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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02701075
• Other study ID #: TSNRP-N13-04
• Status: Active, not recruiting
• Phase: N/A
• First received: January 22, 2014
• Last updated: February 6, 2017
• Start date: September 2013
• Est. completion date: August 31, 2017

Study information

• Verified date: February 2017
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: August 31, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• MC5-A Scrambler Therapy
up to 10 sessions, each session lasting 30 minutes
• MC5-A Scrambler Therapy Sham Device
up to 10 sessions, each session lasting 30 minutes

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Ft Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change over time in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at week 3		Baseline, Week 3, Week 6
Other	Change over time in anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7)		Baseline, Week 3, Week 6
Other	Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M)		Baseline, Week 3, Week 6
Other	Change over time in quality of sleep symptoms on the Pittsburgh Quality of Sleep Index (PQSI)		Baseline, Week 3, Week 6
Other	Change over time in perception of health on the Quality Of Life - Health Survey (SF-12)		Baseline, Week 3, Week 6
Other	Change over time in the perception of social support on the Interpersonal Relationships Inventory Short Form (IPRI-SF)		Baseline, Week 3, Week 6
Other	Abbreviated Acceptability Rating Profile		Week 6
Primary	Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11)		Baseline, Week 3, Week 6
Secondary	Change over time in oral consumption of analgesic medications		Baseline, Week 3, Week 6