Knee Pain ChronicNCT06132412
Transcranial Direct Current Stimulation in Conjunction With Individualized Physical Therapy for Individuals With Chronic Knee Pain
A study testing transcranial direct current stimulation and physical therapy in people with Knee Pain Chronic, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
Background: There is a high prevalence of chronic pain in the US, with nearly half of adults experiencing chronic pain. Chronic pain is associated with impaired mobility, specifically ambulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- transcranial direct current stimulation and physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years old
- Knee pain
- Knee pain duration >/= 3 months
Who cannot join
- General exclusion criteria
- History of surgery on affected knee
- Pregnant
- tDCS exclusion criteria
- Skin hypersensitivity
- History of contact dermatitis
- Any other skin or scalp condition that could be aggravated by tDCS
- Previous adverse reactions to tDCS
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Hospital
Chicago, Illinois, 60612
About this study
Background: There is a high prevalence of chronic pain in the US, with nearly half of adults experiencing chronic pain. Chronic pain is associated with impaired mobility, specifically ambulation. Treatment for chronic knee pain is complex given that pain is not only due to peripheral sources, but also due to alterations of the central nervous system (CNS). Majority of physical therapy (PT) interventions involve a bottom-up approach targeting the peripheral pain sources and many patients (~66%) do not respond to this treatment approach. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) is a novel and promising option for a top-down intervention that can have neuromodulatory effects on the CNS and may better target central factors associated with chronic pain. Purpose: To determine if tDCS delivered to the primary motor cortex in conjunction with individualized PT will result in greater improvements in pain and function compared to sham tDCS with individualized PT in individuals with chronic knee pain. Methods: This study will be performed at outpatient PT clinics at the University of Illinois Hospital. Eligible participants will include patients with chronic knee pain (duration > 3 months) who have not undergone surgery to this area and are scheduled to receive formal PT intervention. Subjects will be randomized to the active tDCS + PT group or sham tDCS + PT group and will receive the intervention for 8 sessions. Outcomes include pain ratings, pressure pain thresholds, patient specific functional scale, lower extremity functional scale, quadriceps strength, knee range of motion, 2-minute walk test, 5 time sit to stand, patient health questionnaire-2, and Central Sensitization Inventory. Impact: The use of adjuvant therapies such as tDCS have the potential to optimize rehabilitation treatment for individuals with chronic pain by offering a more comprehensive treatment that targets peripheral and central sources of pain.
- Conditions
- Knee Pain Chronic
- Being tested
- transcranial direct current stimulation, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tDCS
Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that can have neuromodulatory effects on central nervous system structures, specifically the primary motor cortex (M1), and can potentially target maladaptive plasticity and nociplastic sources of pain. There is both anodal and cathodal tDCS, anodal stimulation increases excitability of the cortex whereas cathodal stimulation decreases excitability. At the synaptic level, anodal tDCS induces effects that mimic long term potentiation (LTP), while cathodal tDCS results in long term depression.
physical therapyOther
Also called PT
Participants will receive individualized and impairment-based physical therapy treatment for their knee pain. This treatment can involve manual therapy, exercise or balance training depending on their particular needs.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS+PT | Experimental | For those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The intensity will be set at 2mA for the active tDCS group, following a 30 second ramp-up time. The participants in the active tDCS group will undergo 20 minutes of tDCS treatment prior to receiving individualized PT intervention. Receives: Device: transcranial direct current stimulation; Other: physical therapy |
| sham tDCS+PT | Sham comparator | For those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT tDCS device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The participants in the sham tDCS group will undergo 20 minutes of sham tDCS treatment prior to receiving individualized PT intervention. Receives: Device: transcranial direct current stimulation; Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment ratio
We will record the number of patients screened and enrolled in the study.
Measured: through study completion, an average of 1 year
Pain (NPRS)
This will be measured subjectively using the Numeric Pain rating scale (NPRS). The PT or key research personnel with ask the participant their pain rating using a 0-10 scale. They will ask the current pain intensity rating, highest and lowest pain intensity rating in the past 2 week period.
Measured: baseline, every follow-up session through study completion
Two-minute walk test (2MWT)
Distance walked, number of rest breaks and the assistive device(s) used during a 2MWT will be measured. From this test walking speed can also be calculated.
