Chronic PainNCT02954432

Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain

A study testing transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) in people with Chronic Pain and Chronic Low Back Pain, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Chronic Pain, Chronic Low Back Pain
What is being tested?: transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Sep 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to provide informed consent to participate in the study
Subjects between 18 to 85 years old
Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale
Pain resistant (partial or no response) to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
Must have the ability to feel sensation by Von-Frey fiber on the forearm

Who cannot join

Subject is pregnant
Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
History of alcohol or drug abuse within the past 6 months as self reported
Use of carbamazepine within the past 6 months as self reported
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
History of neurological disorders as self reported

Show all 13Show fewer

History of unexplained fainting spells as self reported
History of severe head injury resulting in more than a momentary loss of consciousness as self reported
History of neurosurgery as self reported
Unstable pain
Large placebo responder
Low adherence during the run-in period
Low baseline pain

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Network Research Institute
Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain (NSCLBP).

Conditions: Chronic Pain, Chronic Low Back Pain
Being tested: transcranial Direct Current Stimulation (tDCS), Transcranial Ultrasound (TUS)
Keywords: transcranial Direct Current Stimulation, Transcranial Ultrasound, non-invasive brain stimulation
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcranial Direct Current Stimulation (tDCS)Device
Subjects will receive 20 minutes of either active or sham tDCS at an 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)Device
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.

Study groups in NCT02954432
Study group	Role	What they receive
Active tDCS + Active TUS	Experimental	Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Transcranial Ultrasound (TUS)
Sham tDCS + Sham TUS	Sham comparator	Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Transcranial Ultrasound (TUS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Mechanical Temporal Summation (Hand)
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.
Measured: Baseline and 3.5 months
Changes in Conditional Pain Modulation (Hand)
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.
Measured: Baseline and 3.5 months
Changes in Pain
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.
Measured: Baseline and 3.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Sep 2026

First posted3 Nov 2016 (estimated)
Study startNov 2016
Primary completionNov 2022
Study completionSep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Phase II
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02954432
Sponsor's protocol ID: 2016P001956
Status last verified: Sep 2025
First submitted: 2 Nov 2016
Last updated: 29 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Teixeira PEP, Pacheco-Barrios K, Uygur-Kucukseymen E, Machado RM, Balbuena-Pareja A, Giannoni-Luza S, Luna-Cuadros MA, Cardenas-Rojas A, Gonzalez-Mego P, Mejia-Pando PF, Wagner T, Dipietro L, Fregni F. Electroencephalography Signatures for Conditioned Pain Modulation and Pain Perception in Nonspecific Chronic Low Back Pain-An Exploratory Study. Pain Med. 2022 Mar 2;23(3):558-570. doi: 10.1093/pm/pnab293.
PubMed 34633449

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound (TUS) on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic Low Back Pain (NSCLBP).
ClinicalTrials.gov ID: NCT02954432
Acronym / sponsor ID: 2016P001956
Conditions: Chronic Pain, Chronic Low Back Pain
Keywords: transcranial Direct Current Stimulation, Transcranial Ultrasound, non-invasive brain stimulation
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 40 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Collaborators: Highland Instruments, Inc.
Study start: Nov 2016 (actual)
Primary completion: Nov 2022 (actual)
Study completion: Sep 2026 (estimated)
First posted: 3 Nov 2016 (estimated)
Results: Posted 17 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Phase II

Arm	Type	Receives
Active tDCS + Active TUS	Experimental	Device: transcranial Direct Current Stimulation (tDCS), Device: Transcranial Ultrasound (TUS)Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
Sham tDCS + Sham TUS	Sham comparator	Device: transcranial Direct Current Stimulation (tDCS), Device: Transcranial Ultrasound (TUS)Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Able to provide informed consent to participate in the study
Subjects between 18 to 85 years old
Subjects having non-specific chronic low back pain with existing pain for at least 3 months and having pain on at least half the days in the past 6 months with an average of at least 3 on a 0-10 visual analog scale (VAS) scale
Pain resistant (partial or no response) to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
Must have the ability to feel sensation by Von-Frey fiber on the forearm

Key exclusion criteria (13 listed)

Subject is pregnant
Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
History of alcohol or drug abuse within the past 6 months as self reported
Use of carbamazepine within the past 6 months as self reported
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
transcranial Direct Current Stimulation (tDCS)Subjects will receive 20 minutes of either active or sham tDCS at an 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.	Device	Active tDCS + Active TUS, Sham tDCS + Sham TUS
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.	Device	Active tDCS + Active TUS, Sham tDCS + Sham TUS

Primary outcome

Changes in Mechanical Temporal Summation (Hand)
Time frame: Baseline and 3.5 months
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.
Changes in Conditional Pain Modulation (Hand)
Time frame: 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.
Changes in Pain
Time frame: 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.

Results and safety

Results posted to the registry on 17 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active tDCS + Active TUS	20	12
Sham tDCS + Sham TUS	20	11

Primary outcome: Changes in Mechanical Temporal Summation (Hand)

Time frame: Baseline and 3.5 months. Mean (Standard Error). Unit: TSPS percentage change

Measure	Active tDCS + Active TUS n = 20	Sham tDCS + Sham TUS n = 20
Value	15 (8)	-4 (9)

Primary outcome: Changes in Conditional Pain Modulation (Hand)

Time frame: Baseline and 3.5 months. Mean (Standard Error). Unit: CPM percentage changes

Measure	Active tDCS + Active TUS n = 20	Sham tDCS + Sham TUS n = 20
Value	94 (22)	-4 (19)

Primary outcome: Changes in Pain

Time frame: Baseline and 3.5 months. Mean (Standard Error). Unit: percentage changes

Measure	Active tDCS + Active TUS n = 20	Sham tDCS + Sham TUS n = 20
Value	45 (2.4)	24 (2)

Adverse events

Time frame: 3.5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active tDCS + Active TUS	0 of 20 (0%)	15 of 20 (75%)	0 of 20
Sham tDCS + Sham TUS	0 of 20 (0%)	13 of 20 (65%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34633449Teixeira PEP, Pacheco-Barrios K, Uygur-Kucukseymen E, Machado RM, Balbuena-Pareja A, Giannoni-Luza S, Luna-Cuadros MA, Cardenas-Rojas A, Gonzalez-Mego P, Mejia-Pando PF, Wagner T, Dipietro L, Fregni F. Electroencephalography Signatures for Conditioned Pain Modulation and Pain Perception in Nonspecific Chronic Low Back Pain-An Exploratory Study. Pain Med. 2022 Mar 2;23(3):558-570. doi: 10.1093/pm/pnab293.

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Mechanical Temporal Summation (Hand) (time frame: Baseline and 3.5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02954432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.