Effects of Pilates On Women With Myogenic Temporomandibular Joint Dysfunction; A Randomised Controlled, Single-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Masseter muscle Pressure-Pain Threshold (PPT)
研究概览
简要总结
The aim of this study is to investigate the effects of an 8-week Pilates exercise program on pain, pressure-pain threshold, temporomandibular joint (TMJ) range of motion, cervical posture, stress levels, quality of life, jaw function and disability, depression, and muscle stiffness in women with myogenic temporomandibular disorders (TMD).
Eligible volunteers will be recruited from Toros University students and staff through screening with the Fonseca Anamnestic Index and diagnostic criteria for TMD (DC/TMD Axis I). After informed consent, participants who meet the inclusion criteria will be randomly assigned to either a control or an intervention group.
Control Group: Receives patient education (including information about parafunctional habits and sleep hygiene) and a standardized home exercise program to be performed three times per week for eight weeks. Compliance will be monitored weekly by phone calls and exercise logs.
Intervention Group: Receives the same education and home exercise program plus supervised Pilates training, three sessions per week for eight weeks, each lasting approximately 60 minutes (including warm-up and cool-down). Sessions are delivered by a certified physiotherapist and structured progressively every two weeks.
All participants will undergo a comprehensive baseline and post-intervention assessment by a blinded evaluator. Assessments include:
Pressure-pain threshold (digital algometer) at masseter, trapezius, and tibialis anterior muscles
Temporomandibular joint range of motion (TheraBite scale)
Cranio-cervical posture (photogrammetry and ImageJ analysis)
Pain intensity and disability (Visual Analog Scale, Graded Chronic Pain Scale)
Jaw function and limitation (JFLS-8)
Quality of life (SF-36)
Depression and anxiety levels (PHQ-4)
Muscle stiffness (MyotonPRO)
Salivary cortisol analysis for stress evaluation
Participants are excluded if they have systemic, neurological, psychiatric, or dental conditions; recent orthodontic treatment or trauma; ongoing use of pain medication; prior Pilates training in the past six months; or other factors that may affect assessment outcomes.
Data will be analyzed using SPSS (v26) with appropriate parametric and non-parametric tests, and statistical significance will be set at p<0.05. The study is designed as a single-blind, randomized controlled trial and will provide evidence on whether Pilates can be recommended as a complementary therapy in the management of myogenic TMD.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-50 years
- •Diagnosed with myogenic temporomandibular disorder (TMD) based on standardized, valid, and reliable Diagnostic Criteria for TMD (DC/TMD Axis I)
- •Presence of TMD-related symptoms for at least the past 6 months
- •Resting pain intensity of ≥3 on the Visual Analog Scale (VAS)
- •No regular participation in physical activity within the past 6 months
- •Having natural dentition, defined as at least 10 natural teeth in both upper and lower jaws, confirmed by dental examination
排除标准
- •Having received treatment related to TMD within the past year
- •Needing dental treatment due to caries or periodontal disease
- •Currently undergoing orthodontic treatment
- •Having removable or fixed partial dentures
- •Presence of other orofacial disease symptoms such as migraine or toothache
- •Using a myorelaxant splint
- •Having major psychosocial problems according to DC/TMD Axis II
- •Having alcohol or drug addiction
- •Being diagnosed with or receiving treatment for any psychiatric disorder
- •Participation in Pilates sessions within the past 6 months
- •Being pregnant
- •Regular use of pain or anti-inflammatory medication
- •Having systemic, rheumatic, endocrine, or connective tissue diseases
- •History of trauma or surgery to the upper extremity, neck, orofacial region, or -head
- •Presence of joint damage in the upper extremity, neck, orofacial region, or head
研究组 & 干预措施
Pilates
Participants in the experimental group will receive supervised Pilates training three times per week for eight weeks in addition to the patient education and home exercise program provided to the control group. They will first attend an introductory session covering core stabilization, pelvic alignment, breathing, and key Pilates principles, which they will be instructed to maintain throughout the exercises. Each 60-minute session will include a warm-up, progressive Pilates exercises performed in 3 sets of 10 repetitions, and a cool-down phase, with new movements introduced in weeks 3, 5, and 7. Exercises will be demonstrated, monitored, and corrected by a physiotherapist using verbal, tactile, and visual feedback.
干预措施: Pilates (Other)
Control
Participants in the control group will receive patient education on avoiding parafunctional habits and maintaining proper sleep hygiene, along with a standardized home exercise program. The home program will include heat application, self-massage, jaw stretching, strengthening exercises, and Rocabado 6x6 exercises. They will be instructed to perform these exercises three times per week for eight weeks and will be contacted weekly to monitor compliance. An exercise log will be provided and collected at the end of the intervention period.
干预措施: Education and home exercise (Other)
结局指标
主要结局
Masseter muscle Pressure-Pain Threshold (PPT)
时间窗: Baseline: week 0 / At the end of Week 8: Second and final assessment
Pressure-pain threshold will be measured using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). Assessments will be performed bilaterally on the masseter muscles to evaluate regional pain sensitivity. After a practice trial, pressure will be applied with a 1 cm² probe at a rate of 1 kg/cm² per second until participants indicate the onset of pain, and the average of three trials taken 30 seconds apart will be recorded in kg/cm².
Upper Trapezius Pressure-Pain Threshold
时间窗: Baseline: week 0 / At the end of Week 8: Second and final assessment]
Pressure-pain threshold will be measured using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). Assessments will be performed bilaterally on the uper trapezius muscles to evaluate regional pain sensitivity. After a practice trial, pressure will be applied with a 1 cm² probe at a rate of 1 kg/cm² per second until participants indicate the onset of pain, and the average of three trials taken 30 seconds apart will be recorded in kg/cm².
Tibialis Anterior Muscle Pressure-Pain Threshold
时间窗: Baseline: week 0 / At the end of Week 8: Second and final assessment
Pressure-pain threshold will be measured using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). Assessments will be performed bilaterally on the masseter muscles to evaluate regional pain sensitivity. After a practice trial, pressure will be applied with a 1 cm² probe at a rate of 1 kg/cm² per second until participants indicate the onset of pain, and the average of three trials taken 30 seconds apart will be recorded in kg/cm².
次要结局
- Temporomandibular Joint Range of Motion(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Cranio-cervical posture(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Quality of life (QoL)(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- TMJ Pain(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Jaw Limitation(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Depression(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Muscle Stiffness(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Logarithmic decrease(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Stress hormon levels(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Cervical Pain(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- Anxiety Levels(Baseline: week 0 / At the end of Week 8: Second and final assessment)
- TMJ Dysfunction Severity(Baseline: week 0 / At the end of Week 8: Second and final assessment)