Effectiveness of Adding Low Level Laser Therapy to Rocabado's Approach for Myogenic Temporomandibular Joint Disorders: A Double-Blind Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Assessment of Pain pressure threshold of masticatory muscles
研究概览
简要总结
Rocabado's 6x6 exercises are designed to improve muscular co-ordination, relax tense muscles, increase temporomandibular joint (TMJ) ROM, alter the jaw closure pattern and muscle strength. These exercises have been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as restoring restricted joint mobility, muscle length limitation, and postural and functional limitations. In addition, low level laser therapy (LLLT) has been reported to reduce inflammation and pain in patients with TMJ dysfunction. Although that to the best of the authors' knowledge the combined effect of Rocabado's approach with LLLT has not been studied. So, the current study is the first double-blind placebo-controlled clinical trial that investigating the effect of adding LLLT to Rocabado's approach for TMJ myogenic 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) The patient's ages ranged from 18 to 40 years ; (2) having symptoms of TMD for at least twelve weeks duration established by expert physician or orthopaedician; (3) mouth opening < 25mm
排除标准
- •(1) TMJ fracture undergone any surgical procedure for TMJ; (2) Fracture surrounding TMJ; (3) Dislocation or subluxation of TMJ; (4) Systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases or facial paralysis; (5) recently any dental treatment taken or surgery over TMJ; (6) Hematological cervical disorders which may affect the jaw; (7) Neurological deficits e.g. Bells palsy, Trigeminal neuralgia; (8) Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study.
研究组 & 干预措施
study group
干预措施: Rocabado's approach in addition to LLLT (Other)
control group
干预措施: control group (Other)
结局指标
主要结局
Assessment of Pain pressure threshold of masticatory muscles
时间窗: change from base line at 6 weeks.
The pain pressure threshold over the temporalis and masseter muscles will be assessed using an algometer with a 1 cm2 probe tip (FDIX Digital Force Gage; Wagner Instruments).
次要结局
- Assessment of Temporomandibular joint ROM(change from base line at 6 weeks.)
- Assessment of the function of Temporomandibular Joints(change from base line at 6 weeks.)
- Assessment of pain intensity using Numerical Rating Scale(change from base line at 6 weeks.)
研究者
Marwa Shafiek Mustafa Saleh
assistance professor doctor
Cairo University