Clinical trial NCT02701075: MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
Official title: MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Low Back Pain
Keywords: peripheral neuropathy
traumatic tissue injury
radiculopathy
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2016-03-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
timeFrame: Baseline, Week 3, Week 6
Secondary outcomes:
measure: Change over time in oral consumption of analgesic medications
timeFrame: Baseline, Week 3, Week 6
Other outcomes:
measure: Change over time in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at week 3
timeFrame: Baseline, Week 3, Week 6
measure: Change over time in anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, Week 3, Week 6
measure: Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M)
timeFrame: Baseline, Week 3, Week 6
measure: Change over time in quality of sleep symptoms on the Pittsburgh Quality of Sleep Index (PQSI)
timeFrame: Baseline, Week 3, Week 6
measure: Change over time in perception of health on the Quality Of Life - Health Survey (SF-12)
timeFrame: Baseline, Week 3, Week 6
measure: Change over time in the perception of social support on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
timeFrame: Baseline, Week 3, Week 6
measure: Abbreviated Acceptability Rating Profile
timeFrame: Week 6
Locations:
city: Ft Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Ann Marie Nayback-Beebe, PhD, FNP-BC
role: PRINCIPAL_INVESTIGATOR
References: