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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC5-A Scrambler Therapy | Experimental | 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. |
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| MC5-A Scrambler Therapy Sham Device | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC5-A Scrambler Therapy | Device | up to 10 sessions, each session lasting 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change over time in pain on the Numerical Rating Scale-11 Pain Score (NRS-11) | Baseline, Week 3, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change over time in oral consumption of analgesic medications | Baseline, Week 3, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change over time in depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) at week 3 | Baseline, Week 3, Week 6 | |
| Change over time in anxiety symptoms on the Generalized Anxiety Disorder-7 (GAD-7) | Baseline, Week 3, Week 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Marie Nayback-Beebe, PhD, FNP-BC | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2018 | |
| Reset | Apr 19, 2018 | |
| Release | Jan 30, 2026 | |
| Reset | Feb 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2018 | Apr 19, 2018 | |||
| Jan 30, 2026 |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
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| MC5-A Scrambler Therapy Sham Device | Device | up to 10 sessions, each session lasting 30 minutes |
|
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| Change over time in posttraumatic stress symptoms on the Posttraumatic Stress Disorder Checklist - Military (PCL-M) | Baseline, Week 3, Week 6 |
| Change over time in quality of sleep symptoms on the Pittsburgh Quality of Sleep Index (PQSI) | Baseline, Week 3, Week 6 |
| Change over time in perception of health on the Quality Of Life - Health Survey (SF-12) | Baseline, Week 3, Week 6 |
| Change over time in the perception of social support on the Interpersonal Relationships Inventory Short Form (IPRI-SF) | Baseline, Week 3, Week 6 |
| Abbreviated Acceptability Rating Profile | Week 6 |
| Feb 18, 2026 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |