Back to resultsComparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction
Primary Purpose
Temporo-mandibular Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Rocabdo exercises
Postural correction exercises
Sponsored by
About this trial
This is an interventional treatment trial for Temporo-mandibular Dysfunction
Eligibility Criteria
Inclusion Criteria: Male and female of 18 to 45 years with TMD pain for less than six months and pain rating at least moderate in severity Must not be receiving any treatment for TMD at the onset of the study (for example, an occlusal splint, prescription medication) Pain must have been of masticatory muscle origin Pain on jaw movement, headache and referred pain are suggestive of a muscular problems. Exclusion Criteria: Patients of Systemic rheumatic disease & Fibromyalgia Dental pathology Orofacial pain disorders Cervical structural pathology Current use of analgesics more than 3 days per week Current use of narcotics, hypnotic drugs, sedatives, or muscle relaxants
Sites / Locations
- Foundation University IslamabadRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A (Rocabdo exercises)
Group B (Postural correction exercises)
Arm Description
The exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day. It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction.
This group will perform posture correction exercises for six days and six times per day. Posture correction exercises include chest stretch , wall stretch , chin tuck in and face down arm lifts.
Outcomes
Primary Outcome Measures
Mouth opening
Maximum pain free opening from incisor to incisor measured vertically by ruler method where the score of less than 25mm indicate TMJ dysfunction
Kinesiophobia
Kinesiophobia is excessive fear of physical movement that results from a feeling of vulnerability to painful injury Or re-injury where the score of 37 on Tampa scale indicate there is kinesiophobia
Secondary Outcome Measures
Full Information
NCT ID
NCT05917769
First Posted
June 15, 2023
Last Updated
June 15, 2023
Sponsor
Foundation University Islamabad
1. Study Identification
Unique Protocol Identification Number
NCT05917769
Brief Title
Comparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction
Official Title
Comparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Temporo-mandibular dysfunction can cause pain and tenderness of jaw so posture correction exercises and Rocabado exercises will be performed targeting jaw opening and kinesiophobia.
Detailed Description
Temporo-mandibular dysfunction refers to pain in area of Temporo-mandibular joint and masticatory muscles.Temporo-mandibular dysfunction can cause pain or tenderness of jaw and aching pain in and around the ear along with difficulty in chewing.In addition to these symptoms the Temporo-mandibular dysfunction results in impairment of mouth opening. So the posture correction exercises and Rocabado exercises will be used to treat patients which will target jaw opening and kinesiophobia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporo-mandibular Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A will receive conventional therapy for pain management and Rocabado exercises.
Group B will receive similar basic conventional therapy for pain management and perform posture correction exercises.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (Rocabdo exercises)
Arm Type
Experimental
Arm Description
The exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day. It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction.
Arm Title
Group B (Postural correction exercises)
Arm Type
Experimental
Arm Description
This group will perform posture correction exercises for six days and six times per day. Posture correction exercises include chest stretch , wall stretch , chin tuck in and face down arm lifts.
Intervention Type
Other
Intervention Name(s)
Rocabdo exercises
Intervention Description
The exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day.
It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction. This group will only perform Rocabdo exercises.
Intervention Type
Other
Intervention Name(s)
Postural correction exercises
Intervention Description
Posture correction exercises will be performed six times a day for six days.
Patient will be assessed on the first day and then on the last day of the treatment, i.e., on 6th day the patient will be re-assessed after they have performed posture correction exercises.
Posture correction exercises consist of chin tuck in, chest stretch, wall stretch, on your Back chest stretch and face down arm lifts.
Primary Outcome Measure Information:
Title
Mouth opening
Description
Maximum pain free opening from incisor to incisor measured vertically by ruler method where the score of less than 25mm indicate TMJ dysfunction
Time Frame
6 days
Title
Kinesiophobia
Description
Kinesiophobia is excessive fear of physical movement that results from a feeling of vulnerability to painful injury Or re-injury where the score of 37 on Tampa scale indicate there is kinesiophobia
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female of 18 to 45 years with TMD pain for less than six months and pain rating at least moderate in severity
Must not be receiving any treatment for TMD at the onset of the study (for example, an occlusal splint, prescription medication)
Pain must have been of masticatory muscle origin
Pain on jaw movement, headache and referred pain are suggestive of a muscular problems.
Exclusion Criteria:
Patients of Systemic rheumatic disease & Fibromyalgia
Dental pathology
Orofacial pain disorders
Cervical structural pathology
Current use of analgesics more than 3 days per week
Current use of narcotics, hypnotic drugs, sedatives, or muscle relaxants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rida Nasir, MSMSKPT
Phone
03215205662
Email
nasirrida487@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Furqan Hassan, PHD
Phone
03334056768
Facility Information:
Facility Name
Foundation University Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
64000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rida Nasir
Phone
03215205662
12. IPD Sharing Statement
Learn more about this trial
Comparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction
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