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

Brooke Army Medical Center1 site in 1 country75 target enrollmentJanuary 2013

ConditionsChronic Low Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Low Back Pain
Sponsor: Brooke Army Medical Center
Enrollment: 75
Locations: 1
Primary Endpoint: Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

August 31, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brooke Army Medical Center

Responsible Party

Principal Investigator

Ann Marie Nayback-Beebe, PhD, RN

COL

Brooke Army Medical Center

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

Outcomes

Primary Outcomes

Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)

Time Frame: Week 0, week 5, week 9

Secondary Outcomes

Change over time on the Oswestry Disability Questionnaire (ODQ)(Week 0, week 5, week 9)
Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)(Week 0, week 5, week 9)
Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)(Week 0, week 5, week 9)
2 questions on treatment perception(week 5)
Change over time on the Patient Health Questionnaire -9 (PHQ-9)(Week 0, week 5, week 9)
Change over time on the Pittsburgh Sleep Quality Index (PSQI)(Week 0, week 5, week 9)
Abbreviated acceptability rating profile - modified (AARP)(week 5)
Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5(Week 0, week 5, week 9)
Change over time on the Quality of Life - Health Survey (SF-12)(Week 0, week 5, week 9)
Change over time on oral consumption of analgesic medications(Week 0, week 5, week 9)