CClinicalTrials.gg
CompletedNCT05618938Updated Apr 19, 2023

Effects of Rocabado's Approach Versus Kraus Exercise Therapy

An interventional study of Rocabado's approach and Kraus exercises in Temporomandibular Dysfunction, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temporomandibular Dysfunction

Keywords

  • Rocabado's Approach
  • Kraus exercises
  • Disability
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherRocabado'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

  • OtherKraus 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4th week

  2. 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

    Time frame: 4th week

  3. 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

    Time frame: 4th week

07

Study locations

1 site
  • Fatima Memorial Hospital
    Lahore, Punjab 54000, Pakistan
08

References and documents

Publications

  • Scrivani SJ, Khawaja SN, Bavia PF. Nonsurgical Management of Pediatric Temporomandibular Joint Dysfunction. Oral Maxillofac Surg Clin North Am. 2018 Feb;30(1):35-45. doi: 10.1016/j.coms.2017.08.001. PubMed 29153236 ↗
  • Matsubara R, Yanagi Y, Oki K, Hisatomi M, Santos KC, Bamgbose BO, Fujita M, Okada S, Minagi S, Asaumi J. Assessment of MRI findings and clinical symptoms in patients with temporomandibular joint disorders. Dentomaxillofac Radiol. 2018 May;47(4):20170412. doi: 10.1259/dmfr.20170412. Epub 2018 Feb 22. PubMed 29451403 ↗
  • Dimitroulis G. Temporomandibular joint surgery: what does it mean to the dental practitioner? Aust Dent J. 2011 Sep;56(3):257-64. doi: 10.1111/j.1834-7819.2011.01351.x. PubMed 21884140 ↗
  • Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. PubMed 24482784 ↗
  • Slade GD, Bair E, Greenspan JD, Dubner R, Fillingim RB, Diatchenko L, Maixner W, Knott C, Ohrbach R. Signs and symptoms of first-onset TMD and sociodemographic predictors of its development: the OPPERA prospective cohort study. J Pain. 2013 Dec;14(12 Suppl):T20-32.e1-3. doi: 10.1016/j.jpain.2013.07.014. PubMed 24275221 ↗
  • Yadav S, Yang Y, Dutra EH, Robinson JL, Wadhwa S. Temporomandibular Joint Disorders in Older Adults. J Am Geriatr Soc. 2018 Jul;66(6):1213-1217. doi: 10.1111/jgs.15354. Epub 2018 May 2. PubMed 29719041 ↗
  • Lora VR, Canales Gde L, Goncalves LM, Meloto CB, Barbosa CM. Prevalence of temporomandibular disorders in postmenopausal women and relationship with pain and HRT. Braz Oral Res. 2016 Aug 22;30(1):e100. doi: 10.1590/1807-3107BOR-2016.vol30.0100. PubMed 27556676 ↗
  • Ernst M, Schenkenberger AE, Domin M, Kordass B, Lotze M. Effects of centric mandibular splint therapy on orofacial pain and cerebral activation patterns. Clin Oral Investig. 2020 Jun;24(6):2005-2013. doi: 10.1007/s00784-019-03064-y. Epub 2019 Sep 13. PubMed 31520181 ↗
  • Seifi M, Ebadifar A, Kabiri S, Badiee MR, Abdolazimi Z, Amdjadi P. Comparative effectiveness of Low Level Laser therapy and Transcutaneous Electric Nerve Stimulation on Temporomandibular Joint Disorders. J Lasers Med Sci. 2017 Summer;8(Suppl 1):S27-S31. doi: 10.15171/jlms.2017.s6. Epub 2017 Aug 29. PubMed 29071032 ↗
  • Lopez-Martos R, Gonzalez-Perez LM, Ruiz-Canela-Mendez P, Urresti-Lopez FJ, Gutierrez-Perez JL, Infante-Cossio P. Randomized, double-blind study comparing percutaneous electrolysis and dry needling for the management of temporomandibular myofascial pain. Med Oral Patol Oral Cir Bucal. 2018 Jul 1;23(4):e454-e462. doi: 10.4317/medoral.22488. PubMed 29924769 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05618938
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 16, 2022
Start date
Nov 4, 2022
Primary completion
Feb 4, 2023
Completion
Feb 4, 2023
Last update
Apr 19, 2023

Study contacts

Samrood Akram, Mphil
principal investigator · Riphah International University,Lahore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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