Targeting Pain Sensitization in Knee Osteoarthritis by Conditioning the Endogenous Pain Control System Using Reflex Conditioning.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Incidence of adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
FWR Down-Conditioning Neurofeedback
Six sessions of operant down-conditioning of the flexor withdrawal reflex with veridical trial-by-trial EMG feedback.
干预措施: FWR Down-Conditioning Neurofeedback (Other)
Sham Feedback
Six sessions with sub-reflex-threshold stimulation and non-veridical feedback.
干预措施: Sham Feedback (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: 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
时间窗: 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
时间窗: Intervention period (approximately 3 weeks)
Sessions attended as a proportion of sessions scheduled, across all randomized participants.
Adherence to the intervention protocol
时间窗: 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
时间窗: 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
时间窗: Duration of recruitment (approximately 30 months)
Number screened, number eligible, number enrolled, and number declining, with reasons for ineligibility and declination.
次要结局
- Change in flexor withdrawal reflex amplitude(Week 1 through Week 3)
- Pain severity(Week 1, Week 3, and Week 5)
- Pressure pain threshold(Baseline (Day 1), then Week 1 through Week 3)
- Temporal summation of pain(Baseline (Day 1))
- Pain-related evoked potential (PREP) amplitude(Baseline (Day 1))
- Somatosensory-evoked potential (SSEP) amplitude(Baseline (Day 1))
- Short-afferent inhibition(Baseline (Day 1))
- Conditioned pain modulation(Baseline (Day 1))
- Difference in pain intensity between experimentally evoked and real-world movement-evoked pain(Baseline (Day 1))
- Difference in WOMAC pain subscale score between experimentally evoked and real-world movement-evoked pain(Baseline (Day 1))
- Difference in SF-MPQ-2 total score between experimentally evoked and real-world movement-evoked pain(Baseline (Day 1))
- Change in KOOS Pain subscale score(Baseline (Day 1), Week 3, and Week 5)
- Change in ICOAP total score(Baseline (Day 1), Week 3, and Week 5.)