Efficacy of a Physiotherapy Protocol Based on Manual Therapy in Patients With Temporomandibular Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intensity of pain
研究概览
简要总结
Objective: To evaluate the efficacy of a manual therapy protocol composed of articulatory and myofascial techniques in patients with temporomandibular dysfunction (TMD).
Methods: Randomized and controlled clinical study of patients presenting TMD. The subjects will be divided into 2 groups: 1) manual therapy group; 2) control group. There will be 4 treatment sessions during 4 weeks, with evaluations before and after the study, which include: severity of dysfunction (Helkimo Index), quality of life (Short Form 36 Health Survey), pressure pain threshold (algometer) ), cervical mobility (goniometer), mouth opening (caliper), pain intensity (Visual Analogue Scale) and cervical disability (Neck Disability Index).
详细描述
Introduction. Temporomandibular dysfunction (TMD) is the set of clinical manifestations that affect this joint, the masticatory muscles and the structures associated with and involved in TMJ movements. This dysfunction represents a subclassification of musculoskeletal disorders, and presents with different symptoms and signs that include pain in the jaw joint or in the tissues that surround it, generalized myofascial pain, crackling or crackling joint noise associated with the movement, decrease in joint range, functional limitation, and deviation to the opening of the jaw.
Objective. The main objective of this study is to compare the efficacy of a myofascial soft tissue treatment versus a control group in people diagnosed with TMD of myofascial origin.
Material and methods
Sample. Subjects with dagnosis of TMD according to the diagnostic criteria for the investigation of temporomandibular disorders.
Study design. Randomized clinical trial with 2 groups: Group 1. Manual therapy protocol of SOFT TISSUES; Group 2. Regular treatment control.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with TMD or myofascial pain according to the Helkimo index.
- •Use of the discharge splint, except in the 2 weeks prior to the study.
- •Age of the subjects between 18 and 65 years old.
- •Presence of TMD signs and symptoms in the 3 months prior to the study, such as limitations in movements, pain and / or deviation during opening of the mouth, muscular sensitivity, and sounds produced by the joint during opening of the mouth.
- •Limitation of active vertical opening of the mouth <40 mm.
- •Bilateral pain that surrounds the areas of the temporal and the masseter.
- •Presence of at least one trigger point in the masseter and temporal muscles.
- •Patients who sign the informed consent.
排除标准
- •That they did not use the splint, except in the 2 weeks prior to the study.
- •Presence of systemic, rheumatic or central nervous system diseases.
- •Trauma or previous surgical intervention in the ATM region.
- •History of some type of treatment (physiotherapy or acupuncture) in the 3 months prior to the study.
- •Use of analgesics or muscle relaxants at least 24 hours before the evaluations and during the treatment period.
- •Presence of another type of orofacial pain disorder.
- •Presence of signs or symptoms of disc displacement, osteoarthritis or TMJ arthritis.
- •Positive extension-rotation test (vertebral artery test or Klein test) or cerebrovascular changes.
研究组 & 干预措施
Manual therapy
Protocol of soft tissue techniques
干预措施: Regular treatment control. (Other)
Regular treatment control.
Regular treatment control.
干预措施: Manual therapy (Other)
结局指标
主要结局
Intensity of pain
时间窗: 8 weeks
Pain intensity scale. This scale consists of a horizontal line of 100 mm, delimited at one end by 0 mm (no pain) and at the other end by 100 mm (worst pain imaginable). This scale has shown a high validity and reliability for the assessment of the pain intensity of the patient
次要结局
- Severity and degree of dysfunction(8 weeks)
- Opening range of the mouth(8 weeks)
- Cervical disability(8 weeks)
- Cervical mobility(8 weeks)
- Health status(8 weeks)
- Pressure pain threshold(8 weeks)
研究者
GEMMA V ESPÍ LÓPEZ, PhD
Principal Investigator
University of Valencia