Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
1 other identifier
interventional
62
1 country
1
Brief Summary
The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders. They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale). The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedStudy Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMay 31, 2022
May 1, 2022
3.3 years
October 24, 2018
May 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
The VAS measures the intensity of the pain that thethe patient perceived and it is represented by a 10 cm long scale with a score from 0 to 10. The VAS will be evaluated in 3 times: at rest; during the maximum buccal opening; during chewing
Change from initial VAS at 3 and 6 months from the beginning of the treatment
Secondary Outcomes (1)
ROM (range of motion)
The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
Study Arms (2)
splint therapy
OTHERAlginate impressions will be taken and the plaster models of the dental arches will be made. The splint will be subsequently delivered to the patient with the relative indications of use. The splint therapy consist in the use of neuromuscoral splint every the night for 6 months.
physical therapy with splint therapy
OTHERThe treatment consists of a series of interventions: advice on self-treatment techniques to be performed at home and administering manual therapy techniques addressed to: temporomandibular district, cervical and cervico-thoracic junction. Each session will be carried out individually and will last for 45 minutes. This duration will be divided as follows: 25 minutes dedicated to the temporomandibular district, 15 minutes to the cervical and cervico-thoracic junction, 5 minutes to teaching self-treatment techniques to be carried out at home and to verify the correct way of performing them. The cycle will consist of 10 sessions distributed over 3 months.
Interventions
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
Eligibility Criteria
You may qualify if:
- patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;
- patients older than 18 years;
- good knowledge of Italian language;
- patients who have signed informed consent
You may not qualify if:
- edentulism which makes it impossible to apply gnathological bite;
- patients with psychiatric problems;
- patients included in other experimental protocols;
- patients already undergoing surgical and / or radial therapy of the cervical and facial areas;
- other temporomandibular disorders without a myogenic component;
- treatment of the cervical and TMJ district in the previous 3 months;
- history of drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bologna
Bologna, Emilia-Romagna, 40138, Italy
Related Publications (2)
Romeo A, Incorvati C, Vanti C, Turolla A, Marinelli F, Defila L, Gulotta C, Marchetti C, Pillastrini P. Physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: A randomised controlled trial. J Oral Rehabil. 2024 Aug;51(8):1566-1578. doi: 10.1111/joor.13729. Epub 2024 May 17.
PMID: 38757854DERIVEDIncorvati C, Romeo A, Fabrizi A, Defila L, Vanti C, Gatto MRA, Marchetti C, Pillastrini P. Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e038438. doi: 10.1136/bmjopen-2020-038438.
PMID: 32792449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 24, 2018
First Posted
October 31, 2018
Study Start
October 31, 2018
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share