Knee OsteoarthritisNCT07832682
Neurofeedback for Pain Sensitization in Knee Osteoarthritis
A study testing FWR Down-Conditioning Neurofeedback in people with Knee Osteoarthritis, run by Northeastern University.
Trial summary
The goal of this clinical trial is to learn whether a training method called neurofeedback is safe and practical to use in people with knee osteoarthritis (knee OA). Neurofeedback uses a computer screen to show people their body's responses as they happen, so they can learn to change those responses. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- FWR Down-Conditioning Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2031
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 years or older
- Symptomatic knee osteoarthritis meeting the clinical definition in the National Institute for Health and Care Excellence (NICE) guidelines: knee pain for more than 3 months and morning stiffness lasting less than 30 minutes
- Able to speak and understand English
- Able to attend all study visits at the study site in Boston, MA
Who cannot join
- Stimulation safety
- Pacemaker, implanted defibrillator, or other implanted electronic device
- Metal implants in the head
- Implants in the lower limb, including prior knee arthroplasty
- History of seizures or epilepsy
- Prior adverse reaction to transcranial magnetic stimulation
Show all 24Show fewer
- Frequent or severe headaches
- Suspected or diagnosed cardiac disease
- Pregnancy (self-reported)
- Neurological, psychiatric, and medical
- Neurological disease, including multiple sclerosis
- Currently active major depressive disorder, defined as a current clinical diagnosis of major depressive disorder or ongoing treatment for depression; a prior history that is neither active nor treated is not exclusionary
- Insulin-dependent diabetes
- Raynaud's phenomenon, cold urticaria, or other cold-induced reaction
- Large ischaemic scars
- Pain and musculoskeletal
- Lower extremity pain other than knee osteoarthritis
- Skin and sensation at stimulation sites
- Altered skin sensation of the thigh
- Swollen, infected, inflamed, or damaged skin of the thigh
- Substances
- Use of medication known to alter pain perception or cortical excitability, including opioids, gabapentinoids, antidepressants (SSRIs, SNRIs, tricyclics), benzodiazepines, anti-seizure medications, muscle relaxants, prescription sleep medications, and cannabis or cannabinoids
- Use of alcohol or recreational drugs within 12 hours before a study visit
- Radiographic confirmation is not required, consistent with current clinical recommendations for knee osteoarthritis diagnosis. Commonly used medications that do not alter pain perception or cortical excitability are permitted and recorded as covariates.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Targeting Pain Sensitization in Knee Osteoarthritis by Conditioning the Endogenous Pain Control System Using Reflex Conditioning.
The goal of this clinical trial is to learn whether a training method called neurofeedback is safe and practical to use in people with knee osteoarthritis (knee OA). Neurofeedback uses a computer screen to show people their body's responses as they happen, so they can learn to change those responses. The response being trained in this study is a protective reflex in the leg. This reflex is often stronger than normal in people with knee OA, which may be a sign that their nervous system has become more sensitive to pain.
The main questions this study aims to answer are:
Read more
- Is this training safe, and what side effects do people have?
- Can people with knee OA complete the training, and do they find it acceptable?
Researchers will compare people who receive real neurofeedback training with people who receive a placebo (inactive) version of the training. In the placebo version, the electrical pulses are too weak to trigger the reflex, and what appears on the screen is not based on the person's own reflex. Comparing the two groups helps researchers tell which parts of taking part are difficult because of the study set-up itself and which are difficult because of the training.
Participants will:
- Visit a research laboratory at Northeastern University in Boston 7 times: one measurement visit lasting about 3 hours, then 6 training visits lasting about 60 to 90 minutes each. Training visits happen about twice a week, with at least 2 days between visits.
- At the measurement visit, have small sensors placed on the head and legs, receive brief electrical pulses to the leg and brief magnetic pulses to the head, and have their sensitivity to pain checked using brief pressure on the kneecaps and wrist.
- At each training visit, receive brief electrical pulses to the leg while watching a screen. People in the neurofeedback group will try to make a bar on the screen smaller. People in the placebo group will watch a screen that does not reflect their own reflex.
- Answer questionnaires about their knee pain and daily activities.
- Receive a phone call and complete a short online survey about 2 weeks after the last training visit.
