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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781607
Other study ID # SH9H-2022-T162-2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 7, 2023
Est. completion date June 6, 2024

Study information

Verified date March 2023
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 189
Est. completion date June 6, 2024
Est. primary completion date April 6, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Joint Diseases
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

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
Physical factor therapy and/or manual therapy

Locations

Country Name City State
China Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Shanghai

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long term effective rate Long-term effective rate=number of effective cases/total number of cases 12 months
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