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

NCT02468297 | Completed

• 1 other identifier: 92-0530A
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  6 weeks

Secondary Outcomes (1)

• The speed of pain-relief

  6 weeks

Study Arms (2)

Electronic Acupuncture Shoe

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

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.

Electronic Acupuncture Shoe

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.

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Chen Yu Sheng: lead

Related Publications (1)

• Yeh BY, Liu GH, Lee TY, Wong AM, Chang HH, Chen YS. Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial. J Med Internet Res. 2020 Oct 26;22(10):e22324. doi: 10.2196/22324.

  PMID: 33104004 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 6, 2015
• First Posted: June 10, 2015
• Study Start: April 15, 2009
• Primary Completion: January 30, 2012
• Study Completion: January 30, 2012
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share