Tens and Rocabado Exercises on TMJ Dysfunction

NCT ID: NCT05897983

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-05-31

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 2 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 cheeks muscles for 2minutes .

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 cheeks for 2minutes .

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 2 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 cheeks for 2 minutes .

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rocabado exercises plus TENS

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 2 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

Group Type: EXPERIMENTAL

Rocabado exercises plus TENS device

Intervention Type: OTHER

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

Rocabado exercises

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.

Group Type: EXPERIMENTAL

Rocabado exercises plus TENS device

Intervention Type: OTHER

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

Transcutaneous electrical nerve stimulation device

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 2 sessions/week for 8 weeks. Plus Traditional exercises.

Group Type: EXPERIMENTAL

Rocabado exercises plus TENS device

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rana Mohamed Mohamed Elattar

master, Assistant lecturer of physical therapy.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rana elattar, master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

782015

Identifier Type: -

Identifier Source: org_study_id