Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
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
- Change on pain intensity
研究概览
简要总结
The purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies 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 physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome.
Methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. The experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. Pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with independent Student t-test for continuous data and chi-square tests of independence for categorical data. Separate 2x3 model ANOVA with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.
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 (Participant, 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
Change on pain intensity
时间窗: At baseline, 15 weeks and 20 weeks
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
次要结局
- Change in temporomandibular dysfunction(At baseline, 15 weeks and 20 weeks)
- Change in quality of life SF-36(At baseline, 15 weeks and 20 weeks)
- Change on quality of sleep(At baseline, 15 weeks and 20 weeks)
- Change on rates of depression(At baseline, 15 weeks and 20 weeks)
- Change on state-trait anxiety(At baseline, 15 weeks and 20 weeks)
- Change on index of widespread pain and symptom severity(At baseline, 15 weeks and 20 weeks)
- Change in physical function(At baseline, 15 weeks and 20 weeks)
研究者
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria