Chronic PainNCT02330315

Effects of tDCS and tUS on Pain Perception in OA of the Knee

A study testing transcranial direct current stimulation (tDCS) and transcranial ultrasound (TUS) in people with Chronic Pain and Osteoarthritis, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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?: 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: 28 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Aug 2016
Phase: Interventional
Are there results?: None posted in the registry

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 the knee as self-reported.
Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
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 Hospital
Boston, Massachusetts, 02129

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 Osteoarthritis of the Knee.

Conditions: Chronic Pain, Osteoarthritis
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, Osteoarthritis

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 intensity of 2mA. 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 NCT02330315
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 Pain Scale
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).
Measured: Measured for approximately 2 months

Secondary outcomes (13)

Changes in Mood
The investigators will measure safety of tDCS and TUS by measuring changes in the Visual Analog Mood Scale (VAMS).
Measured: Measured for approximately 2 months
Changes in cognition, attention, and focus
The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition, attention, and focus with the California Computerized Assessment Package (CalCap) mini.
Measured: Measured for approximately 2 months
Adverse Events
At each session, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. The scale will also be administered at the follow-ups.
Measured: Measured for approximately 2 months
Physical Examinations
Trained study staff will perform standard physical examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Measured: Measured for approximately 2 months
Single Leg Standing Balance Test
The investigators will measure how long the subject can stand on one foot in order to measure any changes in balance
Measured: Measured for approximately 2 months
Knee Proprioceptive Test
Proprioceptive acuity will be assessed by the ability to reproduce passive positioning of the leg with eyes closed.
Measured: Measured for approximately 2 months
Knee Extensor/Flexor Force Test
The investigators will measure whether there are changes in knee extension/flexion abilities.
Measured: Measured for approximately 2 months
Knee Range of Motion (ROM)
The knee range of motion (flexion/extension angle) will be recorded with an electrogoniometer and motion analysis capture system.
Measured: Measured for approximately 2 months
Step Test
Subject will be asked to stand unsupported with the feet parallel to each other and a block 5 cm directly in front of them. Subject will then be advised which leg is the stepping leg and asked to place the whole foot onto the block, then return it fully down to the floor. This procedure will be repeated as fast as possible.
Measured: Measured for approximately 2 months
Functional Reach Test
The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.
Measured: Measured for approximately 2 months
Timed Up and Go Test
The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end.
Measured: Measured for approximately 2 months
Changes in quality of life
The investigators will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in quality of life and physical functioning.
Measured: Measured for approximately 2 months
Neurological Examinations
Trained study staff will perform standard neurological examinations at several points throughout the study to ensure subject safety. Baseline findings will be compared to the findings observed at the various time points throughout the study to ensure there are no significant changes that may be study related.
Measured: Measured for approximately 2 months

Timeline

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

Mar 2015Aug 2016

First posted1 Jan 2015 (estimated)
Study startMar 2015
Primary completionJun 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330315
Sponsor's protocol ID: 2014P002496
Status last verified: Apr 2020
First submitted: 12 Dec 2014
Last updated: 24 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. 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: NCT02330315
Acronym / sponsor ID: 2014P002496
Conditions: Chronic Pain, Osteoarthritis
Keywords: transcranial direct current stimulation, transcranial ultrasound, non-invasive brain stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Collaborators: Highland Instruments, Inc.
Study start: Mar 2015
Primary completion: Jun 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 1 Jan 2015 (estimated)
Results: Not posted in the source record

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

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 (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 the knee as self-reported.
Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.

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
transcranial direct current stimulation (tDCS)Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. 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 Pain Scale
Time frame: Measured for approximately 2 months
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain in subjects with osteoarthritis knee pain. The investigators will also look at changes in the Von Frey assessment and pain pressure threshold (PPT).

13 secondary outcomes

Changes in Mood
Time frame: Measured for approximately 2 months
Changes in cognition, attention, and focus
Time frame: Measured for approximately 2 months
Adverse Events
Time frame: Measured for approximately 2 months
Physical Examinations
Time frame: Measured for approximately 2 months
Single Leg Standing Balance Test
Time frame: Measured for approximately 2 months
Knee Proprioceptive Test
Time frame: Measured for approximately 2 months
Knee Extensor/Flexor Force Test
Time frame: Measured for approximately 2 months
Knee Range of Motion (ROM)
Time frame: Measured for approximately 2 months
Step Test
Time frame: Measured for approximately 2 months
Functional Reach Test
Time frame: Measured for approximately 2 months
Timed Up and Go Test
Time frame: Measured for approximately 2 months
Changes in quality of life
Time frame: Measured for approximately 2 months
Neurological Examinations
Time frame: Measured for approximately 2 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.

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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.

Timothy Wagner, PhD principal investigator

Highland Instruments, Inc.

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 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: finished, as of the sponsor's last update on 24 Apr 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Measured for approximately 2 months). 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 NCT02330315.

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 24 Apr 2020.