Comparing Acupuncture, BioModulator, and Transcutaneous Electrical Nerve Stimulation for Symptomatic Treatment of Chronic Pain.
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.
1 other identifier
interventional
98
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started May 2010
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 14, 2012
CompletedFirst Posted
Study publicly available on registry
December 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 19, 2015
May 1, 2015
3.9 years
December 14, 2012
May 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Chronic pain
Baseline; post-intervention; one-month follow up.
Secondary Outcomes (1)
Depression, PTSD symptoms, Sleep.
Baseline; post-intervention; one-month follow up.
Study Arms (3)
Acupuncture Treatment
ACTIVE COMPARATORTraditional Chinese acupuncture.
Tennant™ Biomodulator Treatment
ACTIVE COMPARATORTranscutaneous electrical nerve stimulation (TENS) Treatment
ACTIVE COMPARATORInterventions
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.
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Related Publications (1)
Peacock KS, Stoerkel E, Libretto S, Zhang W, Inman A, Schlicher M, Cowsar JD Jr, Eddie D, Walter J. A randomized trial comparing the Tennant Biomodulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture for the treatment of chronic pain in military service members. Mil Med Res. 2019 Dec 2;6(1):37. doi: 10.1186/s40779-019-0227-4.
PMID: 31791416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Schlicher, PhD
Brooke Army Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2012
First Posted
December 18, 2012
Study Start
May 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 19, 2015
Record last verified: 2015-05