Trial Outcomes & Findings for TENS Trial to Prevent Neuropathic Pain in SCI (NCT NCT03267810)
NCT ID: NCT03267810
Last Updated: 2023-07-14
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
12 months
Results posted on
2023-07-14
Participant Flow
Participant milestones
| Measure |
Active TENS
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads, two applied paraspinally at the level of spinal cord injury, and two applied on the ventral side of the body 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.
Sham TENS: Inactive electrodes - for two 15 minute trials, neither high nor low frequency.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TENS Trial to Prevent Neuropathic Pain in SCI
Baseline characteristics by cohort
| Measure |
Active TENS
n=13 Participants
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
|
Sham TENS
n=13 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.38 years
STANDARD_DEVIATION 13.27 • n=99 Participants
|
38.15 years
STANDARD_DEVIATION 17.13 • n=107 Participants
|
35.77 years
STANDARD_DEVIATION 15.21 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process.
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
Outcome measures
| Measure |
Sham TENS
n=13 Participants
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.
|
Active TENS
n=13 Participants
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
|
|---|---|---|
|
The Percentage of Subjects Who Develop Chronic Neuropathic Pain.
|
46 percentage of participants
|
31 percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process.
NPSI has a total score ranging from 0 to 100 with the higher score indicating more severe symptoms of neuropathic pain
Outcome measures
| Measure |
Sham TENS
n=13 Participants
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.
|
Active TENS
n=13 Participants
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
|
|---|---|---|
|
Neuropathic Pain Symptom Inventory (NPSI) Scores
|
14 score on a scale
Interval 0.0 to 23.0
|
23 score on a scale
Interval 0.0 to 33.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process.
Number of participants reporting adverse events related to study treatment as evaluated by physician
Outcome measures
| Measure |
Sham TENS
n=13 Participants
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.
|
Active TENS
n=13 Participants
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
|
|---|---|---|
|
Number of Participants With Adverse Events
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process.
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.
Outcome measures
| Measure |
Sham TENS
n=13 Participants
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.
|
Active TENS
n=13 Participants
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
|
|---|---|---|
|
Pain Interference With Function
|
1 score on a scale
Interval 0.0 to 10.0
|
0 score on a scale
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analyses were performed were on all participants enrolled in each arm using the "last observation carried forward" process.
Patient Health Questionnaire - 9 (PHQ-9) has a total score ranging from 0 to 27, with a higher score indicating greater depressive symptoms
Outcome measures
| Measure |
Sham TENS
n=13 Participants
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.
|
Active TENS
n=13 Participants
Participants are given 30 minutes of TENS therapy twice a week for 8 weeks.
TENS: TENS 7000 - : TENS will apply low-level electrical current via four pads affixed to the lower back area. 15 minutes of high frequency followed by 15 minutes of low frequency will be applied at each session
|
|---|---|---|
|
Depressive Symptoms
|
1 score on a scale
Interval 1.0 to 5.0
|
4 score on a scale
Interval 3.0 to 8.0
|
Adverse Events
Active TENS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham TENS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TENS
n=13 participants at risk
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
|
Sham TENS
n=13 participants at risk
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.
|
|---|---|---|
|
General disorders
episode of severe nerve pain
|
0.00%
0/13 • 12 months
|
7.7%
1/13 • 12 months
|
|
Injury, poisoning and procedural complications
broken foot
|
7.7%
1/13 • 12 months
|
0.00%
0/13 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • 12 months
|
7.7%
1/13 • 12 months
|
|
General disorders
increased pain
|
7.7%
1/13 • 12 months
|
7.7%
1/13 • 12 months
|
|
General disorders
prolonged dysesthesia
|
15.4%
2/13 • 12 months
|
7.7%
1/13 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place