Effect of Cervical Manipulation on Mouth Opening

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: Bruxism; Face Pain
• Intervention / Treatment: Other: cervical manipulation; Other: Sham intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• Sponsor: University of Americas

Study record dates

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: Stomatognathic Diseases; Tooth Diseases; Bruxism
• 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