NCT01954511

Brief Summary

The objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with TMD.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 17, 2013

Last Update Submit

September 25, 2019

Conditions

Keywords

Stomatognathic diseases;Temporomandibular Joint Dysfunction Syndrome

Outcome Measures

Primary Outcomes (1)

  • Changing in maximum mouth opening pain free

    The clinical signs was based on Research Diagnostic Criteria protocol and it was measured maximum mouth opening pain free using a caliper ((Somet, 150mm, Inox, Czechoslovakia)

    Before and 5 days follow-up intervetion

Secondary Outcomes (1)

  • Changing of Pain

    Before and 5 days follow-up intervetion

Other Outcomes (1)

  • Changing in Mandibular Function Impairment Questionnaire -MFIQ

    Before and 5 days follow-up intervetion

Study Arms (1)

Manual therapy

NO INTERVENTION

Upper cervical flexion mobilization, C5 central posterior-anterior mobilization, Pressure biofeedback device

Other: Manual therapyDevice: Pressure biofeedback device

Interventions

The patient was supine with the cervical spine in a neutral position. The therapist brought about a contact of the occipital bone with the first finger and medial aspect of the hand, and other hand over the frontal region of the patient's head. The mobilizing force was delivered by flexing the upper cervical region using a combination of cephalic traction with the occipital hand and caudal pressure with the frontal hand. This technique was applied for 10 minutes

Also known as: Upper cervical flexion mobilization
Manual therapy

Device: Stabilizer - Chattanooga Group Inc., Chattanooga, Tennessee, USA The cranio-cervical flexor stabilization exercise was done 10 times holding 10 seconds the flexing position graded through feedback from a pressure biofeedback device

Also known as: Stabilizer
Manual therapy

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with myogenic or mixed temporomandibular disorders

You may not qualify if:

  • Patients diagnosed with arthrogenic or discogenic temporomandibular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction SyndromeStomatognathic Diseases

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ana Beatriz Oliveira, Phd

    Clinical professor - UFSCar

    STUDY DIRECTOR
  • Letícia Bojikian Calixtre, Pt

    UFSCar

    PRINCIPAL INVESTIGATOR
  • Francisco Alburquerque Sendín, Phd

    University of Salamanca

    PRINCIPAL INVESTIGATOR
  • Melina Nevoeiro Haik, MSc

    UFSCar

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pt

Study Record Dates

First Submitted

September 17, 2013

First Posted

October 1, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 27, 2019

Record last verified: 2019-09