We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TENS Trial to Prevent Neuropathic Pain in SCI (TENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03267810
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : October 10, 2022
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Elizabeth Roy 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 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
Actual Primary Completion Date : March 4, 2022
Actual Study Completion Date : March 4, 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 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session

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 - for two 15 minute trials, neither high nor low frequency.




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. 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

  2. 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 Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 months ]
    Number of participants reporting adverse events related to study treatment as evaluated by physician

  2. Pain interference with function [ Time Frame: 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.

  3. Depressive symptoms [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Felix, PhD University of Miami
Layout table for additonal information
Responsible Party: Elizabeth Roy Felix, Research 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: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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 Roy Felix, University of Miami:
Neuropathic Pain
Transcutaneous Electrical Nerve Stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
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