TENS Trial to Prevent Neuropathic Pain in SCI

NCT03267810 | Terminated Results DMC FDA Device

• 2 other identifiers: 2016095190SI5023
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Neuropathic Pain; Transcutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Number of Participants With Adverse Events

  12 months

• Pain Interference With Function

  12 months

• Depressive Symptoms

  12 months

Study Arms (2)

Active TENS

EXPERIMENTAL

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

Device: TENS

Sham TENS

SHAM COMPARATOR

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

Other: Sham TENS

Interventions

TENS DEVICE

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

Active TENS

Sham TENS OTHER

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

Sham TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Elizabeth Felix
• Organization: University of Miami

efelix@med.miami.edu

305-243-4497

Study Officials

• Elizabeth Felix, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 30, 2017
• Study Start: August 14, 2017
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: July 14, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)