Back to resultsEffect of Spinal Manipulation on Electromyography of the Masseter Muscle
Primary Purpose
Bruxism, Muscle Disorder
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Cervical Manipulation
Sham Cervical Manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism
Eligibility Criteria
Inclusion Criteria:
- Male and female physiotherapy students over 18 years of age 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.
- Recent head and neck injury or fracture (equal to or less than 3 months)
- Dental or medical diagnosis of mandibular disorder or manifest facial pain.
- Contraindication (red flag) to perform high speed and low amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)
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 speed, low amplitude cervical manipulation
placebo mobilization without manipulation
Outcomes
Primary Outcome Measures
Electromyography of the masseter muscle before intervention
surface electromyography of the masseter muscle, measured in millivolts (mV)
Electromyography of the masseter muscle after the intervention
surface electromyography of the masseter muscle, measured in millivolts (mV)
Secondary Outcome Measures
Full Information
NCT ID
NCT05138926
First Posted
November 16, 2021
Last Updated
November 30, 2021
Sponsor
University of Americas
1. Study Identification
Unique Protocol Identification Number
NCT05138926
Brief Title
Effect of Spinal Manipulation on Electromyography of the Masseter Muscle
Official Title
Immediate Effect of High Speed and Low Amplitude Cervical Manipulation on the Electromyographic Activity of the Masseter Muscle, in a Physiotherapy Students at the University of the Americas. a Clinical Trial, Single Blind
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
November 11, 2021 (Actual)
Study Completion Date
November 11, 2021 (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
Research Problem: To know the immediate effects of high speed and low amplitude cervical manipulation on the electromyographic activity of the masseter muscles of physiotherapy students at the University of the Americas Course objective: To compare the immediate effects of high-speed, low-amplitude cervical manipulation on the electromyographic activity of the masseter muscles versus a placebo intervention in kinesiology students at the University of the Americas.
Specific objectives: To describe the changes in the electromyographic activity of the masseter muscles of the high-speed cervical manipulation group in students of the physiotherapy school of the University of the Americas of the Santiago Centro campus.
To describe the changes in the electromyographic activity of the masseter muscles of the placebo group in students of the physiotherapy school of the University of the Americas of the Santiago Centro campus.
Methodology: Single-blind, randomized clinical trial. Expected results: Significant differences are expected between the intervention group and the control group. This is reflected in a decrease in electromyographic activity in the masseter muscles after high-speed cervical manipulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Muscle Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical manipulation group
Arm Type
Experimental
Arm Description
high speed, low amplitude cervical manipulation
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
placebo mobilization without manipulation
Intervention Type
Other
Intervention Name(s)
Cervical Manipulation
Intervention Description
high speed, low amplitude cervical manipulation
Intervention Type
Other
Intervention Name(s)
Sham Cervical Manipulation
Intervention Description
Cervical mobilization without performing spinal manipulation
Primary Outcome Measure Information:
Title
Electromyography of the masseter muscle before intervention
Description
surface electromyography of the masseter muscle, measured in millivolts (mV)
Time Frame
baseline
Title
Electromyography of the masseter muscle after the intervention
Description
surface electromyography of the masseter muscle, measured in millivolts (mV)
Time Frame
5 minute after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female physiotherapy students over 18 years of age 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.
Recent head and neck injury or fracture (equal to or less than 3 months)
Dental or medical diagnosis of mandibular disorder or manifest facial pain.
Contraindication (red flag) to perform high speed and low amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)
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
Learn more about this trial
Effect of Spinal Manipulation on Electromyography of the Masseter Muscle
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