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

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ClinicalTrials.gov Identifier: NCT02468297
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Chen Yu Sheng, Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Device: Electronic Acupunture Shoes Drug: Ibuprofen Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Electronic Acupuncture Shoes: A Clinical Trial for Chronic Low Back Pain
Actual Study Start Date : April 15, 2009
Actual Primary Completion Date : January 30, 2012
Actual Study Completion Date : January 30, 2012

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Pain score [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. The speed of pain-relief [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .


Responsible Party: Chen Yu Sheng, Medical Doctor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02468297     History of Changes
Other Study ID Numbers: 92-0530A
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action