The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals with Temporomandibular Disorders: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Jaw Functional Limitation Scale - 8 item (JFLS-8)
研究概览
简要总结
The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders (TMD) is to determine whether standard care plus 6-weeks of tailored, individualized physical therapy (PT) treatment provides greater benefit than standard care alone in patient-reported outcomes, and maximal mouth opening.
The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0-, 6-, and 12-weeks. The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes, and maximal mouth opening compared to those who received standard care alone.
Additionally, the investigators will compare the amount and type of healthcare utilization between the two groups (Standard Care and Standard Care + PT) in the 12-month period following enrollment in the study.
All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider. All participants will complete patient-reported outcome measures and have their jaw motion measured. Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks.
详细描述
The following procedures will be conducted once the subject has signed and received their informed consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
Inclusion/exclusion will be reviewed (including the TMD Pain Screener). Subjects will then be provided with research questionnaires and patient-reported outcome measures for completion. All outcomes will be obtained through direct interaction with subjects.
Subjects will then undergo measurements for pain-free mouth opening and maximal mouth opening (MMO) ranges of motion. All subjects will undergo the same measurement protocol.
Following the above measures, subjects will then be randomized into one of two parallel treatment arms, standard care (control group), or standard care + PT interventions (experimental group). The groups are further described below. The method of group assignment will be sequentially numbered opaque sealed envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next eligible subject, randomization will be performed in permuted blocks of 2 or 4 with random variation of the blocking number. Due to the nature of the study, it is not possible to blind the subjects or the clinician providing the intervention to the treatment received. Assessors will be blinded to group allocation, and clinicians will be blinded to outcomes.
After randomization, enrolled subjects who have already received care from a dental provider will continue with their dental provider for routine TMD care. Any enrolled subjects not being seen by a dental provider for their TMD concerns will be referred to the prosthodontist associated with this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active-Duty Service Members
- •Complaint of TMD symptoms
- •Must be able to be followed for twelve weeks after consent
- •TMD Screener score ≥ 3 45
排除标准
- •Actively in a Trainee status
- •Utilized oral device in past 6 months
- •Facial injection therapy in the prior 6 months
- •Facial surgery in the preceding 6 months
- •Serious spinal pathology (acute fracture, active cancer, instability)
- •Diagnosed neurological or rheumatological disease
- •Currently under litigation related to temporomandibular or cervical spine pain(s)
- •Currently undergoing Medical Evaluation Board (MEB)
- •Retiring or separating from the military within a year
结局指标
主要结局
Jaw Functional Limitation Scale - 8 item (JFLS-8)
时间窗: From enrollment to 12 weeks post enrollment (primary), will also be assed at 6-weeks
This study's primary outcome variable is the Jaw Functional Limitation Scale - 8 Item version. This 8-item questionnaire is scored from 0 to 80 points, with higher scores indicating greater levels of functional limitation. The JFLS-8 is a reliable and valid tool to measure patient functional limitations related to the jaw. This questionnaire is supported by the dental and physical therapy communities to measure functional limitations of the jaw. Each item is scored from 0-10. The scores are summed and divided by the number of items answered. No more than two items can be missing for scoring to take place.
次要结局
- Numeric Pain Rating Scale (NPRS)(At enrollment, 6-weeks, and 12-weeks)
- Neck Disability Index (NDI)(Collected at baseline, 6- and 12-weeks.)
- Central Sensitization Inventory (CSI)(Collected at baseline, 6- and 12-weeks.)
- Global Rating of Change (GRoC)(Collected at 6- and 12-weeks)
- Pain-Free Mouth Opening (PFMO)(Collected at baseline, 6- and 12-weeks.)
- Maximal Mouth Opening (MMO)(Collected at baseline, 6- and 12-weeks)
- Healthcare Utilization(Collected at 12-months after enrollment for each subject)
- Patient-Report Outcome Measure Information System (PROMIS-57)(Collected at baseline, 6- and 12-weeks.)
研究者
Mason A Frank
Physical Therapist
Brooke Army Medical Center