A smaller group of participants will take part in the measurement visit only. They may not receive neurofeedback or placebo training.
- Conditions
- Knee Osteoarthritis
- Being tested
- FWR Down-Conditioning Neurofeedback, Sham Feedback
- Keywords
- flexor withdrawal reflex, nociceptive withdrawal reflex, reflex conditioning, operant conditioning, neurofeedback, pain sensitization, central sensitization, movement-evoked pain, quantitative sensory testing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FWR Down-Conditioning NeurofeedbackOther
Participants receive trial-by-trial feedback of flexor withdrawal reflex amplitude.
Sham FeedbackOther
Participants receive sham trial-by-trial feedback of flexor withdrawal reflex amplitude. The placebo condition is matched on instrumentation, session structure, stimulation triggering, and visit burden, and differs in stimulation intensity and in whether displayed feedback derives from the participant's own reflex.
| Study group | Role | What they receive |
|---|---|---|
| FWR Down-Conditioning Neurofeedback | Experimental | Six sessions of operant down-conditioning of the flexor withdrawal reflex with veridical trial-by-trial EMG feedback. Receives: Other: FWR Down-Conditioning Neurofeedback |
| Sham Feedback | Placebo comparator | Six sessions with sub-reflex-threshold stimulation and non-veridical feedback. Receives: Other: Sham Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of participants with at least one adverse event and total event count, characterized by nature, severity, relationship to study procedures, and timing. Serious adverse events reported separately.
Measured: Enrollment through 14 days after the final intervention session (approximately 6 weeks)
Number of participants completing the intervention protocol
Participants completing all 6 intervention sessions, as a proportion of those randomized. Reasons for discontinuation recorded.
Measured: Randomization through final intervention session (approximately 4 weeks)
Percentage of scheduled intervention sessions attended
Sessions attended as a proportion of sessions scheduled, across all randomized participants.
Measured: Intervention period (approximately 3 weeks)
Adherence to the intervention protocol
Proportion of prescribed conditioning stimulations completed per session (225 across 3 blocks of 75), and sessions completed without protocol deviation.
Measured: Intervention period (approximately 3 weeks)
Participant-reported acceptability of the intervention
Survey ratings of usefulness, ease of use, and burden, with identification of most and least helpful components and reasons for non-completion.
Measured: Week 2, Week 3, and Week 5
Screening and enrollment yield
Number screened, number eligible, number enrolled, and number declining, with reasons for ineligibility and declination.
Measured: Duration of recruitment (approximately 30 months)
Secondary outcomes (13)
Change in flexor withdrawal reflex amplitude
Rectified EMG reflex amplitude during conditioning blocks expressed relative to the within-session 25-stimulation baseline, and change across the 6 sessions.
Measured: Week 1 through Week 3
Pain severity
Knee pain rated on a visual analog scale.
Measured: Week 1, Week 3, and Week 5
Pressure pain threshold
Algometry at the patellae and wrist.
Measured: Baseline (Day 1), then Week 1 through Week 3
Temporal summation of pain
Change in pain rating across repeated weighted pinprick stimuli.
Measured: Baseline (Day 1)
Pain-related evoked potential (PREP) amplitude
Peak-to-peak amplitude of pain-related evoked potentials.
Measured: Baseline (Day 1)
Somatosensory-evoked potential (SSEP) amplitude
Peak-to-peak amplitude of somatosensory evoked potentials.
Measured: Baseline (Day 1)
Short-afferent inhibition
Conditioned motor evoked potential amplitude expressed relative to unconditioned response.
Measured: Baseline (Day 1)
Conditioned pain modulation
Change in pressure pain threshold during cold water immersion.
Measured: Baseline (Day 1)
Difference in pain intensity between experimentally evoked and real-world movement-evoked pain
VAS rating following the weight-bearing stimulation protocol minus rating following a participant-selected pain-provoking activity. Unit: mm on a 0-100 visual analog scale.
Measured: Baseline (Day 1)
Difference in WOMAC pain subscale score between experimentally evoked and real-world movement-evoked pain
VAS rating following the weight-bearing stimulation protocol minus rating following a participant-selected pain-provoking activity. Unit: units on a scale, 0-20
Measured: Baseline (Day 1)
Difference in SF-MPQ-2 total score between experimentally evoked and real-world movement-evoked pain
VAS rating following the weight-bearing stimulation protocol minus rating following a participant-selected pain-provoking activity. Unit: units on a scale 0-20.
