Status:
TERMINATED
TENS Trial to Prevent Neuropathic Pain in SCI
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to: 1) test whether transcutaneous electrical nerve stimulation (TENS) after spinal cord injury can reduce the onset of post-injury neuropathic pain; and 2) to le...
Eligibility Criteria
Inclusion
- Age ≥ 18;
- Traumatic spinal cord injury;
- Date of injury occurring within four months of study enrollment.
Exclusion
- More than four months since date of injury;
- Contraindications for the study intervention, transcutaneous electrical nerve stimulation (TENS),88 including:
- Implanted electronic device such as a pacemaker;
- Cardiovascular problems;
- Pregnancy;
- Epilepsy;
- Cancer;
- Persons with a spinal cord injury at the C2 level, as placement of TENS electrodes on the neck is not recommended;
- Cognitive dysfunction which limits the ability of the participant to adequately understand procedures and risks.
- Prisoners
- Pregnant Women
- Special populations:
- Adults unable to consent: excluded from study
- Individuals -who are not yet adults: individuals who are less than 18 years old will be excluded from the study
- Pregnant women: Women who are known to be pregnant will not be recruited into the study. A pregnancy test will be administered to females prior to enrollment in TENS (or sham) treatment. Women who become pregnant before or during the 8-week TENS treatment period will be discontinued from the study. Women who become pregnant after the 8-week TENS treatment portion of the study will continue to be enrolled, and followed according to protocol guidelines (no information will be collected specifically on the pregnancy or fetus).
- Prisoners: excluded from study
- Neonates: not applicable
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03267810
Start Date
August 14 2017
End Date
March 4 2022
Last Update
July 14 2023
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136