TENS Trial to Prevent Neuropathic Pain in SCI
TerminatedNot applicableNCT03267810
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Device: TENS
- Other: Sham TENS
- Sponsor
- University of Miami
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Start date
- 2017-08-14
- Primary completion
- 2022-03-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03267810