Patient Education, Self-management and Physiotherapy in the Management of Chronic Painful Temporomandibular Disorders : a Two-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Characteristic Pain Intensity (CPI)
研究概览
简要总结
The goal of this clinical trial is to understand whether a simple education and self-management program with home exercises can reduce pain and improve daily function in adults with long-lasting jaw pain caused by temporomandibular disorders (TMD) as much as a more intensive hands-on physiotherapy approach.
The main questions it aims to answer are:
- Does an education and self-management exercise program reduce jaw pain, improve jaw function and reduce how much pain interferes with daily activities?
- Does this program improve outcomes similarly to the usual treatment for TMDs, which includes also manual therapy and supervised exercise sessions?
Researchers will compare an education and self-management program with home exercises to usual physiotherapy care to see which approach leads to better pain relief and daily functioning over time.
Participants will:
Attend three evaluation visits (at the start of the study, after 6 weeks, and after 16 weeks);
Be assigned to one of two treatment groups:
- A group receiving two physiotherapy-supervised education and self-management sessions with personalized home exercises; or
- A group receiving six physiotherapy usual treatment sessions, which may include education, exercises, and hands-on therapy;
Participants will complete questionnaires about:
Jaw pain, Jaw function, Body pain, Neck disability, Oral behaviors, Pain catastrophizing, Fear of movement, Confidence in managing pain.
Measures of mouth opening will be taken (non-painful, maximal and maximal with assistance) with a ruler at all time points.
This study includes adults aged 18 to 65 years who have jaw pain for at least 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic of painful TMD according to axis 1 of DC/TMD
- •Experiencing rest pain for at least 3 months
- •With a minimum pain intensity of 3 on a 10-point Numeric Pain Rating Scale (NPRS)
排除标准
- •History of jaw surgery
- •Recent trauma to head or jaw
- •Ongoing dental treatment
- •History of rheumatologic condition
- •Severe psychiatric condition (e.g severe anxiety or severe depression)
研究组 & 干预措施
Patient education and self-management
Each of the two sessions will be conducted individually with one of two physiotherapists and will last 45 minutes each. The first session will be used at baseline to deliver proper insights to the patient regarding normal physiology and their TMD, pain pathophysiology using references and visual aids (i.e. video, biomechanical demonstration on human skeleton model) to facilitate understanding. Depending on clinical presentation and scores to self-administered questionnaires, counseling and recommendations will be tailored. Lastly, an exercise program, including self-relief manual techniques and rehabilitation exercises for posture, mobility and strength of the neck and jaw will be demonstrated, practiced and prescribed to the participants (up to 5 exercises). At home, each patient will have access to an informational binder featuring the recommendations and prescribed exercise program to ensure patient's capacity to follow the intended program.
干预措施: Patient education and self-management (Behavioral)
Usual treatment
This group will be offered six (30 min, 1x/week) in-clinic PT-supervised sessions from one of two experienced physiotherapists over a 5-week period. The usual intervention group will receive personalized care tailored to each participant's presentation with the intention of reducing pain, increasing mobility and strength, and optimizing daily function. Care provided will not be standardized and will include a combination of manual therapy techniques, at-home exercises (up to 5 jointly chosen by PTs and participants) and education regarding potential contributing factors to the presenting TMD. Treatments will not only focus on the TMJ, but may also involve treatment for the neck, head and shoulder griddle based on the physiotherapist's expert clinical reasoning. All therapies will be documented for analysis.
干预措施: Usual treatment (multimodal) (Procedure)
结局指标
主要结局
Characteristic Pain Intensity (CPI)
时间窗: From enrollement to the last evaluation (at 16 weeks after the first treatment)
Graded Chronic Pain Scale (version 2.0). This scale measures two subscales : the Characteristic Pain Intensity (CPI) and the Pain Interference. CPI is used to quantify a patient's jaw and face pain experience by averaging three scores from the past 6 months: current pain, average pain, and worst pain, on a 0-10 scale. The final score ranges from 0 to 100, with higher scores indicating more pain.
Pain Interference
时间窗: From enrollement to the last evaluation (at 16 weeks after the first treatment)
Pain Interference (subscale of the GCPS 2.0) is assessed by measuring how pain restricts daily, social, family, and work activities over the past 30 days, using a 0-10 scale. The final score ranges from 0 to 100, with higher scores indicating greater pain interference.
次要结局
- Jaw function(From enrollement to last evaluation (at 16 weeks after the first treatment))
- Body Pain(From enrollment to last evaluation (at 16 weeks after the first treatment))
- Neck disability(From enrollment to last evaluation (at 16 weeks after the first treatment))
- Jaw mobility(From enrollment to last evaluation (at 16 weeks after the first treatment))
- Catastrophizing(From enrollment to last evaluation (at 16 weeks after the first treatment))
- Kinesiophobia(From enrollment to last evaluation (at 16 weeks after the first treatment))
- Self-efficacy(From enrollment to last evaluation (at 16 weeks after the first treatment))
- Oral Behaviors(From enrollement to last evaluation (at 16 weeks after the first treatment))
研究者
François Desmeules
Professor, Researcher, Ph.D
Ciusss de L'Est de l'Île de Montréal