Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- The Oral Health Impact Profile for TMD summary score
研究概览
简要总结
This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old
- •Referred to PT with ≥1 TMD subtype diagnosis
- •PI has no previous knowledge of the participant's diagnosis
- •Email access
- •Possession of any device that can be positioned for hands-free TR visits (TR group only)
- •Willingness and ability to comply with all study requirements and PT program
- •Able to provide informed consent
排除标准
- •Non-English speakers
- •Permanent residence outside of the state of Minnesota (TR group only)
- •Women in the last trimester of pregnancy
- •Referred for post-surgical rehabilitation
- •Severe chronic pain as identified by level 4 classification on the GCPS
- •Current diagnosis or existence of the following conditions that can limit response to PT and participation in study activities:
- •Neuropathic pain
- •Fibromyalgia and/or generalized widespread pain on both sides of the body in ≥3 areas above and below the waist
- •Rheumatoid arthritis or juvenile idiopathic arthritis
- •Dystonia or other movement disorder
- •Fractures and/or recent jaw or facial trauma
- •Malignancies
- •Current substance abuse
结局指标
主要结局
The Oral Health Impact Profile for TMD summary score
时间窗: 6 weeks after intervention onset
The OHIP-TMD is a condition-specific quality-of-life scale with 22 items and a 0-4 scoring option for each item. A higher score means lower quality-of life. The summary score after 6 weeks will be compared to the baseline summary score, and a score decrease ≥6.9 units will be considered evidence of therapy success. The proportion of therapy success in each group will be used for non-inferiority comparison.
Specialist diagnosis
时间窗: Measured directly after the PT evaluation (Day 1)
Diagnosis will be determined by putting clinical assessment results into the Brief Diagnostic Criteria for TMD (Brief DC/TMD) algorithm and getting one or more of 7 possible diagnoses: TMJ arthralgia (joint), Masticatory myofascial pain (muscle), TMJ disc displacement with reduction (joint), TMJ disc displacement without reduction (joint), TMJ arthritis (joint), TMD headache (muscle), other (neither). The diagnosis will be measured as one of four options: 1. joint; 2. muscle; 3. both; or 4. neither.
Diagnostic agreement
时间窗: Measured directly after the PT evaluation (Day 1)
Agreement data for each subject will be collected comparing two specialist diagnoses: dentist and physical therapist. Agreement about the diagnostic category will be recorded as a binary "yes/no" measure.
次要结局
未报告次要终点