Effect Of A 6-week Multimodal Physiotherapy Programme Versus Occlusal Splint Therapy On Pain, Mouth Opening And Quality Of Life In Adults With Muscular Temporomandibular Disorders: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Pain Intensity (Numeric Pain Rating Scale - NPRS)
研究概览
简要总结
The aim of this study is to compare the effects of two therapeutic approaches commonly used in the management of muscular temporomandibular disorders (TMD): a multimodal physiotherapy program combining manual therapy and therapeutic exercises, and the use of an occlusal splint during sleep.
This study seeks to determine whether these interventions help reduce pain, improve mouth opening, and enhance oral health-related quality of life in adults with muscular TMD.
Participants will be assigned to one of two groups: one group will receive a six-week multimodal physiotherapy program, while the other will use an occlusal splint nightly for the same period.
Assessments will be conducted at baseline and 48 hours after completion of the intervention. The findings of this study may contribute to improving clinical management and treatment strategies for individuals with TMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes;
- •Aged 18-50 years;
- •Diagnosis of muscular temporomandibular disorders (TMD) with restricted mouth opening according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD);
- •Signed informed consent.
排除标准
- •Use of orthodontic appliances;
- •History of facial trauma;
- •Intake of anti-inflammatory drugs or analgesics within 48 hours prior to data collection;
- •Presence of arthritis, rheumatoid disease, ankylosing spondylitis, or Bell's palsy.
研究组 & 干预措施
Multimodal Physiotherapy
Participants received a multimodal physiotherapy program consisting of one 30-minute session per week for six weeks, delivered by a trained physiotherapist. The intervention included manual therapy techniques targeting the masticatory muscles combined with strengthening and motor coordination exercises.
干预措施: Multimodal Physiotherapy (Behavioral)
Occlusal Splint
Participants received thermoplastic occlusal splint therapy (3 mm thickness) and were instructed to wear the device nightly during sleep for six consecutive weeks. Splint fitting and occlusal adjustments were performed by a qualified dentist.
干预措施: Occlusal Splint (Device)
结局指标
主要结局
Pain Intensity (Numeric Pain Rating Scale - NPRS)
时间窗: Baseline and 6 weeks (48 hours after completion of the intervention).
Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their worst pain during daily activities in the previous 24 hours.
次要结局
- Pressure Pain Threshold - PPT (Algometry)(Baseline and 6 weeks (48 hours after completion of the intervention).)
- Mouth Opening Amplitude (Digital Caliper)(Baseline and 6 weeks (48 hours after completion of the intervention).)
- Oral Health-Related Quality of Life (OHIP-14)(Baseline and 6 weeks (48 hours after completion of the intervention).)
研究者
Inês Gomes
Principal Investigator
Egas Moniz - Cooperativa de Ensino Superior, CRL