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

Brooke Army Medical Center

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Usual Care (Medication + Exercise); Device: Biomodulator

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02707094

TSNRP-N12-006

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: All

Ages: 18 to 62 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 2 patient groups

Usual Care (Medication + Exercise)

Other group

Description:

Usual Care: Participants will receive guidance on over-the-counter and prescribed pain medications to use to treat their chronic low back pain symptoms. The Research Coordinator (RC) will provide instructions for low back pain stretching and strengthening exercises. The Licensed Provider (LP) will determine if any exercises should be excluded based on their physical limitations. Participants enrolled in the usual care treatment arm will track the frequency of their back stretching and strengthening exercise sessions on the Pain Medication \& Exercise Diary. For the purpose of this study, treatment compliance will be met if participants complete the exercises a minimum of three times per week.

Treatment:

Other: Usual Care (Medication + Exercise)

Biomodulator + Usual Care

Experimental group

Description:

Biomodulator + Usual Care treatment group: Usual care, as described above, will be provided to all participants randomly allocated to this treatment group, in addition to treatment with the Biomodulator three times per week x 4 weeks. The licensed provider will review medication and treatment logs, prescribe pain medications as indicated, and assess for treatment side effects. In addition to treatment with the Biomodulator, the participant will perform back stretching and core strengthening exercises for a minimum of three times per week as instructed and will be told to use their prescribed pain medications as needed to self-treat their low back pain symptoms (as previously described above).

Treatment:

Device: Biomodulator

Other: Usual Care (Medication + Exercise)