TENS Trial to Prevent Neuropathic Pain in SCI (TENS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Sham TENS; Device: TENS

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TENS; Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.	Device: TENS; 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Elizabeth Felix, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): March 4, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Neuropathic Pain; Transcutaneous Electrical Nerve Stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: 20160951; 90SI5023 (Other Grant/Funding Number: Nat. Institute on Disability, Indep. Living, and Rehab. Res.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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