NCT02701075

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	MC5-A Scrambler Therapy	up to 10 sessions, each session lasting 30 minutes
DEVICE	MC5-A Scrambler Therapy Sham Device	up to 10 sessions, each session lasting 30 minutes

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-12-01
• Completion: 2017-08-31
• First posted: 2016-03-08
• Last updated: 2017-02-07

Locations

1 site across 1 country: United States