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临床试验/NCT05897983
NCT05897983已完成不适用

Efficacy of Transcutaneous Electrical Nerve Stimulation Plus Rocabado Exercises on Temporomandibular Joint Dysfunction After Head and Neck Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年9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
72
试验地点
1
主要终点
. Vernier caliper:

研究概览

简要总结

72 patients who suffers from limited mouth opening and pain in the temporomandibular joint will be selected from oncology department in Zagazig and Cairo university hospitals: patients will be assigned randomly into three groups equal in number, 24 in each group: (group A) will receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional exercises .(group B) will receive Rocabado exercises and traditional exercises.(groub C) will receive transcutaneous electrical nerve stimulation and traditional exercises.

详细描述

Patients at group A: patients will receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional exercises For 8 weeks : Rocabado exercises form of 2 parts , 6×6×6 exercises and mobilization exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue , (2). Shoulder retraction exercises, (3). Stabilized head flexion ,( 4). The axial extension of the neck , (5).Control of TMJ rotation , (6).Rhythmic stabilization technique .these 6 exercises are repeated 6 times a day for 20 minutes for each repetition.

part (2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction given with anterior glide, Distraction given with anterior and lateral glide right/left & Lateral glide without distraction. . These mobilization exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times.

Transcutaneous electrical nerve stimulation device(TENS):

TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds.

TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back (Cacho et al.,2022).

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

入选标准

  • The subject selection will be according to the following criteria:
  • Age range between 40-60 years.
  • Male and female patients will participate in the study.
  • All patients undergo head and neck cancer surgeries (oral cancer surgeries).
  • All patients will start treatment within 6 months of radiotherapy termination.
  • All patients have pain in different degrees.
  • Restricted range of mouth opening < 35 mm.
  • All patients enrolled to the study will have their informed consent.

排除标准

  • The potential participants will be excluded if they meet one of the following criteria:
  • Other morbid conditions in the temporomandibular region as rheumatic diseases and neurological diseases.
  • Presence of other disorders involving the TMJ (e.g., myalgia, degenerative joint disease, or collagen vascular disease).
  • Arthritis.
  • Fracture around Temporomandibular Joint (TMJ).
  • Dislocation or subluxation of TMJ.
  • Inflammatory disorders of TMJ.

结局指标

主要结局

. Vernier caliper:

时间窗: 8 weeks

The vernier, dial, and digital calipers give a direct reading of the distance measured with high accuracy . Vernier calipers commonly used in industry provide a precision to 0.01 mm (10 micrometres), or one thousandth of an inch. They are available in sizes that can measure up to 1,829 mm (72 in) (Agrawal et al., 2015).

Mandibular Function Impairment Questionnaire:

时间窗: 8 weeks

The Mandibular Function Impairment Questionnaire is used to assess the limitation of oral function due to mandibular function impairment. Subjects will compelete this self-reported questionnaire that comprise 17 items encompassing the difficulty of chewing hard and soft foods, taking large bites, laughing, eating certain foods, engaging in social activity, and speaking. The items are scored on a 5-point Likert scale (0-4). The overall score is calculated by dividing the sum of the item scores by 68, with a possible range of 0 to 1. A higher score denotes a more serious functional impairment. An overall score of ≤0.3 denotes a low degree, 0.3 ≤ 0.6 denotes a moderate degree, and \>0.6 denotes a high degree of functional impairment( Stegenga et al.,1993).

次要结局

  • Visual Analogue Scale:(8 weeks)

研究者

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

Rana Mohamed Mohamed Elattar

master, Assistant lecturer of physical therapy.

Cairo University

研究点 (1)

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