Effect of Massage Treatment in Temporomandibular Joint | NCT04132726

Studies
Effect of Massage Treatment in Temporomandibular Joint

NCT04132726

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Oct 21, 2019Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Massage Therapy
Temporomandibular Disorder

Interventions

Massage therapy
non-effective treatment

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2018Actual

Primary Completion Date

Feb 23, 2019Actual

Completion Date

Oct 2, 2019Actual

First Submitted Date

Oct 16, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental	Experimental group which employed with massage treatment	Other: Massage therapy
Placebo	Placebo Comparator	Placebo group which employed with non-effective treatment	Other: non-effective treatment
Control	No Intervention	no treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Massage therapy	Other	Massage therapy performed by a physiotherapist	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain- Visual Analog Scale	Self-reported pain values. High scores for pain mean worse outcome for the study.	12 weeks-14 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
Patient agreement to participate in the experimental study.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merve Benli, Dr.	Istanbul University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul university,Faculty of Dentistry		Fatih		34452	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19089025	Result	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.

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics