TENS Trial to Prevent Neuropathic Pain in SCI

Not Applicable

Terminated

• Conditions: Spinal Cord Injuries
• Interventions: Other: Sham TENS; Device: TENS

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-14
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Results First Submitted: 2023-05-31
• Results First Submitted QC: 2023-05-31
• Results First Posted: 2023-06-22
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Age ≥ 18;
• Traumatic spinal cord injury;
• Date of injury occurring within four months of study enrollment.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TENS	Sham TENS	Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
Active TENS	TENS	Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.

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.
Number of Participants With Adverse Events	12 months	Number of participants reporting adverse events related to study treatment as evaluated by physician
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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States