MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Back Pain, Neurology |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 2/8/2017 |
| Start Date: | September 2013 |
| End Date: | August 31, 2017 |
The FDA-approved MC5-A Scrambler Therapy (MC5-A ST) is an electroanalgesia device that
interferes with pain signal transmission by using nerve fibers as a passive means to convey
a message of normality (sans pain) to the central nervous system. While preliminary research
has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and
failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain
secondary to traumatic musculoskeletal injuries like those experienced in combat has not
been investigated. The purpose of this prospective, double-blind, randomized controlled,
study is to determine if the MC5-A ST is efficacious in altering the biological,
psychological, and social components of the chronic neuropathic pain experience in military
Service Members (SMs) with traumatic musculoskeletal extremity injuries.
interferes with pain signal transmission by using nerve fibers as a passive means to convey
a message of normality (sans pain) to the central nervous system. While preliminary research
has demonstrated its efficacy in treating chronic neuropathic pain secondary to cancer and
failed back surgery syndrome, its effectiveness in treating chronic neuropathic pain
secondary to traumatic musculoskeletal injuries like those experienced in combat has not
been investigated. The purpose of this prospective, double-blind, randomized controlled,
study is to determine if the MC5-A ST is efficacious in altering the biological,
psychological, and social components of the chronic neuropathic pain experience in military
Service Members (SMs) with traumatic musculoskeletal extremity injuries.
Inclusion Criteria:
- military service members (active duty & retirees) between the ages of 18 and 79,
inclusive
- neuropathic pain symptoms present for 3 months or greater prior to entry into the
study
- rated pain intensity equal to or greater than 3 on NRS-11 pain scale
- painful peripheral neuropathy in an extremity that is the result of a traumatic
injury (post-traumatic/ post-surgical neuropathy, stump pain, entrapment neuropathy),
or low back pain with radiculopathy
- stable pain medication treatment regimen
- able to speak and read English, understand the study procedures, and consent to study
participation
Exclusion Criteria:
- pacemaker or other implantable devices
- vena cava, aneurysm clips, coronary or other vascular stents
- pregnancy via a pregnancy test
- history of epilepsy, brain injury, symptomatic brain metastases
- prior celiac plexus block, or other neurolytic pain control treatment, within 4 weeks
- wounds or skin irritation in areas where the electrodes are required to be placed
- cardiac ischemia within the previous 6 months
- severe arrhythmia
- documented history of moderate or severe traumatic brain injury
- latex allergies
- open wound over site of chronic pain
- unable to stop anti-epileptic medications or gabapentin over 2 weeks of MC5-A ST
treatment
- history of electroanalgesia treatment (electroacupuncture, biomodulator, TENS) over
last 30 days
- 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.
- metal implants such as cardiac pacemakers, automatic defibrillators, aneurysm clips,
vena cava clips and skull plates
We found this trial at
1
site
Ft Sam Houston, Texas 78234
Principal Investigator: Chris Weidlich, PhD, RN
Phone: 210-916-0647
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