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

NCT ID: NCT02701075

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

MC5-A Scrambler Therapy

Intervention Type: DEVICE

up to 10 sessions, each session lasting 30 minutes

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.

Group Type: SHAM_COMPARATOR

MC5-A Scrambler Therapy Sham Device

Intervention Type: DEVICE

up to 10 sessions, each session lasting 30 minutes

Interventions

MC5-A Scrambler Therapy

up to 10 sessions, each session lasting 30 minutes

Intervention Type: DEVICE

MC5-A Scrambler Therapy Sham Device

up to 10 sessions, each session lasting 30 minutes

Intervention Type: DEVICE

Other Intervention Names

Calmare; Calmare Sham

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Ann Marie Nayback-Beebe, PhD, RN

LTC Ann Marie Nayback-Beebe

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Marie Nayback-Beebe, PhD, FNP-BC

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

TSNRP-N13-04

Identifier Type: -

Identifier Source: org_study_id