Tens and Rocabado Exercises on TMJ Dysfunction

Head and Neck Cancer Clinical Trial

— TMJ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897983
• Other study ID #: 782015
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: March 21, 2024

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: rana elattar, master
• Phone: 01063633696
• Email: ranaelattar[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 1. Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur . 2. 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. 3. 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. 1. Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur . 2. 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. 3. 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. 1. Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur . 2. 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. 3. Massaging for masseter, temporalis ,Sternocleidomastoid, medial and lateral petrigoid muscles for 2 minutes for each muscle.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Rocabado exercises plus TENS device
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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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