TENS Trial to Prevent Neuropathic Pain in SCI
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | August 14, 2017 |
| End Date: | October 1, 2021 |
| Contact: | Kate T McManus, BS |
| Email: | k.mcmanus1@umiami.edu |
| Phone: | 305-243-3575 |
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
treatment.
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
treatment.
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
1
site
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...
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