TENS Trial to Prevent Neuropathic Pain in SCI

Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Age Range:18 - Any
Start Date:August 14, 2017
End Date:October 1, 2021
Contact:Kate T McManus, BS

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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

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 learn more about this kind of pain and who is at risk for suffering from this
type of pain after spinal cord injury. Neuropathic pain is a type of pain that occurs in
about 50% of people with spinal cord injury. This type of pain is usually described as
"burning" or "tingling," and is present around the level of injury and/or in areas below the
level of injury. The investigators' goal is to try a non-drug treatment (TENS) that may help
prevent this pain from occurring. Pain symptoms will be compared between the study
participants who receive active TENS and the study participants who receive a sham TENS

Inclusion Criteria:

- Age ≥ 18;

- Traumatic spinal cord injury;

- Date of injury occurring within four months of study enrollment.

Exclusion Criteria:

- 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
We found this trial at
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Elizabeth R Felix, PhD
Phone: 305-243-3575
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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