TENS Trial to Prevent Neuropathic Pain in SCI

University of Miami

Status

Terminated

Conditions

Spinal Cord Injuries

Treatments

Other: Sham TENS

Device: TENS

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT03267810

90SI5023 (Other Grant/Funding Number)

20160951

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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