TENS Trial to Prevent Neuropathic Pain in SCI

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: TENS
* Other: Sham TENS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TENS<br>Participants are given 30 minutes of TENS therapy twice a week for 8 weeks. | Device: TENS<br>* TENS: TENS 7000 - : TENS applies low-level electrical current via four pads, 2 pads affixed paraspinally, at the level of the spinal cord injury, and 2 affixed on the ventral side to areas within the dermatome corresponding to the level of injury. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session<br>|
| Sham Comparator: Sham TENS<br>Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation. | Other: Sham TENS<br>* Inactive electrodes - for two 15 minute trials, neither high nor low frequency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Develop Chronic Neuropathic Pain. | 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 | 12 months | 
| Neuropathic Pain Symptom Inventory (NPSI) Scores | NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Number of participants reporting adverse events related to study treatment as evaluated by physician | 12 months | 
| Pain Interference With Function | 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. | 12 months | 
| Depressive Symptoms | Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation