Effect of Cervical Manipulation on Mouth Opening

NCT ID: NCT05416788

Last Updated: 2022-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-05-11

Brief Summary

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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.

Detailed Description

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Conditions

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Bruxism Face Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cervical manipulation group

high-velocity, low-amplitude cervical manipulation

Group Type EXPERIMENTAL

cervical manipulation

Intervention Type OTHER

high-velocity, low-amplitude cervical manipulation

Control group

placebo manipulation, the cervical spine will be tilted and rotated without reaching the end feel or the pump

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type OTHER

lateral flexion and cervical rotation without manipulation

Interventions

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cervical manipulation

high-velocity, low-amplitude cervical manipulation

Intervention Type OTHER

Sham intervention

lateral flexion and cervical rotation without manipulation

Intervention Type OTHER

Eligibility Criteria

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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.

ยท 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Americas

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Astudillo Ganora

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de las Americas

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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60/2022

Identifier Type: -

Identifier Source: org_study_id

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