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Tens and Rocabado Exercises on TMJ Dysfunction (TMJ)

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rocabado exercises plus TENS device
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Rocabado exercises plus TENS

Rocabado exercises

Transcutaneous electrical nerve stimulation device

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

. 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).
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).

Secondary Outcome Measures

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).

Full Information

First Posted
June 1, 2023
Last Updated
September 21, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05897983
Brief Title
Tens and Rocabado Exercises on TMJ Dysfunction
Acronym
TMJ
Official Title
Efficacy of Transcutaneous Electrical Nerve Stimulation Plus Rocabado Exercises on Temporomandibular Joint Dysfunction After Head and Neck Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
February 21, 2024 (Anticipated)
Study Completion Date
March 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rocabado exercises plus TENS
Arm Type
Experimental
Arm Description
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
Arm Title
Rocabado exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous electrical nerve stimulation device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rocabado exercises plus TENS device
Intervention Description
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
Primary Outcome Measure Information:
Title
. Vernier caliper:
Description
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).
Time Frame
8 weeks
Title
Mandibular Function Impairment Questionnaire:
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale:
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rana elattar, master
Phone
01063633696
Email
ranaelattar@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
khadra mohamed, PHD
Phone
01098431152
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rana elattar, master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Tens and Rocabado Exercises on TMJ Dysfunction

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