Measured: baseline, at final intervention session
Secondary outcomes (9)
Pressure pain threshold (PPT)
PPT will be obtained with an electronic pressure algometer and the pressure will be recorded in kPa to allow for comparison to norms
Measured: baseline, at final intervention session
central sensitization inventory (CSI)
CSI is a self-report questionnaire that will be used as a secondary outcome to identify patients that may have symptoms related to central sensitization or nociplastic pain which may allow for subgroup analysis of data to occur
Measured: baseline, at final intervention session
Lower extremity functional scale (LEFS)
self-report questionnaire where participants will rate the difficulty level they have with various daily mobility tasks
Measured: baseline, at final intervention session
Patient specific functional scale (PSFS)
The PSFS is a self-report outcome measure that is individualized to the patient's specific activity impairments. The participant will choose 3 activities that are limited or difficult for them due to their knee pain and then will rate the level of difficulty of each task. On this scale, 0 means that the participant is unable to complete the activity at all and 10 means that the participant is able to perform the activity at the same level as before the injury or problem.
Measured: baseline, at final intervention session
Five time sit to stand (5STS)
5STS will time the amount of time it takes for the participant to stand up and sit down five times as fast as they can from a standard chair without the use of their upper extremities if possible. If participants require upper extremity support to complete the task then this will be documented
Measured: baseline, at final intervention session
knee range of motion (ROM)
): Knee flexion and extension ROM will be measured with the patient in a supine position if possible. If participants have knee ROM measured in a position other than supine this will be documented.
Measured: baseline, at final intervention session
quadriceps strength
Quadriceps strength will be assessed using a hand-held dynamometer with the patient in a seated position
Measured: baseline, at final intervention session
Treatment adherence
Adherence to tDCS and physical therapy treatment will also be recorded.
Measured: through study completion, an average of 1 year
tDCS satisfaction
Participants and clinicians involved in the study will also complete a survey following completion of the study regarding their impressions (positive and negative) regarding tDCS.
Measured: at final intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start6 Jun 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Pain ChronicStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangeetha Madhavan, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132412
- Sponsor's protocol ID
- 2023-1323
- Status last verified
- May 2026
- First submitted
- 30 Oct 2023
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balinski M, Frey-Law L, Madhavan S. Effects of Transcranial Direct Current Stimulation and Individualized Physical Therapy on Pain and Function in Individuals With Chronic Knee Pain: A Pilot Study. Physiother Res Int. 2026 Oct;31(4):e70333. doi: 10.1002/pri.70333.
PubMed 42689852
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in Conjunction With Individualized Physical Therapy for Individuals With Chronic Knee Pain
- ClinicalTrials.gov ID
- NCT06132412
- Acronym / sponsor ID
- 2023-1323
- Conditions
- Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Nov 2023 (actual)
- 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.
Background: There is a high prevalence of chronic pain in the US, with nearly half of adults experiencing chronic pain. Chronic pain is associated with impaired mobility, specifically ambulation. Treatment for chronic knee pain is complex given that pain is not only due to peripheral sources, but also due to alterations of the central nervous system (CNS). Majority of physical therapy (PT) interventions involve a bottom-up approach targeting the peripheral pain sources and many patients (~66%) do not respond to this treatment approach. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) is a novel and promising option for a top-down intervention that can have neuromodulatory effects on the CNS and may better target central factors associated with chronic pain. Purpose: To determine if tDCS delivered to the primary motor cortex in conjunction with individualized PT will result in greater improvements in pain and function compared to sham tDCS with individualized PT in individuals with chronic knee pain. Methods: This study will be performed at outpatient PT clinics at the University of Illinois Hospital. Eligible participants will include patients with chronic knee pain (duration > 3 months) who have not undergone surgery to this area and are scheduled to receive formal PT intervention. Subjects will be randomized to the active tDCS + PT group or sham tDCS + PT group and will receive the intervention for 8 sessions. Outcomes include pain ratings, pressure pain thresholds, patient specific functional scale, lower extremity functional scale, quadriceps strength, knee range of motion, 2-minute walk test, 5 time sit to stand, patient health questionnaire-2, and Central Sensitization Inventory. Impact: The use of adjuvant therapies such as tDCS have the potential to optimize rehabilitation treatment for individuals with chronic pain by offering a more comprehensive treatment that targets peripheral and central sources of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS+PT | Experimental | Device: transcranial direct current stimulation, Other: physical therapyFor those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The intensity will be set at 2mA for the active tDCS group, following a 30 second ramp-up time. The participants in the active tDCS group will undergo 20 minutes of tDCS treatment prior to receiving individualized PT intervention. |
