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Completed

NCT Number: NCT02707094

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

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).

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Key information

Conditions

Chronic Low Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomodulator

Device

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.

Other names: Tennant Biomodulator, Transcutaneous electrical nerve stimulator for pain relief

Usual Care (Medication + Exercise)

Other

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.

Primary outcomes

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

    Time frame: Week 0, week 5, week 9

Secondary outcomes

  1. Change over time on the Patient Health Questionnaire -9 (PHQ-9)

    Time frame: Week 0, week 5, week 9

  2. Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)

    Time frame: Week 0, week 5, week 9

  3. Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5

    Time frame: Week 0, week 5, week 9

  4. Change over time on the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Week 0, week 5, week 9

  5. Change over time on the Oswestry Disability Questionnaire (ODQ)

    Time frame: Week 0, week 5, week 9

  6. Change over time on the Quality of Life - Health Survey (SF-12)

    Time frame: Week 0, week 5, week 9

  7. Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)

    Time frame: Week 0, week 5, week 9

  8. 2 questions on treatment perception

    Time frame: week 5

    • Did you feel this treatment intervention was a success or failure (select one)? Complete Success Partial Success Partial Failure Complete Failure Explain why.
    • 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.

  9. Abbreviated acceptability rating profile - modified (AARP)

    Time frame: week 5

    Acceptability

  10. Change over time on oral consumption of analgesic medications

    Time frame: Week 0, week 5, week 9

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 14, 2016
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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