Peripheral Neuropathy, Low Back Pain
Conditions
Keywords
peripheral neuropathy, traumatic tissue injury, radiculopathy
Brief summary
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.
Interventions
DEVICEMC5-A Scrambler Therapy
up to 10 sessions, each session lasting 30 minutes
DEVICEMC5-A Scrambler Therapy Sham Device
up to 10 sessions, each session lasting 30 minutes
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11) | Baseline, Week 3, Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change over time in oral consumption of analgesic medications | Baseline, Week 3, Week 6 |
Other
| Measure | Time frame |
|---|---|
| Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) | Baseline, Week 3, Week 6 |
| Change over time in quality of sleep symptoms on the Pittsburgh Quality of Sleep Index (PQSI) | Baseline, Week 3, Week 6 |
| Change over time in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at week 3 | Baseline, Week 3, Week 6 |
| Change over time in the perception of social support on the Interpersonal Relationships Inventory Short Form (IPRI-SF) | Baseline, Week 3, Week 6 |
| Abbreviated Acceptability Rating Profile | Week 6 |
| Change over time in perception of health on the Quality Of Life - Health Survey (SF-12) | Baseline, Week 3, Week 6 |
| Change over time in anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7) | Baseline, Week 3, Week 6 |
Countries
United States
Outcome results
None listed