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

Samueli Institute for Information Biology

Status: Completed

Conditions: PTSD Symptoms; Chronic Pain; Depression; Sleep

Treatments: Device: Transcutaneous electrical nerve stimulation (TENS) Treatment; Other: Traditional Chinese Acupuncture; Device: Tennant™ Biomodulator Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01752010

C.2009.098

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 3 patient groups

Acupuncture Treatment

Active Comparator group

Description:

Traditional Chinese acupuncture.

Treatment:

Other: Traditional Chinese Acupuncture

Tennant™ Biomodulator Treatment

Active Comparator group

Treatment:

Device: Tennant™ Biomodulator Treatment

Transcutaneous electrical nerve stimulation (TENS) Treatment

Active Comparator group

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS) Treatment