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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Miami
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Elizabeth Felix
Research Professor
University of Miami
Eligibility Criteria
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;
- •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
Outcomes
Primary Outcomes
The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
Time Frame: 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
Time Frame: 12 months
NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
Secondary Outcomes
- Pain Interference With Function(12 months)
- Number of Participants With Adverse Events(12 months)
- Depressive Symptoms(12 months)