Temporomandibular Joint DisordersNCT05781607
Long-term Efficacy of Physical Therapy for TMDs
An observational study of Temporomandibular Joint Disorders, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Patient education combined with drug therapy and Individualized comprehensive physical therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2023to 6 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200011
Shasha Liu, 008613795493660, shuiliushasha@foxmail.com
About this study
Official title: 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Patient education combined with drug therapy, Individualized comprehensive physical therapy
- Keywords
- temporomandibular joint disorders, physical therapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education combined with drug therapyCombination product
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 therapyCombination product
Physical factor therapy and/or manual therapy
| Study group | Role | What they receive |
|---|---|---|
| PE | Patient education combined with drug therapy group Receives: Combination Product: Patient education combined with drug therapy | |
| PT | Individualized comprehensive physical therapy group Receives: Combination Product: Individualized comprehensive physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effective rate
Long-term effective rate=number of effective cases/total number of cases
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start7 Apr 2023
- Primary completion6 Apr 2024 (estimated)
- Study completion6 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781607
- Sponsor's protocol ID
- SH9H-2022-T162-2
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the research results are published, the original data will be shared in the form of network data sets
Publications
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.
PubMed 39305035
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study on the Long-term Efficacy and Influencing Factors of Physical Therapy for Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT05781607
- Acronym / sponsor ID
- SH9H-2022-T162-2
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- temporomandibular joint disorders, physical therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 6 Apr 2024 (estimated)
- Study completion
- 6 Jun 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE | – | Combination Product: Patient education combined with drug therapyPatient education combined with drug therapy group |
| PT | – | Combination Product: Individualized comprehensive physical therapyIndividualized comprehensive physical therapy group |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education combined with drug therapyReceive 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. | Combination product | PE |
| Individualized comprehensive physical therapyPhysical factor therapy and/or manual therapy | Combination product | PT |
Primary outcome
Long term effective rate
Time frame: 12 months
Long-term effective rate=number of effective cases/total number of cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 39305035Jin 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.
- Individual participant dataSharing planned: Undecided. After the research results are published, the original data will be shared in the form of network data sets
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effective rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.