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Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders

Primary Purpose

Temporomandibular Joint Dysfunction Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual therapy
Manual therapy
Pressure biofeedback device
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring Stomatognathic diseases;, Temporomandibular Joint Dysfunction Syndrome

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients diagnosed with myogenic or mixed temporomandibular disorders

Exclusion Criteria:

  • Patients diagnosed with arthrogenic or discogenic temporomandibular disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    Manual therapy

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Changing of Pain
    To evaluate pain it was applied a scale from Research Diagnostic Criteria protocol, that consists of a line scored from 0 to 10, where 0 represents no pain and 10 the worst pain that the subject has experienced, allowing it to check the number that features their pain at the moment.

    Full Information

    First Posted
    September 17, 2013
    Last Updated
    September 25, 2019
    Sponsor
    Universidade Federal de Sao Carlos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01954511
    Brief Title
    Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders
    Official Title
    Effects of Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders: Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Project was suspended for personal issues
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Sao Carlos

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Temporomandibular disorder (TMD) is a general term that refers to disorders associated with the temporomandibular joint (TMJ) and the masticatory muscles. Among the main symptoms are pre-auricular pain (in the region of the TMJ) and/or pain in the masticatory muscles. It's usual to observe that subjects with TMD also present cervical alteration. Beside this, cervical postural alterations produced by muscle tension can influence mandibular position. The intervention protocol was based on manual therapy, stabilization exercises and stretching. The technique are:. Upper cervical flexion mobilization; C5 central posterior-anterior mobilization; Stabilization exercise: Cranio-cervical flexor stabilization exercise Stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Joint Dysfunction Syndrome
    Keywords
    Stomatognathic diseases;, Temporomandibular Joint Dysfunction Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual therapy
    Arm Type
    No Intervention
    Arm Description
    Upper cervical flexion mobilization, C5 central posterior-anterior mobilization, Pressure biofeedback device
    Intervention Type
    Other
    Intervention Name(s)
    Manual therapy
    Other Intervention Name(s)
    Upper cervical flexion mobilization
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Manual therapy
    Other Intervention Name(s)
    C5 central posterior-anterior mobilization
    Intervention Description
    The patient was prone with the cervical spine in a neutral position. The therapist placed the tips of his thumbs on the posterior surface of the C5 spinous process, while the other fingers rested gently around the patients' neck. This technique was applied for 9 minutes
    Intervention Type
    Device
    Intervention Name(s)
    Pressure biofeedback device
    Other Intervention Name(s)
    Stabilizer
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Changing in maximum mouth opening pain free
    Description
    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)
    Time Frame
    Before and 5 days follow-up intervetion
    Secondary Outcome Measure Information:
    Title
    Changing of Pain
    Description
    To evaluate pain it was applied a scale from Research Diagnostic Criteria protocol, that consists of a line scored from 0 to 10, where 0 represents no pain and 10 the worst pain that the subject has experienced, allowing it to check the number that features their pain at the moment.
    Time Frame
    Before and 5 days follow-up intervetion
    Other Pre-specified Outcome Measures:
    Title
    Changing in Mandibular Function Impairment Questionnaire -MFIQ
    Description
    To evaluated mandibular function was used the Mandibular Function Impairment Questionnaire
    Time Frame
    Before and 5 days follow-up intervetion

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with myogenic or mixed temporomandibular disorders Exclusion Criteria: Patients diagnosed with arthrogenic or discogenic temporomandibular disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Beatriz Oliveira, Phd
    Organizational Affiliation
    Clinical professor - UFSCar
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Letícia Bojikian Calixtre, Pt
    Organizational Affiliation
    UFSCar
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Francisco Alburquerque Sendín, Phd
    Organizational Affiliation
    University of Salamanca
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Melina Nevoeiro Haik, MSc
    Organizational Affiliation
    UFSCar
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders

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