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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
The Biomodulator is a type of very low frequency TENS known as pulsed electromagnetic field therapy (PEMF). Unlike TENS devices that deliver 1-80 milliamperes of electrical current, PEMF devices deliver short bursts of electrical microamperes (millionths of an ampere) to injured tissues without producing heat or interfering with nerve or muscle function. Micro-current levels between 20-500 microampere appear to be most effective at relieving pain and inflammation and promoting tissue healing by realigning the natural electrical balance that exists within the cells that has become disrupted due to injury.
The study LP will prescribe an analgesic medication regimen based on the participant's needs. These medications may consist of Non-steroidal anti-inflammatory Drugs (NSAIDs) (ibuprofen, naproxen sodium, etc.), muscle relaxants (Flexeril, Robaxin, valium, etc.), non-narcotic analgesic medications (acetaminophen, aspirin, tramadol, etc.), or narcotic medications (Tylenol #3, Percocet, Vicodin, etc.) depending on the severity of their pain and co-morbid conditions. The RC will also provide instructions for LBP stretching and strengthening exercises. The following exercises will be recommended as a daily regimen: the partial curl, cat and camel, pelvic tilt, quadriceps, arm/leg raises,trunk rotation, single knee to chest stretch, standing hamstring stretch, and double knee to chest stretch.
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)
Time frame: Week 0, week 5, week 9
Change over time on the Patient Health Questionnaire -9 (PHQ-9)
Time frame: Week 0, week 5, week 9
Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Week 0, week 5, week 9
Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5
Time frame: Week 0, week 5, week 9
Change over time on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0, week 5, week 9
Change over time on the Oswestry Disability Questionnaire (ODQ)
Time frame: Week 0, week 5, week 9
Change over time on the Quality of Life - Health Survey (SF-12)
Time frame: Week 0, week 5, week 9
Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
Time frame: Week 0, week 5, week 9
2 questions on treatment perception
1. Did you feel this treatment intervention was a success or failure (select one)? Complete Success Partial Success Partial Failure Complete Failure Explain why. 2. Did you find it easy or difficult to adhere to the treatment plan (select one)? Very Easy Somewhat Easy Somewhat Difficult Very Difficult Explain why.
Time frame: week 5
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Abbreviated acceptability rating profile - modified (AARP)
Acceptability
Time frame: week 5
Change over time on oral consumption of analgesic medications
Time frame: Week 0, week 5, week 9