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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Electronic Acupunture Shoes; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electronic Acupuncture Shoe; 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; 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.
PLACEBO_COMPARATOR: Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain score	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chen Yu Sheng

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2009
• Primary Completion (ACTUAL): January 30, 2012
• Study Completion (ACTUAL): January 30, 2012

Study Registration Dates

• First Submitted: June 6, 2015
• First Submitted That Met QC Criteria: June 7, 2015
• First Posted (ESTIMATE): June 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 92-0530A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO