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Completed

NCT Number: NCT02468297

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Electronic Acupunture Shoes

Device

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.

Ibuprofen

Drug

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.

Primary outcomes

  1. Pain score

    Time frame: 6 weeks

Secondary outcomes

  1. The speed of pain-relief

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Chen Yu Sheng

Other

Registry information

Acronym: EAS

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2015
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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