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

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

August 31, 2016

Conditions
Chronic Low Back Pain
Interventions
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.

Trial Locations (1)

78234

Brooke Army Medical Center, Fort Sam Houston

All Listed Sponsors
lead

Brooke Army Medical Center

FED

NCT02707094 - A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain | Biotech Hunter | Biotech Hunter