A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
CompletedNot applicableNCT02707094
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
- Conditions
- Interventions
- Device: Biomodulator
- Other: Usual Care (Medication + Exercise)
- Sponsor
- Brooke Army Medical Center
- Start date
- 2013-01
- Primary completion
- 2015-11
- Sex
- All
- Age range
- from 18 Years to 62 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02707094