Chronic PainNCT02723929
Effects of tDCS and tUS on Pain Perception in OA of the Knee
A study testing active low-intensity transcranial electrical stimulation/active transcranial ultrasound in people with Chronic Pain and Osteoarthritis, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain, Osteoarthritis
- What is being tested?
- active low-intensity transcranial electrical stimulation/active transcranial ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 7 Dec 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 18-85 years old.
- Diagnosis of chronic osteoarthritis with pain of either knee as self-reported.
- Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.
- Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.
- Pain resistant 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.
- Having the ability to feel pain as self-reported.
Who cannot join
- Pregnancy or trying to become pregnant in the next 6 months.
- History of alcohol or drug abuse within the past 6 months as self-reported
- Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
- Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
- Epilepsy.
- Use of carbamazepine within the past 6 months as self-reported.
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- Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
- History of unexplained fainting spells as self-reported.
- Head injury resulting in more than a momentary loss of consciousness
- History of neurosurgery as self-reported.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts, 02129
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 Osteoarthritis of the Knee
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
- Conditions
- Chronic Pain, Osteoarthritis
- Being tested
- active low-intensity transcranial electrical stimulation/active transcranial ultrasound, Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound
- Keywords
- transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation
- Medical subject headings
- Chronic Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active low-intensity transcranial electrical stimulation/active transcranial ultrasoundDevice
Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes.
Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasoundDevice
Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active Electrical Stim/Active Ultrasound | Experimental | Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. Receives: Device: active low-intensity transcranial electrical stimulation/active transcranial ultrasound |
| Sham Electrical Stim/Sham Ultrasound | Sham comparator | Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. Receives: Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Scale as Measured by VAS
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee.
The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Average Daily Dose of Acetaminophen Equivalent
Analgesic use (average daily dose of acetaminophen equivalent)
Measured: 8 weeks
Changes in Pain Scale as Measured by VAS
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee.
The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain. Since we are using a difference, smaller values (negative) represent a better outcome.
Measured: Baseline and 4 weeks post-stimulation
Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
This measures the endogenous pain modulatory pathway. This study will evaluate DNIC in pain patients using pressure as the test stimulus, and cold water as the conditioning stimulus. DNIC will be induced approximately 1-min later by having subjects immerse their hand into a water bath maintained at 10-12˚C for approximately 1 min. Parallel to the last 30s of DNIC conditioning (cold water immersion), the pressure test stimulus will be reapplied. DNIC response will be calculated as the difference between the average of pain ratings from the test stimulus minus the average of pain ratings during the conditioned stimulus. Larger percentage change means a better outcome.
Measured: Baseline and 8 weeks
Percentage Change From Baseline in the Single Leg Standing Balance Test
We will record the time (seconds) for which a subject is able to stand unsupported on one foot while looking straight ahead with hands on hips. Larger percentage change means a better outcome.
Measured: Baseline and 8 weeks
Percentage Change From Baseline in the Step Test
The subject was asked to stand unsupported with their feet parallel to each other in front of a step. We assessed the number of times the participant could place their foot up onto the step and return it to the floor over a 15-sec interval. Larger percentage change means a better outcome.
Measured: Baseline and 8 weeks
Percentage Change in Functional Reach Test From Baseline
Subject will be instructed to stand next to, but not touch the wall, and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. Smoothness of wrist movement is assessed as the subject was asked to outstretch their arm in a maximal forward reach, while maintaining a fixed base of support. Smoothness is dimensionless and is calculated as mean speed divided by peak speed. Larger percentage change means a better outcome.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startSep 2016
- Primary completion15 Aug 2019
- Study completion7 Dec 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.
- 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
- tDCS and tUS
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Highland Instruments, Inc.
- Responsible party
- Principal investigator, Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723929
- Sponsor's protocol ID
- 2016P000486
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2016
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02723929
- Acronym / sponsor ID
- 2016P000486
- Conditions
- Chronic Pain, Osteoarthritis
- Keywords
- transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Highland Instruments, Inc.
- Study start
- Sep 2016 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 17 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- tDCS and tUS
| Arm | Type | Receives |
|---|---|---|
| Active Electrical Stim/Active Ultrasound | Experimental | Device: active low-intensity transcranial electrical stimulation/active transcranial ultrasoundSubjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes. |
| Sham Electrical Stim/Sham Ultrasound | Sham comparator | Device: Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasoundSubjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide informed consent to participate in the study.
- Subjects between 18-85 years old.
- Diagnosis of chronic osteoarthritis with pain of either knee as self-reported.
- Existing knee pain of at least 3 on a 0-10 VAS scale on average over the past 6 months.
- Pain of at least 3 on a 0-10 VAS scale on average over the week prior to the first stimulation session.
Key exclusion criteria (10 listed)
- Pregnancy or trying to become pregnant in the next 6 months.
- History of alcohol or drug abuse within the past 6 months as self-reported
- Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
- Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
- Epilepsy.
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 |
|---|---|---|
| active low-intensity transcranial electrical stimulation/active transcranial ultrasoundSubjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes. | Device | Active Electrical Stim/Active Ultrasound |
| Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasoundSubjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes. Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes. | Device | Sham Electrical Stim/Sham Ultrasound |
Primary outcome
Changes in Pain Scale as Measured by VAS
Time frame: Baseline and 8 weeks
Changes in the Visual Analogue Scale (VAS) for pain were measured in order to determine whether transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Osteoarthritis of the Knee. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain and is reported following the full course of therapy. Since we are using a difference, smaller values (negative) represent a better outcome
6 secondary outcomes
Average Daily Dose of Acetaminophen Equivalent
Time frame: 8 weeks
Changes in Pain Scale as Measured by VAS
Time frame: Baseline and 4 weeks post-stimulation
Percentage Change in Diffuse Noxious Inhibitory Controls (DNIC) From Baseline
Time frame: Baseline and 8 weeks
Percentage Change From Baseline in the Single Leg Standing Balance Test
Time frame: Baseline and 8 weeks
Percentage Change From Baseline in the Step Test
Time frame: Baseline and 8 weeks
Percentage Change in Functional Reach Test From Baseline
Time frame: Baseline and 8 weeks
Results and safety
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.
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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?
A study testing active low-intensity transcranial electrical stimulation/active transcranial ultrasound in people with Chronic Pain and Osteoarthritis, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 7 inclusion and 10 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 Aug 2021). 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 Pain Scale as Measured by VAS (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.