Back to resultsMC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
Primary Purpose
Peripheral Neuropathy, Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MC5-A Scrambler Therapy
MC5-A Scrambler Therapy Sham Device
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring peripheral neuropathy, traumatic tissue injury, radiculopathy
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
Sites / Locations
- Brooke Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MC5-A Scrambler Therapy
MC5-A Scrambler Therapy Sham Device
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
Secondary Outcome Measures
Change over time in oral consumption of analgesic medications
Full Information
NCT ID
NCT02701075
First Posted
January 22, 2014
Last Updated
February 6, 2017
Sponsor
Brooke Army Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02701075
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Low Back Pain
Keywords
peripheral neuropathy, traumatic tissue injury, radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MC5-A Scrambler Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
MC5-A Scrambler Therapy Sham Device
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MC5-A Scrambler Therapy
Other Intervention Name(s)
Calmare
Intervention Description
up to 10 sessions, each session lasting 30 minutes
Intervention Type
Device
Intervention Name(s)
MC5-A Scrambler Therapy Sham Device
Other Intervention Name(s)
Calmare Sham
Intervention Description
up to 10 sessions, each session lasting 30 minutes
Primary Outcome Measure Information:
Title
Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)
Time Frame
Baseline, Week 3, Week 6
Secondary Outcome Measure Information:
Title
Change over time in oral consumption of analgesic medications
Time Frame
Baseline, Week 3, Week 6
Other Pre-specified Outcome Measures:
Title
Change over time in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at week 3
Time Frame
Baseline, Week 3, Week 6
Title
Change over time in anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame
Baseline, Week 3, Week 6
Title
Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M)
Time Frame
Baseline, Week 3, Week 6
Title
Change over time in quality of sleep symptoms on the Pittsburgh Quality of Sleep Index (PQSI)
Time Frame
Baseline, Week 3, Week 6
Title
Change over time in perception of health on the Quality Of Life - Health Survey (SF-12)
Time Frame
Baseline, Week 3, Week 6
Title
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
Title
Abbreviated Acceptability Rating Profile
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Marie Nayback-Beebe, PhD, FNP-BC
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Ft Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MC5-A Scrambler Therapy for the Treatment of Chronic Neuropathic Extremity Pain
We'll reach out to this number within 24 hrs