Massage TherapyTMDNCT04132726
Effect of Massage Treatment in Temporomandibular Joint
A study testing Massage therapy and non-effective treatment in people with Massage Therapy and Temporomandibular Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among treatment options, massage therapy is one of the common therapeutic procedures and allows interesting clinical outcomes by reducing TMD… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Massage Therapy, Temporomandibular Disorder
- What is being tested?
- Massage therapy and non-effective treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2018to 2 Oct 2019
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
- Patient agreement to participate in the experimental study.
Who cannot join
- RDC/TMD II and RDC/TMDIII,
- Drug and/or removable partial or total prosthesis wearers,
- Being submitted to any type of physiotherapeutic treatment,
- Incomplete dentition,
- History of systemic diseases as diabetes or arthritis,
- The occurrence of facial trauma,
- Refusal to assume responsibility with this research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university,Faculty of Dentistry
Fatih, 34452
About this study
Official title: Effect of Massage Treatment in Patients With Temporomandibular Disorder
Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among treatment options, massage therapy is one of the common therapeutic procedures and allows interesting clinical outcomes by reducing TMD symptoms successfully. However, there has been no attempt to validate this knowledge. Thus, the aim of this study is to evaluate the effect of massage and its properties in patients with TMD.
- Conditions
- Massage Therapy, Temporomandibular Disorder
- Being tested
- Massage therapy, non-effective treatment
- Keywords
- Massage
- 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.
Massage therapyOther
Massage therapy performed by a physiotherapist
non-effective treatmentOther
non-effective treatment
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Experimental group which employed with massage treatment Receives: Other: Massage therapy |
| Placebo | Placebo comparator | Placebo group which employed with non-effective treatment Receives: Other: non-effective treatment |
| Control | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain- Visual Analog Scale
Self-reported pain values. High scores for pain mean worse outcome for the study.
Measured: 12 weeks-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start17 Apr 2018
- Primary completion23 Feb 2019
- Study completion2 Oct 2019
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 Massage TherapyStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Merve Benli, Istanbul University
- Investigators
- Merve Benli, Dr., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132726
- Sponsor's protocol ID
- 192021
- Acronym
- TMD
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005.
PubMed 19089025
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Massage Treatment in Patients With Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT04132726
- Acronym / sponsor ID
- TMD / 192021
- Conditions
- Massage Therapy, Temporomandibular Disorder
- Keywords
- Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 23 Feb 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 21 Oct 2019 (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.
Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among treatment options, massage therapy is one of the common therapeutic procedures and allows interesting clinical outcomes by reducing TMD symptoms successfully. However, there has been no attempt to validate this knowledge. Thus, the aim of this study is to evaluate the effect of massage and its properties in patients with TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Other: Massage therapyExperimental group which employed with massage treatment |
| Placebo | Placebo comparator | Other: non-effective treatmentPlacebo group which employed with non-effective treatment |
| Control | No intervention | –no treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
- Patient agreement to participate in the experimental study.
Key exclusion criteria (7 listed)
- RDC/TMD II and RDC/TMDIII,
- Drug and/or removable partial or total prosthesis wearers,
- Being submitted to any type of physiotherapeutic treatment,
- Incomplete dentition,
- History of systemic diseases as diabetes or arthritis,
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 therapyMassage therapy performed by a physiotherapist | Other | Test |
| non-effective treatmentnon-effective treatment | Other | Placebo |
Primary outcome
Pain- Visual Analog Scale
Time frame: 12 weeks-14 weeks
Self-reported pain values. High scores for pain mean worse outcome for the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Results publication: PubMed 19089025Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005.
- Individual participant dataSharing planned: Undecided
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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.
Merve Benli, Dr. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy and non-effective treatment in people with Massage Therapy and Temporomandibular Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 21 Oct 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain- Visual Analog Scale (time frame: 12 weeks-14 weeks). 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 NCT04132726, 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 21 Oct 2019.