Comparison of the Effect of Pain Neuroscience Education Combined With Physiotherapy, and Physiotherapy Alone in Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The Craniofacial Pain and Disability Inventory (CF-PDI)
研究概览
简要总结
This research study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) when it is added to a physiotherapy program for people experiencing chronic temporomandibular disorders (TMD). To see whether adding PNE to physiotherapy program would provides additional benefits in reducing pain intensity, improving psychological well-being, and enhancing functional outcomes. The findings are expected to provide new insights into more comprehensive and patient-centered treatment strategies for managing chronic TMD.
Participants will be randomly assigned to one of two groups:
Control Group: Physiotherapy only
PNE Group: Physiotherapy plus Pain Neuroscience Education
Both groups will receive their respective treatments for a set period of time.
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
- None
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
- •Diagnosed with pain-related TMDs according to DC/TMD guidelines
- •Chronic TMD pain, defined as experiencing pain for at least six months and feeling the pain during the last 30 days
- •Age between 18-65 years
排除标准
- •Illiterate patients
- •Severe depression (medical diagnoses)
- •Previous diagnosis of uncontrolled psychiatric disorder neurodegenerative diseases
- •Clinical history of tumors in the craniofacial region
- •Patients in the post dental surgery period
- •Patients who were submitted to previous physical therapy in the past year or to any health/pain education strategy
- •Pregnant women
- •Infections, whiplash-associated disorders and with chronic degenerative inflammatory or neurologic disorders
结局指标
主要结局
The Craniofacial Pain and Disability Inventory (CF-PDI)
时间窗: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up
It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.
The Craniofacial Pain and Disability Inventory (CF-PDI)
时间窗: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up
It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.
次要结局
- Numeric Pain Rating Scale (NPRS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Pain Catastrophizing Scale (PCS)(Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- The Tampa Scale for Kinesiophobia specific to Temporomandibular Disorders (TSK-TMD)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Revised Neurophysiology of Pain Questionnaire (rNPQ)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- The Exercise Adherence Rating Scale (EARS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Fear Avoidance Components Scale (FACS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Numeric Pain Rating Scale (NPRS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Pain Catastrophizing Scale (PCS)(Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- The Tampa Scale for Kinesiophobia specific to Temporomandibular Disorders (TSK-TMD)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Revised Neurophysiology of Pain Questionnaire (rNPQ)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- The Exercise Adherence Rating Scale (EARS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
- Fear Avoidance Components Scale (FACS)(Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up)
研究者
Ainaz Shahedi
MSc Candidate in Physiotherapy, Istanbul Medipol University
Istanbul Medipol University Hospital