Effect of Cervical Manipulation on Mouth Opening

June 9, 2022 updated by: Ignacio Astudillo Ganora, University of Americas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Santiago
      • Santiago de Chile, Santiago, Chile, 7750495
        • Universidad de las Americas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

· 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical manipulation group
high-velocity, low-amplitude cervical manipulation
Other: cervical manipulation
high-velocity, low-amplitude cervical manipulation
Sham Comparator: Control group
placebo manipulation, the cervical spine will be tilted and rotated without reaching the end feel or the pump
Other: Sham intervention
lateral flexion and cervical rotation without manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
normal mouth opening in millimeters
Time Frame: Change from Baseline mouth open at 5 minutes
With a buccal goniometer, the maximum mouth opening will be measured in millimeters.
Change from Baseline mouth open at 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
masseter muscle pressure points
Time Frame: Change from Baseline pain points at 5 minutes
Pain points will be measured under pressure with a pressure pain meter or algo meter. This measurement will be measured in kilograms.
Change from Baseline pain points at 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Americas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Actual)

May 11, 2022

Study Completion (Actual)

May 11, 2022

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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