Long-term Efficacy of Physical Therapy for TMDs

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05781607

Collaborator

Shanghai Jiao Tong University School of Medicine (Other)

189

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Physical therapy is one of the initial conservative treatments for TMD. Many studies and previous studies in our department have proved that it can improve the pain, mouth opening and mandibular function of patients with TMD. However, the current research on physical therapy for TMD has a short follow-up period, which cannot prove that the patients' long-term mandibular function has improved, and few studies have analyzed the relevant factors affecting the curative effect. Therefore, this study is intended to adopt a retrospective cohort study to include TMD patients who received physical therapy in our department from 2016.01-2021.12. The patients' pain, joint area noise, mandibular range of motion, mandibular function and other conditions will be followed up by remote telephone or online questionnaire, and the patients' demography, clinical symptoms, pain, oral habits, depression, anxiety, sleep status, head and neck posture and other information will be collected. The multiple regression analysis model will be used to compare and analyze the relevant factors affecting the prognosis of patients, and to intervene in advance the factors that have a significant impact on the prognosis of the disease, so as to improve the treatment effect.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders	Combination Product: Patient education combined with drug therapy Combination Product: Individualized comprehensive physical therapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

189 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Retrospective Cohort Study on the Long-term Efficacy and Influencing Factors of Physical Therapy for Temporomandibular Joint Disorders

Anticipated Study Start Date :

Apr 7, 2023

Anticipated Primary Completion Date :

Apr 6, 2024

Anticipated Study Completion Date :

Jun 6, 2024

Arms and Interventions

Arm	Intervention/Treatment
PE Patient education combined with drug therapy group	Combination Product: Patient education combined with drug therapy Receive a health education by a specialist therapist, including explaining the anatomy and function of TMJ; Explain the etiology, prognosis, treatment plan and prognosis of TMD; Correct the patients' daily oral habits, such as unilateral chewing, habitual clenching, eating too much hard food, etc; Instruct the patient to understand the rest position of the temporomandibular joint and correct the bad posture of the neck and shoulder. At the same time, corresponding medication should be given, and NSAIDS should be taken orally or externally for patients with pain.
PT Individualized comprehensive physical therapy group	Combination Product: Individualized comprehensive physical therapy Physical factor therapy and/or manual therapy

Arm

Intervention/Treatment

Patient education combined with drug therapy group

Combination Product: Patient education combined with drug therapy

Receive a health education by a specialist therapist, including explaining the anatomy and function of TMJ; Explain the etiology, prognosis, treatment plan and prognosis of TMD; Correct the patients' daily oral habits, such as unilateral chewing, habitual clenching, eating too much hard food, etc; Instruct the patient to understand the rest position of the temporomandibular joint and correct the bad posture of the neck and shoulder. At the same time, corresponding medication should be given, and NSAIDS should be taken orally or externally for patients with pain.

Individualized comprehensive physical therapy group

Combination Product: Individualized comprehensive physical therapy

Physical factor therapy and/or manual therapy

Outcome Measures

Primary Outcome Measures

Long term effective rate [12 months]
Long-term effective rate=number of effective cases/total number of cases

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The first-episode TMD patients with pain, limited mouth opening and abnormal noise in the joint area; 12-80 years old; regardless of gender; The patient received physical therapy in the outpatient department; MRI or CBCT imaging was completed before enrollment

Exclusion Criteria:

Patients with recurrent TMD; Patients who had previously undergone TMJ surgery; Patients with nervous system diseases, immune system diseases, tumors and other diseases that the attending physician considers unsuitable for inclusion in the study; Cognitive impairment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

ClinicalTrials.gov Identifier:

NCT05781607

Other Study ID Numbers:

SH9H-2022-T162-2

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

temporomandibular joint disorders

physical therapy

Additional relevant MeSH terms:

Joint Diseases

Temporomandibular Joint Disorders

Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Mar 23, 2023