Head and Neck Cancer Clinical Trial
— TMJOfficial title:
Efficacy of Transcutaneous Electrical Nerve Stimulation Plus Rocabado Exercises on Temporomandibular Joint Dysfunction After Head and Neck Surgeries
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | March 21, 2024 |
Est. primary completion date | February 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: - The subject selection will be according to the following criteria: - Age range between 30-60 years. - Male and female patients will participate in the study. - All patients undergo head and neck cancer surgeries (oral cavity, tongue, oropharyngeal cancer, nasopharyngeal cancer, hypo pharyngeal cancer, maxillary sinus cancer, tumor colli and parotid gland tumors). - All patients will start treatment after 2 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Physical Therapy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | . Vernier caliper: | 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). | 8 weeks | |
Primary | Mandibular Function Impairment Questionnaire: | 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). | 8 weeks | |
Secondary | Visual Analogue Scale: | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points, zero mean no pain and 10 mean sever pain (Reips and Funke,2008). | 8 weeks |
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