NCT05618938

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

November 8, 2022

Last Update Submit

April 18, 2023

Conditions

Keywords

Rocabado's ApproachKraus exercisesDisability

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    4th week

Study Arms (2)

Group: A Rocabado's approach

EXPERIMENTAL

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 B: Kraus exercises

EXPERIMENTAL

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

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

Group: A Rocabado's approach

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

Group B: Kraus exercises

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 29153236BACKGROUND
  • 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.

    PMID: 29451403BACKGROUND
  • 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.

    PMID: 21884140BACKGROUND
  • 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.

    PMID: 24482784BACKGROUND
  • 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.

    PMID: 24275221BACKGROUND
  • 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.

    PMID: 29719041BACKGROUND
  • 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.

    PMID: 27556676BACKGROUND
  • 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.

    PMID: 31520181BACKGROUND
  • 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.

    PMID: 29071032BACKGROUND
  • 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.

    PMID: 29924769BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Samrood Akram, Mphil

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

November 4, 2022

Primary Completion

February 4, 2023

Study Completion

February 4, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations