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临床试验/NCT05868460
NCT05868460已完成不适用

Impact of High Intensity Laser Therapy on Temporomandibular Joint Disorders After Head and Neck Cancer.

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The aetiology of TMD is multifactorial and complex.

详细描述

It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, either as a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumours may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.

High intensity laser therapy (HILT) is a non-invasive and painless treatment method. The latest studies have reported the beneficial effects of neodymium-doped yttrium aluminum garnet (Nd: YAG) laser therapy in patients with pain. The advantage of HILT over low level laser therapy (LLLT) is that HILT is able to penetrate and stimulate wider and/or deeper areas; thus, considerably more energy may be transmitted to tissue during HILT therapy compared to LLLT.

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients will be diagnosed by an experienced oral and maxillofacial surgeon.
  • Patients with 20 to 60 years old.
  • 6 months after ending radiotherapy.

排除标准

  • Patients with implants.
  • Current metastasis.
  • Continuing radiotherapy.
  • Pregnant females.
  • Sensitivity to phototherapy.
  • Bells palsy.
  • Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.
  • Subjects who received analgesics or antidepressants.

结局指标

主要结局

Pain intensity

时间窗: 4 weeks

It will be measured by visual analogue scale. It starts with no pain at the left side and gradually increasing pain towards the end of the line at the right side (0-10) and high scores indicate greater pain.

次要结局

  • Quality of life (Oral health Impact Profile)(4 weeks)
  • Muscle power assessment(4 weeks)
  • Functional disability(4 weeks)
  • Range of motion(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Cairo University

研究点 (2)

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