Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Chronic Low Back Pain (NCT NCT02768129)

Last Updated: 2019-08-20

Results Overview

Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

8 weeks total

Results posted on

2019-08-20

Participant Flow

Of the 30 participants that were consented, 9 participants were ineligible, withdrew, or were lost to contact before commencing tDCS.

Participant milestones

Participant milestones
Measure	Sham tDCS 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: sham	Active tDCS 10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: active stimulation: 2 milliamp (mA), 20 mins
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

Transcranial Direct Current Stimulation for Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS n=10 Participants 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: active : 2 mA, 20 mins	Sham tDCS n=11 Participants 10 sessions sham transcranial direct current stimulation (tDCS) sham transcranial direct current stimulation: sham	Total n=21 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 8.8 • n=93 Participants	60.7 years STANDARD_DEVIATION 11.8 • n=4 Participants	63.1 years STANDARD_DEVIATION 10.5 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized White	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Years of Education	14.0 years STANDARD_DEVIATION 2.6 • n=93 Participants	14.7 years STANDARD_DEVIATION 2.6 • n=4 Participants	14.4 years STANDARD_DEVIATION 2.7 • n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks total

Outcome measures

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: active stimulation: 2 milliamp (mA), 20 mins
West Haven-Yale Multidimensional Pain Inventory (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 weeks total

The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety.

Outcome measures

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: active stimulation: 2 milliamp (mA), 20 mins
Pain Anxiety Symptom Scale 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

Butler Hospital

Phone: (401) 455-6200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place