Trial Outcomes & Findings for tDCS for Chronic Low Back Pain (NCT NCT02771990)
NCT ID: NCT02771990
Last Updated: 2023-03-29
Results Overview
The WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity \[better\]).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-03-29
Participant Flow
Of the 30 participants that were consented, 9 participants were ineligible, withdrew, or were lost to contact before commencing tDCS.
Participant milestones
| Measure |
Sham tDCS
10 sessions sham transcranial direct current stimulation (tDCS)
Sham transcranial direct current stimulation: sham stimulation
|
Active tDCS
10 sessions active transcranial direct current stimulation (tDCS)
transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
tDCS for Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Sham tDCS
n=11 Participants
10 sessions sham transcranial direct current stimulation (tDCS)
Sham transcranial direct current stimulation: sham stimulation
|
Active tDCS
n=10 Participants
10 sessions active transcranial direct current stimulation (tDCS)
transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Years of Education
|
14.7 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
14.0 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
14.4 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksThe WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity \[better\]).
Outcome measures
| Measure |
Sham tDCS
n=11 Participants
10 sessions sham transcranial direct current stimulation (tDCS)
Sham transcranial direct current stimulation: sham
|
Active tDCS
n=10 Participants
10 sessions active transcranial direct current stimulation (tDCS)
transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
|
|---|---|---|
|
West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating
|
35.3 score on a scale
Standard Deviation 17.7
|
48.4 score on a scale
Standard Deviation 21.2
|
PRIMARY outcome
Timeframe: 8 weeksThe PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety).
Outcome measures
| Measure |
Sham tDCS
n=11 Participants
10 sessions sham transcranial direct current stimulation (tDCS)
Sham transcranial direct current stimulation: sham
|
Active tDCS
n=10 Participants
10 sessions active transcranial direct current stimulation (tDCS)
transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
|
|---|---|---|
|
Pain Anxiety Symptom Scale (PASS-20) Rating
|
26.4 score on a scale
Standard Deviation 22.0
|
26.3 score on a scale
Standard Deviation 23.6
|
Adverse Events
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Greenberg
Providence Veterans Affairs Medical Center
Phone: 4012737100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place