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

Not Applicable

Completed

• Conditions: Chronic Pain; Sleep; PTSD Symptoms; Depression

• Registration Number: NCT01752010
• Lead Sponsor: Samueli Institute for Information Biology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-18
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chronic pain	Baseline; post-intervention; one-month follow up.

Secondary Outcome Measures

Name	Time	Method
Depression, PTSD symptoms, Sleep.	Baseline; post-intervention; one-month follow up.

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States