TENS Trial to Prevent Neuropathic Pain in SCI

Spinal Cord Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03267810
• Other study ID #: 20160951
• Secondary ID: 90SI5023
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: March 4, 2022

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Spinal Cord Injuries

Intervention

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

Other:
• Sham TENS
Inactive electrodes - for two 15 minute trials, neither high nor low frequency.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Adverse Events	Number of participants reporting adverse events related to study treatment as evaluated by physician	12 months
Secondary	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
Secondary	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