Efficacy of the Electronic Acupuncture Shoes: A Clinical Trial for Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of the Electronic Acupuncture Shoes: A Clinical Trial for Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Electronic Acupunture Shoes
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Diagnosed with chronic low back pain (pain that persists for more than 12 weeks ). B. Subjects who agreed to be involved and signed the agreement, after being explained to by the investigators. Exclusion Criteria: A. Diagnosed with cancer . B. Early menopause ( before age 50 ) . C. Ovariectomized D. Under steroid therapy E. Rheumatoid arthritis F. With fractures or have undergone back surgery. G. Compression syndrome: e.g. HIVD ( Herniated Intervertebral Disc) , spinal disorder . H. Renal calculus. I. Pacemaker users . J. Pregnant women or women who expect to be pregnant. K. Visual impairment . L. Diabetes. M. Visceral infections, e.g. pancreatitis, nephritis . N. Under other clinical trials (under medication or given other treatment) within 30 days before . O. Contraindications of ibuprofen. P. Poor function of heart, liver, GI tract or kidney. Q. Be suspected by the doctors of potential illness, disease or any other reason, which may endanger the subjects .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Acupuncture Shoe<br>Experiment group receives a one-hour treatment given by Electronic Acupuncture Shoe three times a week. 6 weeks of treatment was given. Subjects took placebo only in the first week. No placebo or medicine was prescribed to the subjects since the second week. | Device: Electronic Acupunture Shoes<br>* Experiment group receives a one-hour treatment given by Electronic Acupuncture Shoes three times a week. 6 weeks of treatment was given. Control group received the six-week treatment as well, yet the subjects received pseudo electrotherapy.<br>|
| Placebo Comparator: Control group<br>Control group received the six-week treatment as well, yet the subjects received pseudo electrotherapy. Subjects took ibuprofen(400mg, TID) only in the first week. No placebo or medicine was prescribed to the subjects since the second week. | Drug: Ibuprofen<br>* Experiment group took placebo only in the first week. Control group took ibuprofen(400mg, TID) only in the first week. No more placebo or medicine was prescribed to either two groups since the second week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The speed of pain-relief |  | 6 weeks |