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

This study is currently recruiting participants.
Verified August 2013 by Samueli Institute for Information Biology
Sponsor:
Information provided by (Responsible Party):
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT01752010
First received: December 14, 2012
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Chronic Pain
Depression
PTSD Symptoms
Sleep
Other: Traditional Chinese Acupuncture
Device: Tennant™ Biomodulator Treatment
Device: Transcutaneous electrical nerve stimulation (TENS) Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Samueli Institute for Information Biology:

Primary Outcome Measures:
  • Chronic pain [ Time Frame: Baseline; post-intervention; one-month follow up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression, PTSD symptoms, Sleep. [ Time Frame: Baseline; post-intervention; one-month follow up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752010

Contacts
Contact: Wendy Peacock, JD 210-916-1442 wendy.s.peacock@amedd.army.mil

Locations
United States, Texas
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Wendy Peacock, JD    210-916-1442    wendy.s.peacock@amedd.army.mil   
Principal Investigator: Michael Schlicher, PhD         
Sponsors and Collaborators
Samueli Institute for Information Biology
Investigators
Principal Investigator: Michael Schlicher, PhD Brooke Army Medical Center
  More Information

No publications provided

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT01752010     History of Changes
Other Study ID Numbers: C.2009.098
Study First Received: December 14, 2012
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014