TENS Trial to Prevent Neuropathic Pain in SCI

NCT ID: NCT03267810

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2022-03-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active TENS

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

Group Type: EXPERIMENTAL

TENS

Intervention Type: 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

Sham TENS

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

Group Type: SHAM_COMPARATOR

Sham TENS

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

Sham TENS

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Felix

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Felix, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

90SI5023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20160951

Identifier Type: -

Identifier Source: org_study_id