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Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
control group
test group
Sponsored by
Paolo Pillastrini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Bologna

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

splint therapy

physical therapy with splint therapy

Arm Description

Alginate 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.

The 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ROM (range of motion)
The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups. It should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite. It should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard)

Full Information

First Posted
October 24, 2018
Last Updated
May 25, 2022
Sponsor
Paolo Pillastrini
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1. Study Identification

Unique Protocol Identification Number
NCT03726060
Brief Title
Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
Official Title
Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paolo Pillastrini

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed Description
Randomized controlled clinical trial with randomization according to a multi-phase design. Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria. Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients. Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list. The 2 therapeutic protocols are: gnathological therapy (splint) associated with education and physiotherapy (test group); gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code. The code consists of a progressive number followed by the patient's initials (eg 01-F.R.). Subsequently, the patients will be randomized blinded and assigned to one of the two study groups. Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator. Both types of treatment will be performed by a single operator respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
splint therapy
Arm Type
Other
Arm Description
Alginate 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.
Arm Title
physical therapy with splint therapy
Arm Type
Other
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
splint therapy
Intervention Description
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
Intervention Type
Other
Intervention Name(s)
test group
Other Intervention Name(s)
splint therapy with physical therapy
Intervention Description
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
Description
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
Time Frame
Change from initial VAS at 3 and 6 months from the beginning of the treatment
Secondary Outcome Measure Information:
Title
ROM (range of motion)
Description
The ROM measures the joint function. It provides the analytical and millimetric measurement of functional movements with a precision gauge positioned between the incisal edges of the upper and lower anterior groups. It should be noted: maximum buccal opening; deviation of the median line; left and right lateral movements; overjet and overbite. It should also be noted the extent of final elasticity (or end-feel test and its nature (elastic, painful, hard)
Time Frame
The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32792449
Citation
Incorvati 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.
Results Reference
derived

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Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

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