Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- catastrophizing
研究概览
简要总结
Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be diagnosed as suffering from fibromyalgia,
- •present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint,
- •be over 18 years old,
- •understand Spanish and/or Catalan correctly,
- •and read and accept the informed consent form
排除标准
- •history of trauma or recent surgery to the head, face or neck;
- •systemic, rheumatic or central nervous system diseases;
- •diagnosis of malignant tumors or cancer in the orofacial region;
- •participate in other studies at the same time.
结局指标
主要结局
catastrophizing
时间窗: From enrollment to the end of treatment at 6 weeks
The Pain Catastrophizing scale (PCS), evaluates the degree og catastrophic thinking gdue to pain.It is a 13-item scale, with a total range from 0 to 52. Higher scores are associated with a greater degree of pain catastrophizing.
functional limitation
时间窗: From enrollment to the end of treatment at 6 weeks
evaluated with tue short version of the Jaw functional limitation scale (JFLS-8). Evaluates the functional status of the masticatory system. Questionnaire with 8 items, each with a scale from 0 to 10. A higher score suggests a greater limitation.
functional status, disability and pain
时间窗: From enrollment to the end of treatment at 6 weeks
collected in the craniofacial pain and disability inventory (CFPDI). Self administered questionnaire of 21 items. Each item is scored on a Likert scale from 0 to 3.
pain and tinnitus
时间窗: From enrollment to the end of treatment at 6 weeks
evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
myofascial trigger points
时间窗: From enrollment to 4 weeks
presence of a palpable tight band, presence of a hyperirritable tenderpoint within te tight band, local twitch response elicited by acute palpation of the tight band, and presence refered pain in response ot trigger point compression.
Range of motion
时间窗: From enrollment to 4 weeks
measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.
次要结局
未报告次要终点
研究者
Llanos de la Iglesia
Principal investigator
Universitat de Lleida