BruxismNCT05138926
Effect of Spinal Manipulation on Electromyography of the Masseter Muscle
A study testing Cervical Manipulation in people with Bruxism and Muscle Disorder, run by University of Americas - Chili at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Muscle Disorder
- What is being tested?
- Cervical Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 11 Aug 2021to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de las Americas
Santiago, Santiago Metropolitan, 7750495
About this study
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
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.
Read more
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.
- Conditions
- Bruxism, Muscle Disorder
- Being tested
- Cervical Manipulation, Sham Cervical Manipulation
- Medical subject headings
- Bruxism, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical ManipulationOther
high speed, low amplitude cervical manipulation
Sham Cervical ManipulationOther
Cervical mobilization without performing spinal manipulation
| Study group | Role | What they receive |
|---|---|---|
| Cervical manipulation group | Experimental | high speed, low amplitude cervical manipulation Receives: Other: Cervical Manipulation |
| Control group | Sham comparator | placebo mobilization without manipulation Receives: Other: Sham Cervical Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography of the masseter muscle before intervention
surface electromyography of the masseter muscle, measured in millivolts (mV)
Measured: baseline
Electromyography of the masseter muscle after the intervention
surface electromyography of the masseter muscle, measured in millivolts (mV)
Measured: 5 minute after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start11 Aug 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Americas - Chili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Astudillo Ganora, University of Americas - Chili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138926
- Sponsor's protocol ID
- CEC_FP_2021027
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05138926
- Acronym / sponsor ID
- CEC_FP_2021027
- Conditions
- Bruxism, Muscle Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Americas - ChiliUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical manipulation group | Experimental | Other: Cervical Manipulationhigh speed, low amplitude cervical manipulation |
| Control group | Sham comparator | Other: Sham Cervical Manipulationplacebo mobilization without manipulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Orthognathic surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical Manipulationhigh speed, low amplitude cervical manipulation | Other | Cervical manipulation group |
| Sham Cervical ManipulationCervical mobilization without performing spinal manipulation | Other | Control group |
Primary outcome
Electromyography of the masseter muscle before intervention
Time frame: baseline
surface electromyography of the masseter muscle, measured in millivolts (mV)
Electromyography of the masseter muscle after the intervention
Time frame: 5 minute after intervention
surface electromyography of the masseter muscle, measured in millivolts (mV)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Manipulation in people with Bruxism and Muscle Disorder, run by University of Americas - Chili at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography of the masseter muscle before intervention (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.