Clinical trial NCT03267810: TENS Trial to Prevent Neuropathic Pain in SCI
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Neuropathic Pain
Transcutaneous Electrical Nerve Stimulation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2017-08-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;
* 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

Primary outcomes:
measure: The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
timeFrame: 12 months
measure: Neuropathic Pain Symptom Inventory (NPSI) Scores
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 months
measure: Pain Interference With Function
timeFrame: 12 months
measure: Depressive Symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Elizabeth Felix, PhD
role: PRINCIPAL_INVESTIGATOR
References: