Trial Outcomes & Findings for Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain (NCT NCT02954432)

Last Updated: 2025-09-29

Results Overview

Changes in Mechanical Temporal Summation (TS) from hand will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in reducing pain of subjects with non-specific chronic low back pain.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 3.5 months

Results posted on

2025-09-29

Participant Flow

40 subjects were enrolled and randomized

Participant milestones

Participant milestones
Measure	Active tDCS + Active TUS Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.	Sham tDCS + Sham TUS Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA0. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Overall Study STARTED	20	20
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

one subject did not declare sex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS + Active TUS - Phase II n=20 Participants Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.	Sham tDCS + Sham TUS - Phase II n=20 Participants Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.	Total n=40 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION 18.6 • n=20 Participants	47.3 years STANDARD_DEVIATION 15.7 • n=20 Participants	48.2 years STANDARD_DEVIATION 17.1 • n=40 Participants
Sex: Female, Male Female	6 Participants n=20 Participants • one subject did not declare sex	14 Participants n=19 Participants • one subject did not declare sex	20 Participants n=39 Participants • one subject did not declare sex
Sex: Female, Male Male	14 Participants n=20 Participants • one subject did not declare sex	5 Participants n=19 Participants • one subject did not declare sex	19 Participants n=39 Participants • one subject did not declare sex
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=20 Participants	1 Participants n=20 Participants	6 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=20 Participants	17 Participants n=20 Participants	31 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	2 Participants n=20 Participants	5 Participants n=20 Participants	7 Participants n=40 Participants
Race (NIH/OMB) White	13 Participants n=20 Participants	13 Participants n=20 Participants	26 Participants n=40 Participants
Race (NIH/OMB) More than one race	2 Participants n=20 Participants	0 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline and 3.5 months

Outcome measures

Outcome measures
Measure	Active tDCS + Active TUS n=20 Participants Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.	Sham tDCS + Sham TUS n=20 Participants Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Changes in Mechanical Temporal Summation (Hand)	15 TSPS percentage change Standard Error 8	-4 TSPS percentage change Standard Error 9

PRIMARY outcome

Timeframe: Baseline and 3.5 months

Changes in Conditional Pain Modulation (CPM) will be measured in the hand in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) is effective in increasing the pain pressure threshold in subjects with non-specific chronic low back pain.

Outcome measures

Outcome measures
Measure	Active tDCS + Active TUS n=20 Participants Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.	Sham tDCS + Sham TUS n=20 Participants Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Changes in Conditional Pain Modulation (Hand)	94 CPM percentage changes Standard Error 22	-4 CPM percentage changes Standard Error 19

PRIMARY outcome

Timeframe: Baseline and 3.5 months

Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to measure any changes in pain levels when subjects come in for sessions.

Outcome measures

Outcome measures
Measure	Active tDCS + Active TUS n=20 Participants Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.	Sham tDCS + Sham TUS n=20 Participants Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Changes in Pain	45 percentage changes Standard Error 2.4	24 percentage changes Standard Error 2

Adverse Events

Active tDCS + Active TUS

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Sham tDCS + Sham TUS

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active tDCS + Active TUS n=20 participants at risk Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of active tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of active TUS. During active stimulation the ultrasound will be active for the full 20 minutes.	Sham tDCS + Sham TUS n=20 participants at risk Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). transcranial Direct Current Stimulation (tDCS): Subjects will receive 20 minutes of sham tDCS at intensity of 2 milliamps (mA). The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Transcranial Ultrasound (TUS): Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.
Nervous system disorders tingling	75.0% 15/20 • Number of events 102 • 3.5 months Adverse effects were collected with a questionnaire for adverse effects	65.0% 13/20 • Number of events 74 • 3.5 months Adverse effects were collected with a questionnaire for adverse effects

Additional Information

Felipe Fregni

Spaulding Rehabilitation Hospital

Phone: 6179526158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60