Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.
详细描述
Design: randomized clinical trial. Objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (FMS).
Background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with FMS are controversial. Descriptive data and intervention studies are still scarce.
Methods and measures: sixty patients will be randomly assigned to experimental or control group. The experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). Pain levels, impact of FMS symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups independent Student t-test for continuous data and χ2 tests of independence for categorical data. Separate 2x2 mixed model ANCOVAs with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia syndrome.
- •Agreement to attend evening therapy sessions.
- •A chief complaint of acute pain (duration <6 months) in the temporomandibular joint on at least one side.
- •The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
排除标准
- •History of recent trauma.
- •Therapeutic co-interventions during treatment.
- •Indication for surgical treatment of temporomandibular joint.
- •Edentulism.
- •Physical or mental illness that precludes attendance at therapy sessions.
结局指标
主要结局
Pain Intensity
时间窗: At baseline and 12 weeks
The visual analog scale (VAS), designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 for pain-free and 100 for maximum pain.
次要结局
- Temporomandibular Dysfunction.(At baseline and 12 weeks)
- Quality of Life (SF-36)(At baseline and 12 weeks)
- Index of Widespread Pain and Symptom Severity(At baseline and 12 weeks)
- Physical Function.(At baseline and 12 weeks)
- Quality of Sleep.(At baseline and 12 weeks)
- Rates of Depression(At baseline and 12 weeks)
- State-Trait Anxiety.(At baseline and 12 weeks)
研究者
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria