information about chronic low back pain, lifestyle advice
(b) Setting and context of treatment, including instructions to practitioners and information and explanations to patients Independent researcher counseling regarding treatment, lifestyle management of low back pain
5. Practitioner background (a) Description of participating acupuncturists Korean medical doctors who are specialists of acupuncture and moxibustion or oriental rehabilitation medicine, with more than three years of clinical experience under supervision by a specialist
6. Control or comparator interventions (a) Rationale for the control or comparator in the context of the research question with sources that justify this choice See [15]
See [16]
See [17]
(b) Precise description of the control or comparator if sham acupuncture Double blind: In the sham BVA group, normal saline was used instead of BVA. Both real and sham BVA were subcutaneously injected into predefined acupoints through identical manipulation techniques and the assessor, acupuncturist and patients were uninformed about allocation.
Explanations given to patients: Explanation of real or sham BVA was given to patients before randomization.
Details of sham BVA: Acupuncture points used, needle type, depths of insertion, responses, needle stimulation and needle retention time were identical in each group. The only difference was that normal saline was used for injection.
Injection and increment protocol: The BVA group was prepared by a predefined weekly increment protocol as follows: 0.2 ml for the first week, 0.4 ml for the second week and 0.8 ml for the third week. The sham BVA group was injected with normal saline at the same volume as the BVA group. The predefined points were carefully selected by a process of consensus with the participating Korean medical doctor.
  1. BVA: bee venom acupuncture.