TENS Trial to Prevent Neuropathic Pain in SCI

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.

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