An interventional study of FWR Down-Conditioning Neurofeedback and Sham Feedback in Knee Osteoarthritis, sponsored by Northeastern University. Not yet recruiting. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Northeastern University · Not applicable, Interventional, and Other
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:
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:
A smaller group of participants will take part in the measurement visit only. They may not receive neurofeedback or placebo training.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Northeastern University is the lead sponsor of 55 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Stimulation safety
Neurological, psychiatric, and medical
Pain and musculoskeletal
Skin and sensation at stimulation sites
Substances
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.
Six sessions of operant down-conditioning of the flexor withdrawal reflex with veridical trial-by-trial EMG feedback.
Other: FWR Down-Conditioning Neurofeedback
Six sessions with sub-reflex-threshold stimulation and non-veridical feedback.
Other: Sham Feedback
Participants receive trial-by-trial feedback of flexor withdrawal reflex amplitude.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of recruitment (approximately 30 months)
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.
Time frame: Week 1 through Week 3
Pain severity
Knee pain rated on a visual analog scale.
Time frame: Week 1, Week 3, and Week 5
Pressure pain threshold
Algometry at the patellae and wrist.
Time frame: Baseline (Day 1), then Week 1 through Week 3
Temporal summation of pain
Change in pain rating across repeated weighted pinprick stimuli.
Time frame: Baseline (Day 1)
Pain-related evoked potential (PREP) amplitude
Peak-to-peak amplitude of pain-related evoked potentials.
Time frame: Baseline (Day 1)
Somatosensory-evoked potential (SSEP) amplitude
Peak-to-peak amplitude of somatosensory evoked potentials.
Time frame: Baseline (Day 1)
Short-afferent inhibition
Conditioned motor evoked potential amplitude expressed relative to unconditioned response.
Time frame: Baseline (Day 1)
Conditioned pain modulation
Change in pressure pain threshold during cold water immersion.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1), Week 3, and Week 5.
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: No later than the time of publication of the associated primary findings, or by the end of the award period of performance, whichever occurs first.
Access criteria: Neurophysiological data will be openly accessible through the designated repository. Individual-level clinical and outcome data will be available to qualified investigators under a data use agreement.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2030, 45 months later.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 45 months is above that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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