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Completed

NCT Number: NCT05618938

Effects of Rocabado's Approach Versus Kraus Exercise Therapy

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.

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Key information

Conditions

Temporomandibular Dysfunction Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rocabado's approach

Other

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

Kraus exercises

Other

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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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