NCT05781607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

March 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

November 30, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 12, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

temporomandibular joint disordersphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Long term effective rate

    Long-term effective rate=number of effective cases/total number of cases

    12 months

Study Arms (2)

PE

Patient education combined with drug therapy group

Combination Product: Patient education combined with drug therapy

PT

Individualized comprehensive physical therapy group

Combination Product: Individualized comprehensive physical therapy

Interventions

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.

PE

Physical factor therapy and/or manual therapy

PT

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, 200011, China

RECRUITING

Related Publications (1)

  • Jin L, Yao Y, Fang Z, Fan S, Cai B, Xu L, Liu S. Long-Term Prognosis and Influencing Factors of Chinese Adolescents With Temporomandibular Disorder After Physical Therapy. J Oral Rehabil. 2024 Dec;51(12):2611-2621. doi: 10.1111/joor.13865. Epub 2024 Sep 20.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 23, 2023

Study Start

April 7, 2023

Primary Completion

April 6, 2024

Study Completion

June 6, 2024

Last Updated

November 30, 2023

Record last verified: 2023-03

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