Tens and Rocabado Exercises on TMJ Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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). The TENS will be applied for 20 min 3 sessions/week for 8 weeks. Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily. Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur . Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position. Massaging for masseter, temporalis ,Sternocleidomastoid, medial and lateral petrigoid muscles for 2minutes for each muscle. Patients at group B: patients will receive Rocabado exercises 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 min 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. Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily. Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur . Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position. Massaging for masseter, temporalis ,Sternocleidomastoid, medial and lateral petrigoid muscles for 2minutes for each muscle. patients at group C: patient will receive Transcutaneous electrical nerve stimulation device(TENS) and traditional exercises: 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). The TENS will be applied for 20 min 3 sessions/week for 8 weeks. Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily. Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur . Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position. Massaging for masseter, temporalis ,Sternocleidomastoid, medial and lateral petrigoid muscles for 2 minutes for each muscle.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Rocabado exercises plus TENS device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocabado exercises plus TENS<br>Rocabado exercises plus TENS and traditional exercises For 8 weeks,Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises are 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. 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, The TENS will be applied for 20 min 3 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily | Other: Rocabado exercises plus TENS device<br>* Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises 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. 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, The TENS will be applied for 20 min 3 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily<br>|
| Experimental: Rocabado exercises<br>Rocabado 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 . part (2): Joint mobilization) includes Distraction given with anterior glide, with anterior and lateral glide right/left & Lateral glide without distraction. Plus Traditional exercises. | Other: Rocabado exercises plus TENS device<br>* Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises 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. 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, The TENS will be applied for 20 min 3 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily<br>|
| Experimental: Transcutaneous electrical nerve stimulation device<br>TENS is used, 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 are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back ,The TENS will be applied for 20 min 3 sessions/week for 8 weeks. Plus Traditional exercises. | Other: Rocabado exercises plus TENS device<br>* Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises 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. 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, The TENS will be applied for 20 min 3 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| . 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |