Friday, January 18, 2013

Clinical Trial of Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain


Study Protocol for a Randomized, Double-Blinded, Sham-Controlled Trial
Background
Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain.
Methods
This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and >=4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck's Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks.
Discussion
The results from this study will provide clinical evidence on the efficacy and safety of bee venom acupuncture in patients with chronic non-specific low back pain.

3 comments:

Unknown said...

How does one become a subject for this trial or is it full?
Pamela Hammond
49 Bonds Rd.
Ohatchee, AL 36271
256 454-7659

Phamm54@gmail.com

Unknown said...

How does one become a subject for this trial or is it full?

I have had chronic Low back pain since my teens & I would love to see if this would help

I am a beginning beekeeper & VERY interested in apitherapy; especially BVT.

Pamela Hammond
49 Bonds Rd
Ohatchee, AL 36271
256 454-7659

Phamm54@gmail.com

Anonymous said...

New Research Shows Acupuncture More Effective for Low Back Pain Than Conventional Treatment.

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