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TENS Trial to Prevent Neuropathic Pain in SCI (TENS)

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ClinicalTrials.gov Identifier: NCT03267810
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : June 7, 2021
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Elizabeth Felix, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: TENS Other: Sham TENS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active TENS
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
Device: TENS
TENS 7000

Sham Comparator: Sham TENS
Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
Other: Sham TENS
Inactive electrodes




Primary Outcome Measures :
  1. 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

  2. The severity of chronic neuropathic pain [ Time Frame: 12 months ]
    as measured by a self-report rating of neuropathic pain symptoms using Neuropathic Pain Symptom Inventory scores


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]
    Will collect number of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267810


Contacts
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Contact: Sequoia Jackson, MPH 305-243-3575 snj31@med.miami.edu
Contact: Eleuterio D Baliwis, BSN 305-243-3543 ebaliwis@med.miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sequoia N Jackson, MPH    305-243-3575    snj31@med.miami.edu   
Contact: Eleuterio D Baliwis, BSN    305-243-3543    ebaliwis@med.miami.edu   
Principal Investigator: Elizabeth R Felix, PhD         
Sponsors and Collaborators
University of Miami
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Elizabeth Felix, PhD University of Miami
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Responsible Party: Elizabeth Felix, Research Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03267810    
Other Study ID Numbers: 20160951
90SI5023 ( Other Grant/Funding Number: Nat. Institute on Disability, Indep. Living, and Rehab. Res. )
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elizabeth Felix, University of Miami:
Neuropathic Pain
Transcutaneous Electrical Nerve Stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations