Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders
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).
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, 이탈리아, 40138
- University of Bologna
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: splint therapy
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. |
In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
다른 이름들:
|
|
다른: physical therapy with splint therapy
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. |
In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate the effectiveness of physical therapy using the VAS scale which allows to measure the varation of pain
기간: Change from initial VAS at 3 and 6 months from the beginning of the treatment
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ROM (range of motion)
기간: The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
|
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) |
The measurement of the ROM occurs at the recruitment then at 3 and 6 months from the beginning of the treatment
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .