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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707094
• Other study ID #: TSNRP-N12-006
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 31, 2018
• Start date: January 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: January 2018
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 31, 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Biomodulator
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:
• Usual Care (Medication + Exercise)
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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change over time on the Numerical Rating Scale-11 Pain Score (NRS-11)		Week 0, week 5, week 9
Secondary	Change over time on the Patient Health Questionnaire -9 (PHQ-9)		Week 0, week 5, week 9
Secondary	Change over time on the Generalized Anxiety Disorder - 7 (GAD-7)		Week 0, week 5, week 9
Secondary	Change over time on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) at week 5		Week 0, week 5, week 9
Secondary	Change over time on the Pittsburgh Sleep Quality Index (PSQI)		Week 0, week 5, week 9
Secondary	Change over time on the Oswestry Disability Questionnaire (ODQ)		Week 0, week 5, week 9
Secondary	Change over time on the Quality of Life - Health Survey (SF-12)		Week 0, week 5, week 9
Secondary	Change over time on the Interpersonal Relationships Inventory Short Form (IPRI-SF)		Week 0, week 5, week 9
Secondary	2 questions on treatment perception	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.	week 5
Secondary	Abbreviated acceptability rating profile - modified (AARP)	Acceptability	week 5
Secondary	Change over time on oral consumption of analgesic medications		Week 0, week 5, week 9