| sham tDCS+PT | Sham comparator | Device: transcranial direct current stimulation, Other: physical therapyFor those participants assigned to the active or sham tDCS groups, the overall set-up will be identical between groups and will use the Mini-CT tDCS device. However, the sham tDCS group will have the tDCS device turned off after 30 seconds of stimulation. Saline-soaked sponge electrodes that are 35 cm^2 in size will be used for both the active and sham tDCS groups. For electrode placement, the active electrode (anode) will be placed over M1 contralateral to the side of primary knee pain (over C3/4 using the 10-20 system for electrode placement), while the reference electrode (cathode) will be over the contralateral supraorbital region, which is ipsilateral to the painful knee (Fp2 using the 10-20 system). The participants in the sham tDCS group will undergo 20 minutes of sham tDCS treatment prior to receiving individualized PT intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 18 years old
- Knee pain
- Knee pain duration >/= 3 months
Key exclusion criteria (8 listed)
- General exclusion criteria
- History of surgery on affected knee
- Pregnant
- tDCS exclusion criteria
- Skin hypersensitivity
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 stimulationAlso: tDCSTranscranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that can have neuromodulatory effects on central nervous system structures, specifically the primary motor cortex (M1), and can potentially target maladaptive plasticity and nociplastic sources of pain. There is both anodal and cathodal tDCS, anodal stimulation increases excitability of the cortex whereas cathodal stimulation decreases excitability. At the synaptic level, anodal tDCS induces effects that mimic long term potentiation (LTP), while cathodal tDCS results in long term depression. | Device | active tDCS+PT, sham tDCS+PT |
| physical therapyAlso: PTParticipants will receive individualized and impairment-based physical therapy treatment for their knee pain. This treatment can involve manual therapy, exercise or balance training depending on their particular needs. | Other | active tDCS+PT, sham tDCS+PT |
Primary outcome
Recruitment ratio
Time frame: through study completion, an average of 1 year
We will record the number of patients screened and enrolled in the study.
Pain (NPRS)
Time frame: baseline, every follow-up session through study completion
This will be measured subjectively using the Numeric Pain rating scale (NPRS). The PT or key research personnel with ask the participant their pain rating using a 0-10 scale. They will ask the current pain intensity rating, highest and lowest pain intensity rating in the past 2 week period.
Two-minute walk test (2MWT)
Time frame: baseline, at final intervention session
Distance walked, number of rest breaks and the assistive device(s) used during a 2MWT will be measured. From this test walking speed can also be calculated.
9 secondary outcomes
Pressure pain threshold (PPT)
Time frame: baseline, at final intervention session
central sensitization inventory (CSI)
Time frame: baseline, at final intervention session
Lower extremity functional scale (LEFS)
Time frame: baseline, at final intervention session
Patient specific functional scale (PSFS)
Time frame: baseline, at final intervention session
Five time sit to stand (5STS)
Time frame: baseline, at final intervention session
knee range of motion (ROM)
Time frame: baseline, at final intervention session
quadriceps strength
Time frame: baseline, at final intervention session
Treatment adherence
Time frame: through study completion, an average of 1 year
tDCS satisfaction
Time frame: at final intervention session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 42689852Balinski M, Frey-Law L, Madhavan S. Effects of Transcranial Direct Current Stimulation and Individualized Physical Therapy on Pain and Function in Individuals With Chronic Knee Pain: A Pilot Study. Physiother Res Int. 2026 Oct;31(4):e70333. doi: 10.1002/pri.70333.
- Individual participant dataSharing planned: No
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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 transcranial direct current stimulation and physical therapy in people with Knee Pain Chronic, run by University of Illinois at Chicago 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 3 inclusion and 8 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 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment ratio (time frame: through study completion, an average of 1 year). 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 NCT06132412, 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 11 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.