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

February 6, 2017 updated by: Ann Marie Nayback-Beebe, PhD, RN, Brooke Army Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Ft Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MC5-A Scrambler Therapy
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
up to 10 sessions, each session lasting 30 minutes
Other Names:
  • Calmare
Sham Comparator: MC5-A Scrambler Therapy Sham Device
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
up to 10 sessions, each session lasting 30 minutes
Other Names:
  • Calmare Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change over time in oral consumption of analgesic medications
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6

Other Outcome Measures

Outcome Measure
Time Frame
Change over time in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at week 3
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6
Change over time in anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6
Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M)
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6
Change over time in quality of sleep symptoms on the Pittsburgh Quality of Sleep Index (PQSI)
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6
Change over time in perception of health on the Quality Of Life - Health Survey (SF-12)
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6
Change over time in the perception of social support on the Interpersonal Relationships Inventory Short Form (IPRI-SF)
Time Frame: Baseline, Week 3, Week 6
Baseline, Week 3, Week 6
Abbreviated Acceptability Rating Profile
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Ann Marie Nayback-Beebe, PhD, FNP-BC, Brooke Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

August 31, 2017

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSNRP-N13-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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