TENS Trial to Prevent Neuropathic Pain in SCI (TENS)
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|ClinicalTrials.gov Identifier: NCT03267810|
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : October 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: TENS Other: Sham TENS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-blinded, Controlled Trial of Early-intervention TENS for the Reduction of the Prevalence and Severity of Chronic Neuropathic Pain During the First Year After Spinal Cord Injury|
|Actual Study Start Date :||August 14, 2017|
|Actual Primary Completion Date :||March 4, 2022|
|Actual Study Completion Date :||March 4, 2022|
Experimental: Active TENS
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
Sham Comparator: Sham TENS
Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
Other: Sham TENS
Inactive electrodes - for two 15 minute trials, neither high nor low frequency.
- The percentage of subjects who develop chronic neuropathic pain. [ Time Frame: 12 months ]as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of >=2 screening positive for Neuropathic Pain in people with spinal cord injury
- Neuropathic Pain Symptom Inventory (NPSI) Scores [ Time Frame: 12 months ]NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
- Number of participants with adverse events [ Time Frame: 12 months ]Number of participants reporting adverse events related to study treatment as evaluated by physician
- Pain interference with function [ Time Frame: 12 months ]Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.
- Depressive symptoms [ Time Frame: 12 months ]Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267810
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Elizabeth Felix, PhD||University of Miami|