Effects of Rocabado's Approach Versus Kraus Exercise Therapy

April 18, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Fatima Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group: A Rocabado's approach
  1. Rest position of the tongue: The anterior 1/3 of the tongue is placed at the palate with mild pressure.
  2. Control of TMJ rotation: The jaw is repeatedly opened and closed with the anterior 1/3 of the tongue on the palate.
  3. Rhythmic stabilization technique: Gentle isometrics in the resting position are performed for jaw opening, closing, and lateral deviation.
  4. Axial extension of the neck: Combined upper cervical flexion with lower cervical extension.
Other: Rocabado's approach

Group A will be treated with Rocabado's approach. Rocabado' approach will be comprised of six exercises.

  1. Rest position of the tongue
  2. Control of TMJ rotation
  3. Rhythmic stabilization technique
  4. 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
Experimental: Group B: Kraus exercises

Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs.

  1. 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
  2. Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position
  3. 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
  4. Tongue up and wiggle: Place the tongue to the palate, then move the jaw from side to side.
  5. Strengthening: Resisted closing via self-manual resistance using tongue depressor between lower incisors: 5-10-second contractions.
Other: Kraus exercises

Group B will be treated with Kraus exercises. Kraus exercises will be comprised of eight exercise programs.

  1. Tongue position at rest
  2. Teeth apart: the patient will be educated to maintain the teeth apart can be therapeutic, which facilitates the resting tongue position
  3. Nasal-diaphragmatic breathing
  4. Tongue up and wiggle
  5. Strengthening
  6. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: 4th week

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
4th week
Temporomandibular Joint Disability Index Questionnaire:
Time Frame: 4th week

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
4th week
Fonseca's Questionnaire for severity
Time Frame: 4th week

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
4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Samrood Akram, Mphil, Riphah International University,Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2022

Primary Completion (Actual)

February 4, 2023

Study Completion (Actual)

February 4, 2023

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0151 Amna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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