Measured: Baseline (Day 1)
Change in KOOS Pain subscale score
Knee Injury and Osteoarthritis Outcome Score. Unit: units on a scale, 0-100, higher indicating fewer symptoms.
Measured: Baseline (Day 1), Week 3, and Week 5
Change in ICOAP total score
Intermittent and Constant Osteoarthritis Pain. Unit: units on a scale, 0-100.
Measured: Baseline (Day 1), Week 3, and Week 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- David A Sherman, DPT, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832682
- Sponsor's protocol ID
- 26-05-56
- Other IDs
- 1K23HD118599
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual-level data will be shared in accordance with the NIH Data Management and Sharing Plan approved under award 1K23HD118599. Shared data will include neurophysiological recordings (EMG, EEG-derived evoked potentials, TMS-derived measures), quantitative sensory testing values, and individual-level outcome and demographic data, together with associated data dictionaries and metadata. Direct identifiers will be removed and record identifiers replaced with newly generated codes with no retained crosswalk before any dataset is shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Pain Sensitization in Knee Osteoarthritis by Conditioning the Endogenous Pain Control System Using Reflex Conditioning.
- ClinicalTrials.gov ID
- NCT07832682
- Acronym / sponsor ID
- 26-05-56
- Conditions
- Knee Osteoarthritis
- Keywords
- flexor withdrawal reflex, nociceptive withdrawal reflex, reflex conditioning, operant conditioning, neurofeedback, pain sensitization, central sensitization, movement-evoked pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 22 Sep 2026 (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.
The goal of this clinical trial is to learn whether a training method called neurofeedback is safe and practical to use in people with knee osteoarthritis (knee OA). Neurofeedback uses a computer screen to show people their body's responses as they happen, so they can learn to change those responses. The response being trained in this study is a protective reflex in the leg. This reflex is often stronger than normal in people with knee OA, which may be a sign that their nervous system has become more sensitive to pain.
The main questions this study aims to answer are:
- Is this training safe, and what side effects do people have?
- Can people with knee OA complete the training, and do they find it acceptable?
Researchers will compare people who receive real neurofeedback training with people who receive a placebo (inactive) version of the training. In the placebo version, the electrical pulses are too weak to trigger the reflex, and what appears on the screen is not based on the person's own reflex. Comparing the two groups helps researchers tell which parts of taking part are difficult because of the study set-up itself and which are difficult because of the training.
Participants will:
- Visit a research laboratory at Northeastern University in Boston 7 times: one measurement visit lasting about 3 hours, then 6 training visits lasting about 60 to 90 minutes each. Training visits happen about twice a week, with at least 2 days between visits.
- At the measurement visit, have small sensors placed on the head and legs, receive brief electrical pulses to the leg and brief magnetic pulses to the head, and have their sensitivity to pain checked using brief pressure on the kneecaps and wrist.
- At each training visit, receive brief electrical pulses to the leg while watching a screen. People in the neurofeedback group will try to make a bar on the screen smaller. People in the placebo group will watch a screen that does not reflect their own reflex.
- Answer questionnaires about their knee pain and daily activities.
- Receive a phone call and complete a short online survey about 2 weeks after the last training visit.
