Efficacy of the Electronic Acupuncture Shoes: A Clinical Trial for Chronic Low Back Pain
Status:
Completed
Trial end date:
2012-01-30
Target enrollment:
Participant gender:
Summary
This randomized , double-blind, parallel-arm clinical trial was designed to study the
efficacy and safety of the "Electronic Acupuncture Shoes" treatment on chronic low back pain
patients.
Chronic low back pain patients, aged 20-60, of both gender were recruited. As the primary
outcome measure to assess the efficacy, "0-10 numerical rating scale" was used. Secondary
outcome measure included the speed of pain-relief.
The number of samples in the experimental group and the control group ratio of 1 : 1 , is
expected to total effective sample number is 60 . Experimental group will receive a six-week
"Electronic Acupuncture Shoes" treatment and a week back to the clinic three times , subject
to a total of 18 treatments , each course of about one hour . Subjects will take NSAID
placebo in the first week of the course of treatment . After the second week of NSAID placebo
on disabled.
Control subjects will also accept the six- week treatment , control subjects will be equally
back to the clinic three times a week , each group will be given to the subject of one hour
each shoe pseudo electrotherapy treatment group and control group run by entering from the
test day in the first week of the course , each taking ibuprofen 400mg, taken three times a
day , the second week after the NSAID drugs on disabled.