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Withdrawn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
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
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
NCT ID
NCT01954511
First Posted
September 17, 2013
Last Updated
September 25, 2019
Sponsor
Universidade Federal de Sao Carlos
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Withdrawn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
Learn more about this trial
Manual Therapy and Exercises Applied to Cervical Spine in Patients With Temporomandibular Disorders
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