Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Temporomandibular joint pain Temporomandibular joint pain
研究概览
简要总结
The aim of this study is to assess the effects of radial shock wave therapy in the treatment of temporomandibular joint syndrome. For this objective, subjects recruited will be allocated in an experimental group or a placebo group. Both groups will receive one manual therapy and radial shock waves therapy (real for experimental group, a sham device for placebo group) session per week along one month. Pain, neck function and quality of life measured will be performed before the intervention, after the last treatment and at one month follow-up.
详细描述
Temporomandibular Disorders (TMDs) are a subgroup of painful orofacial disorders of the stomatognathic system, characterized by TemporoMandibular Joint (TMJ) pain, fatigue of the cranio-cervico-facial muscles (especially the masticatory muscles), limitation of mandibular movement and the presence of a click or crackling sound in the ATM.
The main signs and symptoms associated with TMDs are bruxism (33%), myofascial pain (14%), headache (96%) and functional limitation (93%), the latter being related to posture.
The quality of life of patients with TMD involvement is diminished in various facets of their lives, leading to a private expense for the patient as well as a public expense resulting from a poor referral due to the lack of adequate treatment for TMDs. This expense ranges in Spanish public hospitals at € 146.9 with a minimum of € 52 and a maximum of € 425.
From this study, we are going to carry out a non-invasive, analgesic, anti-inflammatory treatment and without negative side effects for the patient through radial extracorporeal shock waves (rESWT), and manual therapy (TM).
Among the effects produced by shock waves we find that they improve circulation due to increased blood flow and oxygenation, at tissue level the permeability of the membrane increases and its metabolic process, therefore facilitating the activation of tissue regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle relaxation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will take and opaque enveloped who revealed the allocation group (named as RED or BLUE for blindness conditions). Investigators will not be aware of the which device is sham or real treatment due to codification. The outcomes assessor will be a different person from the investigator and the care providers, unaware of group allocation and treatment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed of temporomandibular disorder by medical doctor.
排除标准
- •Subjects who due to their own characteristics are not able to carry out the study tests
结局指标
主要结局
Temporomandibular joint pain Temporomandibular joint pain
时间窗: At two months
Actual local pain at temporomandibular joint measured with Numerical pain rating scale
Temporomandibular joint pain
时间窗: At one month
Actual local pain at temporomandibular joint measured with Numerical pain rating scale
Neck function
时间窗: At two months
Neck Disability Index, a 10 questions scale about neck function
次要结局
- Dizziness(At two months)
- Quality of life Measured with SF-12(At two months)
- Headache impact in quality of life(At two months)
- Pain threshold(At two months)
- Temporomandibular joint function(At two months)
研究者
Alfonso Javier Ibáñez-Vera
Health Sciences Department Professor
University of Jaén