TENS Trial to Prevent Neuropathic Pain in SCI
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT03267810
- Lead Sponsor
- University of Miami
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
- Age ≥ 18;
- Traumatic spinal cord injury;
- Date of injury occurring within four months of study enrollment.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Percentage of Subjects Who Develop Chronic Neuropathic Pain. 12 months as defined by a score of ≥2 on the Spinal Cord Injury Pain Inventory (SCIPI), a self-report scale of symptoms. SCIPI has a total score ranging from 0 to 4 with scores of \>=2 screening positive for Neuropathic Pain in people with spinal cord injury
Neuropathic Pain Symptom Inventory (NPSI) Scores 12 months NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
- Secondary Outcome Measures
Name Time Method Pain Interference With Function 12 months Self-report composite rating scale of interference of pain with activities, mood, and sleep. This scale has a total score ranging from 0 to 30, with a higher score indicating greater pain interference.
Depressive Symptoms 12 months Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms
Number of Participants With Adverse Events 12 months Number of participants reporting adverse events related to study treatment as evaluated by physician
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States
University of Miami🇺🇸Miami, Florida, United States