Spinal Cord Injuries
Conditions
Keywords
Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation
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.
Interventions
DEVICETENS
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
OTHERSham TENS
Inactive electrodes - for two 15 minute trials, neither high nor low frequency.
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Who Develop Chronic Neuropathic Pain. | 12 months | 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 | 12 months | NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 12 months | Number of participants reporting adverse events related to study treatment as evaluated by physician |
| Pain Interference With Function | 12 months | 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 | 12 months | Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active TENS Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
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 | 13 |
| Sham TENS Electrodes are placed on participants for 30 minutes twice a week for 8 weeks without TENS stimulation.
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Sham TENS | Total | Active TENS |
|---|---|---|---|
| Age, Continuous | 38.15 years STANDARD_DEVIATION 17.13 | 35.77 years STANDARD_DEVIATION 15.21 | 33.38 years STANDARD_DEVIATION 13.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 13 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 4 / 13 | 4 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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
Time frame: 12 months
Population: Analyses were performed were on all participants enrolled in each arm using the last observation carried forward process.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active TENS | Neuropathic Pain Symptom Inventory (NPSI) Scores | 23 score on a scale |
| Sham TENS | Neuropathic Pain Symptom Inventory (NPSI) Scores | 14 score on a scale |
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
Time frame: 12 months
Population: Analyses were performed were on all participants enrolled in each arm using the last observation carried forward process.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active TENS | The Percentage of Subjects Who Develop Chronic Neuropathic Pain. | 31 percentage of participants |
| Sham TENS | The Percentage of Subjects Who Develop Chronic Neuropathic Pain. | 46 percentage of participants |
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
Time frame: 12 months
Population: Analyses were performed were on all participants enrolled in each arm using the last observation carried forward process.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active TENS | Depressive Symptoms | 4 score on a scale |
| Sham TENS | Depressive Symptoms | 1 score on a scale |
Secondary
Number of Participants With Adverse Events
Number of participants reporting adverse events related to study treatment as evaluated by physician
Time frame: 12 months
Population: Analyses were performed were on all participants enrolled in each arm using the last observation carried forward process.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active TENS | Number of Participants With Adverse Events | 1 Participants |
| Sham TENS | Number of Participants With Adverse Events | 2 Participants |
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.
Time frame: 12 months
Population: Analyses were performed were on all participants enrolled in each arm using the last observation carried forward process.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active TENS | Pain Interference With Function | 0 score on a scale |
| Sham TENS | Pain Interference With Function | 1 score on a scale |