Effects of Bowen's Therapy and Post Isometric Relaxation Techniques in Patients of Temporomandibular Joint Disorder
Primary Purpose
Temporomandibular Joint Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Bowen's therapy
Post isometric relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular disorder, Post isometric relaxation, Temporomandibular joint pain
Eligibility Criteria
Inclusion Criteria:
- Male and Female Participant aged 20-50.
- Pain on function.
- Restricted jaw movement.
- Clicking, popping sound.
- Tenderness in muscle of mastication.
- Joint tenderness.
- With a restricted mandibular range of motion 40mmor less measured interincisal.
Exclusion Criteria:
- Systematic arthropathy such as.
- Rheumatoid arthritis
- Fracture of jaw or TMJ.
- Malignant history of face and jaw.
- Prevent history of jaw or TMJ surgery.
- Subject has/ had dental/ orthodontic treatment within the past 14 days
Sites / Locations
- Lahore Dental care clinic samnabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bowen's therapy
Post isometric relaxation
Arm Description
Bowens therapy will be given to 12 patients of temporomandibular joint disorder .
post isometric relaxation technique will be given to12 patients of temporomandibular joint disorder.
Outcomes
Primary Outcome Measures
NPRS for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Maximum Mouth opening (Inter- incisal Rural) for rang of motion
Maximum mouth opening is a vital and objective clinical parameter for assessment of stomatognathic region and it represents the range of vertical mandibular range of movement.The distance between the upper central incisor and lower incisor determined by flexible intra-oral ruler ,it is valid and reliable tool for measure TMJ distance.
Jaw Functional Limitation Scale for functional activity
Jaw functional limitation is a 20 items,3 level functional scale mastication, vertical jaw mobility, emotional and verbal expression. NO LIMITATION'' score have 0 and SEVER LIMITATION '' have 10 score
Secondary Outcome Measures
Full Information
NCT ID
NCT05392049
First Posted
May 23, 2022
Last Updated
May 23, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05392049
Brief Title
Effects of Bowen's Therapy and Post Isometric Relaxation Techniques in Patients of Temporomandibular Joint Disorder
Official Title
Comparative Effects of Bowen's and Post Isometric Relaxation Techniques on Pain, Range of Motion and Function in Patients With Temporomandibular Joint Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
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
the aim of this study to compare effects of Bowen's therapy and post isometric relaxation techniques on pain, range of motions and function in patients with TMJ disorder.
Detailed Description
Temporomandibular joint disorder is a very common and serious problem of mouth and face pain related condition that mostly effect in quality of life and compromise the daily functional activities of a patient. It can be caused by any trauma, biomechanical, neuromuscular and psychologically related problems. Patient may come in acute and chronic phase. Patient condition mostly vary and worsen day by day, it thoughts that TMJD going interval throw out the life span of patient. Medicine, physical therapy interventions and surgical procedures are use in treatment of TMJ disorder. This study will conducted the comparative effects of Bowen's and post-isometric relaxation techniques on pain, ROM and functions in TMJ patients.
The study would be randomized clinical trial. Total 24 subjects will be assigned randomly into two groups by using lottery methods. Baseline treatment will be same (ultrasound, tapping) in both groups. Group A will be treated by Bowen's therapy and Group B will be treated by post-isometric relaxation technique for 30 min session (2 sessions/week and total 4 weeks). Numeric Pain Rating Scale, maximum mouth opening inter-incisal rural and jaw functional limitation scale-20 would be used as an outcome measurement tool for pain, range of motion and function respectively. Measurement will be taken at Baseline and at the end of the 4th week's treatment session. After assessing the normality data will be analyzed by using parametric / nonparametric test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Temporomandibular disorder, Post isometric relaxation, Temporomandibular joint pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bowen's therapy
Arm Type
Experimental
Arm Description
Bowens therapy will be given to 12 patients of temporomandibular joint disorder .
Arm Title
Post isometric relaxation
Arm Type
Experimental
Arm Description
post isometric relaxation technique will be given to12 patients of temporomandibular joint disorder.
Intervention Type
Other
Intervention Name(s)
Bowen's therapy
Intervention Description
Bowens technique will be apply on patients of TMJ for 2 repetitions in 1 set, 4 sets in each session for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Post isometric relaxation
Intervention Description
post isometric relaxation technique and jaw exercises (strengthen the weakened muscles, stretch the shortened muscles) with dosage 5 times/session, 5 sec rest and 2times/week for 4 weeks will apply on patients.
Primary Outcome Measure Information:
Title
NPRS for pain
Description
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
4th week
Title
Maximum Mouth opening (Inter- incisal Rural) for rang of motion
Description
Maximum mouth opening is a vital and objective clinical parameter for assessment of stomatognathic region and it represents the range of vertical mandibular range of movement.The distance between the upper central incisor and lower incisor determined by flexible intra-oral ruler ,it is valid and reliable tool for measure TMJ distance.
Time Frame
4th week
Title
Jaw Functional Limitation Scale for functional activity
Description
Jaw functional limitation is a 20 items,3 level functional scale mastication, vertical jaw mobility, emotional and verbal expression. NO LIMITATION'' score have 0 and SEVER LIMITATION '' have 10 score
Time Frame
4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and Female Participant aged 20-50.
Pain on function.
Restricted jaw movement.
Clicking, popping sound.
Tenderness in muscle of mastication.
Joint tenderness.
With a restricted mandibular range of motion 40mmor less measured interincisal.
Exclusion Criteria:
Systematic arthropathy such as.
Rheumatoid arthritis
Fracture of jaw or TMJ.
Malignant history of face and jaw.
Prevent history of jaw or TMJ surgery.
Subject has/ had dental/ orthodontic treatment within the past 14 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahore Dental care clinic samnabad
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Phone
+923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sunaina Javed, MSPT(OM)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34834522
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
Ram HK, Shah DN. Comparative evaluation of occlusal splint therapy and muscle energy technique in the management of temporomandibular disorders: A randomized controlled clinical trial. J Indian Prosthodont Soc. 2021 Oct-Dec;21(4):356-365. doi: 10.4103/jips.jips_332_21.
Results Reference
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Citation
Volkan-Yazici M, Kolsuz ME, Kafa N, Yazici G, Evli C, Orhan K. Comparison of Kinesio Taping and manual therapy in the treatment of patients with bruxism using shear-wave elastography-A randomised clinical trial. Int J Clin Pract. 2021 Dec;75(12):e14902. doi: 10.1111/ijcp.14902. Epub 2021 Oct 8.
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Results Reference
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Effects of Bowen's Therapy and Post Isometric Relaxation Techniques in Patients of Temporomandibular Joint Disorder
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