NCT05138926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 16, 2021

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Electromyography of the masseter muscle before intervention

    surface electromyography of the masseter muscle, measured in millivolts (mV)

    baseline

  • Electromyography of the masseter muscle after the intervention

    surface electromyography of the masseter muscle, measured in millivolts (mV)

    5 minute after intervention

Study Arms (2)

Cervical manipulation group

EXPERIMENTAL

high speed, low amplitude cervical manipulation

Other: Cervical Manipulation

Control group

SHAM COMPARATOR

placebo mobilization without manipulation

Other: Sham Cervical Manipulation

Interventions

high speed, low amplitude cervical manipulation

Cervical manipulation group

Cervical mobilization without performing spinal manipulation

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de las Americas

Santiago, Santiago Metropolitan, 7750495, Chile

Location

MeSH Terms

Conditions

BruxismMuscular Diseases

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Phd

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 1, 2021

Study Start

August 11, 2021

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations