A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain

Completed · Not applicable

Conditions studied: Chronic Low Back Pain

In brief

The purpose of this study is to determine the efficacy of self treatment with the Biomodulator device to decrease chronic low back pain (LBP) in active duty service members. In addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).

Key facts

Study ID

NCT02707094

Run by

Brooke Army Medical Center

People needed

75

Starts

2013-01-01

Expected to finish

2016-08-31

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older, up to 62. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• active duty Service Members (SMs) between the ages of 18 and 62, inclusive
• history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3 months or greater prior to entry into the study
• participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic LBP symptoms on a weekly basis
• must be able to speak and read English and understand the study procedures

You may not qualify if…

• pacemaker or implanted electronic device
• history of stroke, blood clots, or cardiac arrhythmias
• pregnancy
• no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications
• open wound over site of chronic pain;
• history of spinal surgery
• participation in a clinical trial for an investigational drug/ treatment within last 30 days
• undergone treatment with TENS, biofeedback, or acupuncture within last 30 days
• prior treatment with the Biomodulator
• LBP "red flags": fever, trauma, progressive motor or sensory deficit, saddle anesthesia
• participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit

Where it is running

• Brooke Army Medical Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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