NCT04132726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

October 16, 2019

Last Update Submit

October 18, 2019

Conditions

Keywords

Massage

Outcome Measures

Primary Outcomes (1)

  • Pain- Visual Analog Scale

    Self-reported pain values. High scores for pain mean worse outcome for the study.

    12 weeks-14 weeks

Study Arms (3)

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

Massage therapy performed by a physiotherapist

Test

non-effective treatment

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Merve Benli, Dr.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

April 17, 2018

Primary Completion

February 23, 2019

Study Completion

October 2, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations