MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain

NCT02701075 | Unknown

• 1 other identifier: TSNRP-N13-04
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy; Low Back Pain

Keywords

peripheral neuropathy; traumatic tissue injury; radiculopathy

Outcome Measures

Primary Outcomes (1)

• Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)

  Baseline, Week 3, Week 6

Secondary Outcomes (1)

• Change over time in oral consumption of analgesic medications

  Baseline, Week 3, Week 6

Other Outcomes (7)

• 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 anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, Week 3, Week 6

• Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M)

  Baseline, Week 3, Week 6

Study Arms (2)

MC5-A Scrambler Therapy

EXPERIMENTAL

MC5-A Scrambler Therapy is an electroanalgesia device that interferes with pain signal transmission by using nerve fibers as a passive means to convey a no pain message to the central nervous system. Electrodes are placed on dermatomes that correspond to the area of pain. Patient is treated for 30 minutes and given up to 10 treatment sessions.

Device: MC5-A Scrambler Therapy

MC5-A Scrambler Therapy Sham Device

SHAM COMPARATOR

The MC5-A Scrambler Therapy Device will be used as an active sham device in this randomized double blind study. Participants assigned to this arm will not receive active therapy.

Device: MC5-A Scrambler Therapy Sham Device

Interventions

MC5-A Scrambler Therapy DEVICE

up to 10 sessions, each session lasting 30 minutes

Also known as: Calmare

MC5-A Scrambler Therapy

MC5-A Scrambler Therapy Sham Device DEVICE

up to 10 sessions, each session lasting 30 minutes

Also known as: Calmare Sham

MC5-A Scrambler Therapy Sham Device

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Marie Nayback-Beebe, PhD, FNP-BC

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LTC Ann Marie Nayback-Beebe

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: March 8, 2016
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: August 31, 2017
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)