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Effects of Rocabado's Approach Versus Kraus Exercise Therapy

Primary Purpose

Temporomandibular Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Rocabado's approach

Kraus exercises

About this trial

This is an interventional treatment trial for Temporomandibular Dysfunction focused on measuring Rocabado's Approach, Kraus exercises, Disability

Eligibility Criteria

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

Inclusion Criteria: Male and female between the ages of 30 to 60 years Patients with jaw pain Patients with limited jaw range of motion and associated joint pain Patients with TMJ clicking sounds Patients with pain upon muscle and joint palpation Exclusion Criteria: Diagnosis of ear, nose, and throat medical pathology underlying the tinnitus; Neurological problems that could potentially cause the tinnitus Inability to read, understand, and complete the questionnaires or understand and follow commands (e.g., illiteracy, dementia, or blindness)

Sites / Locations

Fatima Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group: A Rocabado's approach

Group B: Kraus exercises

Arm Description

Rest position of the tongue: The anterior 1/3 of the tongue is placed at the palate with mild pressure. Control of TMJ rotation: The jaw is repeatedly opened and closed with the anterior 1/3 of the tongue on the palate. Rhythmic stabilization technique: Gentle isometrics in the resting position are performed for jaw opening, closing, and lateral deviation. Axial extension of the neck: Combined upper cervical flexion with lower cervical extension.

Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs. Tongue position at rest: The patient will be instructed to maintain a resting tongue position except during function, which involves the tip of the tongue sitting on the palate with the tip resting just posterior to the upper incisors Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position Nasal-diaphragmatic breathing: The patient will be instructed in nasal breathing to facilitate function of the diaphragm, which reinforces positioning of both the tongue and teeth Tongue up and wiggle: Place the tongue to the palate, then move the jaw from side to side. Strengthening: Resisted closing via self-manual resistance using tongue depressor between lower incisors: 5-10-second contractions.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)

The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain. pre and post followup on 4th week

Temporomandibular Joint Disability Index Questionnaire:

The TMD Disability Index is a ten-question questionnaire that is based on the Oswestry Back Pain Questionnaire and the Neck Pain and Disability Questionnaire. 12 It is TMJ-specific, comprising specialized TMJ tasks (instrument playing, speech, dental care, and so on); it delivers a score ranging from 20 to 100. pre and post followup on 4th week

Fonseca's Questionnaire for severity

TMD diseases are classified using the Fonseca questionnaire into mild, moderate, severe, or no disease. It consists of ten questions about temporomandibular joint pain, head, back, and chewing discomfort, parafunctional habits, movement limits, joint clicking, perception of malocclusion, and emotional stress sensation. pre and post followup on 4th week

Secondary Outcome Measures

Full Information

NCT ID

NCT05618938

First Posted

November 8, 2022

Last Updated

April 18, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05618938

Brief Title

Effects of Rocabado's Approach Versus Kraus Exercise Therapy

Official Title

Effects of Rocabado's Approach Versus Kraus Exercise Therapy on Pain and Disability in Patients With Temporomandibular Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 4, 2022 (Actual)

Primary Completion Date

February 4, 2023 (Actual)

Study Completion Date

February 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

TMJ dysfunction is linked to trauma, joint overloading owing to para-functional behaviors, mechanical stress, and metabolic issues. Myofascial pain and dysfunction, functional derangement, and osteoarthrosis are the three most frequent TMJ-related disorders. Temporomandibular joint disorders are a type of craniofacial problems. They affect the temporomandibular joint, muscles of mastication, and other musculoskeletal tissues. The most common clinical sign and symptoms associated with TMJ dysfunction are orofacial pain and clicking. The aim of study will be to compare the effects of Rocabado's approach versus Kraus therapy on Pain and Disability in patients with temporomandibular dysfunction.

Detailed Description

A Randomized Clinical Trial will be conducted at FMH Physiotherapy Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using random sampling through opaque sealed enveloped into Group A and Group B. Group A will be treated with Rocabado's approach and Group B will be treated with Kraus exercises. Outcome measures tools will be conducted through NPRS, TMD disability index, Fonseca questionnaire after four weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Dysfunction

Keywords

Rocabado's Approach, Kraus exercises, Disability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group: A Rocabado's approach

Arm Type

Experimental

Arm Description

Arm Title

Group B: Kraus exercises

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Rocabado's approach

Intervention Description

Group A will be treated with Rocabado's approach. Rocabado' approach will be comprised of six exercises. Rest position of the tongue Control of TMJ rotation Rhythmic stabilization technique Axial extension of the neck The patients will receive Rocabado's approach consisting 6 repetitions six times a day thrice per week for four weeks

Intervention Type

Other

Intervention Name(s)

Kraus exercises

Intervention Description

Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs. Tongue position at rest Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position Nasal-diaphragmatic breathing Tongue up and wiggle Strengthening Touch and bite: Proprioceptive re-education: Lateral deviation The patients will receive Kraus exercises with the frequency of 2 sets and 10 repetitions twice a day three times per week for four weeks

Primary Outcome Measure Information:

Title

Numeric Pain Rating Scale (NPRS)

Description

Time Frame

4th week

Title

Temporomandibular Joint Disability Index Questionnaire:

Description

Time Frame

4th week

Title

Fonseca's Questionnaire for severity

Description

Time Frame

4th week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samrood Akram, Mphil

Organizational Affiliation

Riphah International University,Lahore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fatima Memorial Hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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29153236

Citation

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Effects of Rocabado's Approach Versus Kraus Exercise Therapy

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