Neurofeedback for Pain Sensitization in Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorNortheastern University
About this trial
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:
1. Is this training safe, and what side effects do people have? 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
FWR Down-Conditioning Neurofeedback
Other interventionParticipants receive trial-by-trial feedback of flexor withdrawal reflex amplitude.
Sham Feedback
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: FWR Down-Conditioning NeurofeedbackExperimental treatment 1 intervention
Group B: Sham FeedbackPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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 32
Pain severity
Knee pain rated on a visual analog scale.
Time frame
Week 1, Week 3, and Week 53
Pressure pain threshold
Algometry at the patellae and wrist.
Time frame
Baseline (Day 1), then Week 1 through Week 34
Temporal summation of pain
Change in pain rating across repeated weighted pinprick stimuli.
Time frame
Baseline (Day 1)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northeastern University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
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