Clinical trial NCT02707094: A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
Official title: A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: back
pain
chronic
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2016-03-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
timeFrame: Week 0, week 5, week 9
Secondary outcomes:
measure: Change over time on the Patient Health Questionnaire -9 (PHQ-9)
timeFrame: Week 0, week 5, week 9
measure: Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Week 0, week 5, week 9
measure: Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5
timeFrame: Week 0, week 5, week 9
measure: Change over time on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 0, week 5, week 9
measure: Change over time on the Oswestry Disability Questionnaire (ODQ)
timeFrame: Week 0, week 5, week 9
measure: Change over time on the Quality of Life - Health Survey (SF-12)
timeFrame: Week 0, week 5, week 9
measure: Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
timeFrame: Week 0, week 5, week 9
measure: 2 questions on treatment perception
timeFrame: week 5
measure: Abbreviated acceptability rating profile - modified (AARP)
timeFrame: week 5
measure: Change over time on oral consumption of analgesic medications
timeFrame: Week 0, week 5, week 9
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Ann Marie Nayback-Beebe, PhD, FNP-BC
role: PRINCIPAL_INVESTIGATOR
References: