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

Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752010
• Other study ID #: C.2009.098
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: May 18, 2015
• Start date: May 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Samueli Institute for Information Biology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• PTSD Symptoms
• Sleep

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Samueli Institute for Information Biology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain		Baseline; post-intervention; one-month follow up.	No
Secondary	Depression, PTSD symptoms, Sleep.		Baseline; post-intervention; one-month follow up.	No