Effectiveness of Physiotherapy Treatments in Temporomandibular Joint Dysfunction
The Effect of Manual Therapy and Therapeutic Exercises on Mandibular Analgesia, Muscles Relaxation, and Range of Motion in Patients With Masticatory Muscles Disorder
1 other identifier
interventional
82
1 country
1
Brief Summary
The study will determinate the influence of four selected physiotherapeutic procedures on the pain intensity, the bioelectrical activity of the masseter muscle, and the range of mandibular mobility in patients with TMDs (temporomandibular joint dysfunction).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Nov 2022
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
November 16, 2022
CompletedStudy Start
First participant enrolled
November 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedNovember 16, 2022
August 1, 2022
2 months
August 24, 2022
November 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain relief
Measurement on Visual Analogue Scale (VAS). It consists of a line, approximately 100 mm in length, at the left end of the scale "Score 0" witch means "no pain", at the right end of scale "Score 100mm" witch means "worst imaginable pain". The average value of all measurements will be analyzed.
10 days
Secondary Outcomes (2)
Electromyography surface of masseter muscle [uV- microvolts] - Rest test
10 days
Electromyography surface of masseter muscle [uV] - maximal muscle contraction (MVC)
10 days
Other Outcomes (2)
Measurement of the range of motion (ROM) [mm]
10 days
Measurement of the range of the lateral movement of the mandible [mm]
10 days
Study Arms (3)
Physiotherapeutic procedures: auto-therapy (therapeutic exercises)
ACTIVE COMPARATORSpecialized therapeutic exercises: 1. Gerry's exercise - Starting position: tongue placed on the palate. Movement: slowly opening and closing the mouth. The number of repetitions: 6 times a day for 10 movements. 2. Active lateral movements of the mandible: Starting position: separable teeth. Movement: slow movements of the lower jaw to the right and left. The number of repetitions: 6 times a day for 10 movements. 3. Protrusion and mouth opening: Starting position: teeth separated. Movement: a) lowering the jaw forward, b) opening the mouth c) closing the mouth d) retracting the lower jaw. Number of repetitions: 6 times a day for 10 movements.
Physiotherapeutic procedures: manual therapy (massage) and auto-therapy (therapeutic exercises)
ACTIVE COMPARATORManual therapy of soft tissues in the masseter muscle: 1. Extraoral massage of the masseter muscle (duration 5 minutes) 2. Intraoral massage of the masseter muscle (duration 5 minutes) 3. Functional massage of the masseter muscle (duration 5 minutes) Auto-therapy: The patient will receive instructions on how to perform therapeutic exercises at home.
Physiotherapeutic procedures: manual therapy (PIR) and auto-therapy (therapeutic exercises)
ACTIVE COMPARATORManual therapy of soft tissues in the masseter muscle: 1\. Post-isometric relaxation of the masseter muscle (duration 15 minutes). Auto-therapy: The patient will receive instructions on how to perform therapeutic exercises at home.
Interventions
Three different physiotherapy treatments will be used for, to reduce pain and tension in the masseter muscles. The assessment of pain intensity on the VAS scale will be assessed each time after the therapy. After the 5th and 10th day of therapy, it will be measured ROM and sEMG.
Eligibility Criteria
You may qualify if:
- myofacial pain
- limited mobility of TMJ
- increased muscle tension
- Female sex
You may not qualify if:
- earlier splint therapy
- pharmacotherapy
- rheumatic diseases
- metabolic diseases
- fibromyalgia
- mental diseases
- pregnancy
- orthodontic treatment
- inflammation in the oral cavity
- masticatory organ injury
- lack of stability in the masticatory organ motor system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Musculoskeletal System Rehabilitation, Pomeranian Medical University
Szczecin, Poland
Related Publications (4)
Kapos FP, Exposto FG, Oyarzo JF, Durham J. Temporomandibular disorders: a review of current concepts in aetiology, diagnosis and management. Oral Surg. 2020 Nov;13(4):321-334. doi: 10.1111/ors.12473. Epub 2020 Jan 25.
PMID: 34853604BACKGROUNDvon Piekartz H, Schwiddessen J, Reineke L, Armijo-Olivio S, Bevilaqua-Grossi D, Biasotto Gonzalez DA, Carvalho G, Chaput E, Cox E, Fernandez-de-Las-Penas C, Gadotti IC, Gil Martinez A, Gross A, Hall T, Hoffmann M, Julsvoll EH, Karegeannes M, La Touche R, Mannheimer J, Pitance L, Rocabado M, Strickland M, Stelzenmuller W, Speksnijder C, van der Meer HA, Luedke K, Ballenberger N. International consensus on the most useful assessments used by physical therapists to evaluate patients with temporomandibular disorders: A Delphi study. J Oral Rehabil. 2020 Jun;47(6):685-702. doi: 10.1111/joor.12959. Epub 2020 May 4.
PMID: 32150764BACKGROUNDDaniela Biasotto-Gonzalez, Fausto Bérzin., Electromyographic study of patients with masticatory muscles disorders, physiotherapeutic treTMJent (massage), Brazilian Journal of Oral Sciences 3(10), 2004.
BACKGROUNDRavishankar Krishna, Anoop Sharma, Shobhit Agarwal, Sweekriti Mishra, Sanober Khan, Alternative Therapies in the Treatment of Temporomandibular Disorders, Journal of Dental & Oro-facial Research Vol. 15 , 1,2018.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Double (Participant,Investigator)
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
November 16, 2022
Study Start
November 20, 2022
Primary Completion
January 30, 2023
Study Completion
March 30, 2023
Last Updated
November 16, 2022
Record last verified: 2022-08