Long-term Efficacy of Physical Therapy for TMDs

November 29, 2023 updated by: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200011
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

TMD patients who received patient education or physical therapy in the Department of Rehabilitation Medicine of the Ninth People's Hospital affiliated to Shanghai Jiaotong University Medical College from January to December 2016

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term effective rate
Time Frame: 12 months
Long-term effective rate=number of effective cases/total number of cases
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2023

Primary Completion (Estimated)

April 6, 2024

Study Completion (Estimated)

June 6, 2024

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH9H-2022-T162-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After the research results are published, the original data will be shared in the form of network data sets

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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