Pain, JointNCT05810831
Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorders
A study testing Massage with post isometric relaxation exercises and Massage in people with Pain, Joint, run by Superior University.
Trial summary
To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Joint
- What is being tested?
- Massage with post isometric relaxation exercises and Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Aug 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria,
- absence of temporomandibular disc displacement with or without reduction,
- good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles),
- full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses
Who cannot join
- earlier splint therapy,
- pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants),
- injury of masticatory organ,
- undergoing orthodontic treatment,
- inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia
About this study
Official title: Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorder
To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility.
- Conditions
- Pain, Joint
- Being tested
- Massage with post isometric relaxation exercises, Massage
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage with post isometric relaxation exercisesDiagnostic test
Post isometric relaxation will be performed in supine position with neutrally positioned head.
MassageDiagnostic test
conservative physiotherapy protocol including massage
| Study group | Role | What they receive |
|---|---|---|
| Massage with post isometric relaxation exercises | Experimental | Not described Receives: Diagnostic Test: Massage with post isometric relaxation exercises |
| Massage | Experimental | Not described Receives: Diagnostic Test: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Massage exercises , Massage with post isometric relaxation exercises
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, JointStudies of the same condition, open and under way.
- More trials run by Superior 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810831
- Sponsor's protocol ID
- DPT/Batch-Fall18/521
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Massage Versus Massage With Post Isometric Relaxation Exercises in Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT05810831
- Acronym / sponsor ID
- DPT/Batch-Fall18/521
- Conditions
- Pain, Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 Apr 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.
To determine effectiveness of massage versus massage with post isometric relaxation exercises in temporomandibular disorders for pain and limited joint mobility.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage with post isometric relaxation exercises | Experimental | Diagnostic Test: Massage with post isometric relaxation exercises |
| Massage | Experimental | Diagnostic Test: Massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with clinical features with myofascial pain and limited mouth opening fulfilling the Axis Group I of RDC/TMD criteria,
- absence of temporomandibular disc displacement with or without reduction,
- good general health (absence of chronic diseases which may affect temporomandibular joint or the masticatory muscles),
- full dental arches with natural teeth or missing teeth replaced with fixed dental prostheses
Key exclusion criteria (5 listed)
- earlier splint therapy,
- pharmacotherapy (e.g., hormone replacement therapy, oral contraception and antidepressants),
- injury of masticatory organ,
- undergoing orthodontic treatment,
- inflammation in oral cavity (e.g., impacted molars and pulp inflammation) and fibromyalgia
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 |
|---|---|---|
| Massage with post isometric relaxation exercisesPost isometric relaxation will be performed in supine position with neutrally positioned head. | Diagnostic test | Massage with post isometric relaxation exercises |
| Massageconservative physiotherapy protocol including massage | Diagnostic test | Massage |
Primary outcome
Massage exercises , Massage with post isometric relaxation exercises
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Massage with post isometric relaxation exercises and Massage in people with Pain, Joint, run by Superior University.
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 4 inclusion and 5 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Massage exercises , Massage with post isometric relaxation exercises (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.