Effect of Spinal Manipulation on Electromyography of the Masseter Muscle

Sponsor

University of Americas (Other)

Overall Status

Completed

CT.gov ID

NCT05138926

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bruxism Muscle Disorder	Other: Cervical Manipulation Other: Sham Cervical Manipulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 11, 2021

Actual Primary Completion Date :

Nov 11, 2021

Actual Study Completion Date :

Nov 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cervical manipulation group high speed, low amplitude cervical manipulation	Other: Cervical Manipulation high speed, low amplitude cervical manipulation
Sham Comparator: Control group placebo mobilization without manipulation	Other: Sham Cervical Manipulation Cervical mobilization without performing spinal manipulation

Arm

Intervention/Treatment

Experimental: Cervical manipulation group

high speed, low amplitude cervical manipulation

Other: Cervical Manipulation

high speed, low amplitude cervical manipulation

Sham Comparator: Control group

placebo mobilization without manipulation

Other: Sham Cervical Manipulation

Cervical mobilization without performing spinal manipulation

Outcome Measures

Primary Outcome Measures

Electromyography of the masseter muscle before intervention [baseline]
surface electromyography of the masseter muscle, measured in millivolts (mV)
Electromyography of the masseter muscle after the intervention [5 minute after intervention]
surface electromyography of the masseter muscle, measured in millivolts (mV)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de las Americas	Santiago de Chile	Santiago	Chile	7750495

Sponsors and Collaborators

University of Americas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ignacio Astudillo Ganora, Physiotherapist, Phd, University of Americas

ClinicalTrials.gov Identifier:

NCT05138926

Other Study ID Numbers:

CEC_FP_2021027

First Posted:

Dec 1, 2021

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscular Diseases

Bruxism

Study Results

No Results Posted as of Dec 1, 2021