Tens and Rocabado Exercises on TMJ Dysfunction

NCT05897983 | Completed

• 1 other identifier: 782015
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• . 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 Outcomes (1)

• Visual Analogue Scale:

  8 weeks

Study Arms (3)

Rocabado exercises plus TENS

EXPERIMENTAL

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

Other: Rocabado exercises plus TENS device

Rocabado exercises

EXPERIMENTAL

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

Transcutaneous electrical nerve stimulation device

EXPERIMENTAL

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.

Other: Rocabado exercises plus TENS device

Interventions

Rocabado exercises plus TENS device 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 plus TENS; Transcutaneous electrical nerve stimulation device

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• rana elattar, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master, Assistant lecturer of physical therapy.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 12, 2023
• Study Start: September 21, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 14, 2024

Record last verified: 2023-06

Locations

EG (1)