Comparing Acupuncture, BioModulator, and Transcutaneous Electrical Nerve Stimulation for Symptomatic Treatment of Chronic Pain.

May 18, 2015 updated by: Samueli Institute for Information Biology

A Randomized Study Comparing the Tennant BioModulator to Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the Symptomatic Treatment of Chronic Pain Among Injured Service Members.

The primary objective of this preliminary study is to compare the Tennant BioModulator with Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the management of chronic pain among injured service members. The secondary objective is to investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder (PTSD) symptoms, or depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be Injured service members between the ages of 18 and 60, inclusive;
  • The pain must have been present for 3 months or greater prior to entry into the study;
  • Subjects must agree to follow the medication regime as directed by the pain clinic provider for the duration of the study;
  • Subjects must be able to speak and read English and understand study procedures

Exclusion Criteria:

  • Epilepsy
  • Pregnancy, or considering pregnancy within the study time-frame
  • Pacemaker
  • History of cardiac arrhythmias
  • Implantable devices (AICD, pump, etc.)
  • Surgical intervention during the past month for the treatment of low back pain or its underlying etiology
  • Documented history of prescription medication abuse
  • Abuse of illicit drugs within the last 6 months
  • Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupuncture Treatment
Traditional Chinese acupuncture.
Other: Traditional Chinese Acupuncture
Treatment will be performed by an experienced provider, and may include insertion of sterile 32-gage (0.25mm) acupuncture needles on any part of the body that can be needled while the subject is lying prone with their head in a face cradle. The needles are usually retained for 20-30 minutes along various meridian points identified by the practitioner as being "blocked." Needles will be inserted to the depth typically recommended for the particular point of concern; generally 1 to 3cm. There are no constraints on the number of needles used. Acupuncture points are points of lower resistance and higher electrical conductance than the surrounding tissue. Placing the acupuncture needles into points identified as blocked is believed to help restore the flow of energy and stimulates the release of endorphins. The subject's level of pain is assessed on a 0-10 pain scale. Thirty minute acupuncture treatments will be given by the provider once a week for 6 weeks at the pain clinic.
Active Comparator: Tennant™ Biomodulator Treatment
Device: Tennant™ Biomodulator Treatment
An FDA-approved Tennant™ 650 BioModulator will be used to deliver electrical stimulation. The device will be applied directly on top of the subject's area of pain for one minute; power is adjusted until the subject feels a slight tingle. Random variations of pulse amplitude are set from zero to a chosen comfort limit. A feedback mechanism is provided by the constant monitoring of skin impedance. The device is then pressed onto the site of pain and rotated counter-clockwise. After a minute, the device is placed on the opposite side of the pain site and the procedure repeated. The subject's level of pain is assessed on a 0-10 pain scale. At no time is the level of electrical stimulation allowed to cause sustained pain. The subject will receive a weekly 15 minute visit that includes a treatment provided by the pain provider. The provider will teach the subject how to use the machine by themselves and instruct the subject to use the machine twice a day on their own during the study.
Active Comparator: Transcutaneous electrical nerve stimulation (TENS) Treatment
Device: Transcutaneous electrical nerve stimulation (TENS) Treatment
An FDA-approved Empi™ TENS unit will be used to deliver the transcutaneous electrical nerve stimulation. The low frequency TENS unit will be applied to the subject's area of pain by the use of four integrated self-adhering 5x5 cm electrodes. The electrodes will be positioned at a distance of 3 cm and centered over the area that is most painful. The device rapidly delivers therapeutic electrical currents at various frequencies off and on 150 times a second. The subject's level of pain is assessed on a 0-10 pain scale. At no time is the level of electrical stimulation allowed to cause sustained pain. The subject will receive a weekly 15 minute visit that includes a treatment provided by the pain provider. The provider will teach the subject how to use the machine by themselves and instruct the subject to use the machine twice a day on their own during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chronic pain
Time Frame: Baseline; post-intervention; one-month follow up.
Baseline; post-intervention; one-month follow up.

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression, PTSD symptoms, Sleep.
Time Frame: Baseline; post-intervention; one-month follow up.
Baseline; post-intervention; one-month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samueli Institute for Information Biology

Investigators

  • Principal Investigator: Michael Schlicher, PhD, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 18, 2012

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2009.098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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