A smaller group of participants will take part in the measurement visit only. They may not receive neurofeedback or placebo training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FWR Down-Conditioning Neurofeedback | Experimental | Other: FWR Down-Conditioning NeurofeedbackSix sessions of operant down-conditioning of the flexor withdrawal reflex with veridical trial-by-trial EMG feedback. |
| Sham Feedback | Placebo comparator | Other: Sham FeedbackSix sessions with sub-reflex-threshold stimulation and non-veridical feedback. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45 years or older
- Symptomatic knee osteoarthritis meeting the clinical definition in the National Institute for Health and Care Excellence (NICE) guidelines: knee pain for more than 3 months and morning stiffness lasting less than 30 minutes
- Able to speak and understand English
- Able to attend all study visits at the study site in Boston, MA
Key exclusion criteria (24 listed)
- Stimulation safety
- Pacemaker, implanted defibrillator, or other implanted electronic device
- Metal implants in the head
- Implants in the lower limb, including prior knee arthroplasty
- History of seizures or 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 |
|---|---|---|
| FWR Down-Conditioning NeurofeedbackParticipants receive trial-by-trial feedback of flexor withdrawal reflex amplitude. | Other | FWR Down-Conditioning Neurofeedback |
| Sham FeedbackParticipants receive sham trial-by-trial feedback of flexor withdrawal reflex amplitude. The placebo condition is matched on instrumentation, session structure, stimulation triggering, and visit burden, and differs in stimulation intensity and in whether displayed feedback derives from the participant's own reflex. | Other | Sham Feedback |
Primary outcome
Incidence of adverse events
Time frame: Enrollment through 14 days after the final intervention session (approximately 6 weeks)
Number of participants with at least one adverse event and total event count, characterized by nature, severity, relationship to study procedures, and timing. Serious adverse events reported separately.
Number of participants completing the intervention protocol
Time frame: Randomization through final intervention session (approximately 4 weeks)
Participants completing all 6 intervention sessions, as a proportion of those randomized. Reasons for discontinuation recorded.
Percentage of scheduled intervention sessions attended
Time frame: Intervention period (approximately 3 weeks)
Sessions attended as a proportion of sessions scheduled, across all randomized participants.
Adherence to the intervention protocol
Time frame: Intervention period (approximately 3 weeks)
Proportion of prescribed conditioning stimulations completed per session (225 across 3 blocks of 75), and sessions completed without protocol deviation.
Participant-reported acceptability of the intervention
Time frame: Week 2, Week 3, and Week 5
Survey ratings of usefulness, ease of use, and burden, with identification of most and least helpful components and reasons for non-completion.
Screening and enrollment yield
Time frame: Duration of recruitment (approximately 30 months)
Number screened, number eligible, number enrolled, and number declining, with reasons for ineligibility and declination.
13 secondary outcomes
Change in flexor withdrawal reflex amplitude
Time frame: Week 1 through Week 3
Pain severity
Time frame: Week 1, Week 3, and Week 5
Pressure pain threshold
Time frame: Baseline (Day 1), then Week 1 through Week 3
Temporal summation of pain
Time frame: Baseline (Day 1)
Pain-related evoked potential (PREP) amplitude
Time frame: Baseline (Day 1)
Somatosensory-evoked potential (SSEP) amplitude
Time frame: Baseline (Day 1)
Short-afferent inhibition
Time frame: Baseline (Day 1)
Conditioned pain modulation
Time frame: Baseline (Day 1)
Difference in pain intensity between experimentally evoked and real-world movement-evoked pain
Time frame: Baseline (Day 1)
Difference in WOMAC pain subscale score between experimentally evoked and real-world movement-evoked pain
Time frame: Baseline (Day 1)
Difference in SF-MPQ-2 total score between experimentally evoked and real-world movement-evoked pain
Time frame: Baseline (Day 1)
Change in KOOS Pain subscale score
Time frame: Baseline (Day 1), Week 3, and Week 5
Change in ICOAP total score
Time frame: Baseline (Day 1), Week 3, and Week 5.
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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual-level data will be shared in accordance with the NIH Data Management and Sharing Plan approved under award 1K23HD118599. Shared data will include neurophysiological recordings (EMG, EEG-derived evoked potentials, TMS-derived measures), quantitative sensory testing values, and individual-level outcome and demographic data, together with associated data dictionaries and metadata. Direct identifiers will be removed and record identifiers replaced with newly generated codes with no retained crosswalk before any dataset is shared.
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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.
David A Sherman, DPT principal investigator
Northeastern University
Questions about this trial
What is this clinical trial studying?
A study testing FWR Down-Conditioning Neurofeedback in people with Knee Osteoarthritis, run by Northeastern University.
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 4 inclusion and 24 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact David A Sherman, PhD (401-225-1233, da.sherman@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Enrollment through 14 days after the final intervention session (approximately 6 weeks)). The study lists 6 primary outcomes in all. 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 22 Sep 2026.