Back to resultsEffect of Cervical Manipulation on Mouth Opening
Primary Purpose
Bruxism, Face Pain
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
cervical manipulation
Sham intervention
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism
Eligibility Criteria
Inclusion Criteria:
- Subjects over 18 years of age, men and women
- Students with neck and/or facial pain minimum 3/10 VAS scale
- Kinesiology students who regularly attend face-to-face classes
who have a mobility pass and a health declaration.
· Students who read and sign the informed consent.
Exclusion Criteria:
- Orthognathic surgery
- Head and neck fracture or injury
- Contraindication (red flag) to perform high-speed, low-amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)
- Positive cervical safety tests (example: Klein test positive)
Sites / Locations
- Universidad de las Americas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cervical manipulation group
Control group
Arm Description
high-velocity, low-amplitude cervical manipulation
placebo manipulation, the cervical spine will be tilted and rotated without reaching the end feel or the pump
Outcomes
Primary Outcome Measures
normal mouth opening in millimeters
With a buccal goniometer, the maximum mouth opening will be measured in millimeters.
Secondary Outcome Measures
masseter muscle pressure points
Pain points will be measured under pressure with a pressure pain meter or algo meter. This measurement will be measured in kilograms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416788
Brief Title
Effect of Cervical Manipulation on Mouth Opening
Official Title
Effect of Cervical Manipulation on Mouth Opening
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
May 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Americas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives: To compare the effects of cervical manipulation on the ranges of motion of
mouth opening and painful pressure points in the masseter and temporal muscles after
of cervical manipulation compared to the control group.
Material and methods: Single-blind randomized clinical trial with two arms, one group
intervention and a control group.
Hypothesis: There is a significant difference in mouth opening and painful pressure points
between the intervention group and the control group.
Expected results: The intervention group would significantly increase their mouth opening
maximal and decrease pressure pain in the masseter and temporalis muscles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Face Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical manipulation group
Arm Type
Experimental
Arm Description
high-velocity, low-amplitude cervical manipulation
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
placebo manipulation, the cervical spine will be tilted and rotated without reaching the end feel or the pump
Intervention Type
Other
Intervention Name(s)
cervical manipulation
Intervention Description
high-velocity, low-amplitude cervical manipulation
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
lateral flexion and cervical rotation without manipulation
Primary Outcome Measure Information:
Title
normal mouth opening in millimeters
Description
With a buccal goniometer, the maximum mouth opening will be measured in millimeters.
Time Frame
Change from Baseline mouth open at 5 minutes
Secondary Outcome Measure Information:
Title
masseter muscle pressure points
Description
Pain points will be measured under pressure with a pressure pain meter or algo meter. This measurement will be measured in kilograms.
Time Frame
Change from Baseline pain points at 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects over 18 years of age, men and women
Students with neck and/or facial pain minimum 3/10 VAS scale
Kinesiology students who regularly attend face-to-face classes
who have a mobility pass and a health declaration.
· Students who read and sign the informed consent.
Exclusion Criteria:
Orthognathic surgery
Head and neck fracture or injury
Contraindication (red flag) to perform high-speed, low-amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)
Positive cervical safety tests (example: Klein test positive)
Facility Information:
Facility Name
Universidad de las Americas
City
Santiago de Chile
State/Province
Santiago
ZIP/Postal Code
7750495
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Cervical Manipulation on Mouth Opening
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