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TENS Trial to Prevent Neuropathic Pain in SCI (TENS)

Primary Purpose

Spinal Cord Injuries

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TENS
Sham TENS
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active TENS

Sham TENS

Arm Description

Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.

Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2017
Last Updated
July 1, 2023
Sponsor
University of Miami
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT03267810
Brief Title
TENS Trial to Prevent Neuropathic Pain in SCI
Acronym
TENS
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with recruitment
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TENS
Arm Type
Experimental
Arm Description
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
Arm Title
Sham TENS
Arm Type
Sham Comparator
Arm Description
Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham TENS
Intervention Description
Inactive electrodes - for two 15 minute trials, neither high nor low frequency.
Primary Outcome Measure Information:
Title
The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
Description
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
Time Frame
12 months
Title
Neuropathic Pain Symptom Inventory (NPSI) Scores
Description
NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Number of participants reporting adverse events related to study treatment as evaluated by physician
Time Frame
12 months
Title
Pain Interference With Function
Description
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.
Time Frame
12 months
Title
Depressive Symptoms
Description
Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Felix, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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TENS Trial to Prevent Neuropathic Pain in SCI

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