Effect of Cervical Manipulation on Mouth Opening

• Sponsor: University of Americas (Other)
• Overall Status: Completed
• CT.gov ID: NCT05416788
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bruxism; Face Pain	Other: cervical manipulation; Other: Sham intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effect of Cervical Manipulation on Mouth Opening
• Actual Study Start Date: May 11, 2022
• Actual Primary Completion Date: May 11, 2022
• Actual Study Completion Date: May 11, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. normal mouth opening in millimeters [Change from Baseline mouth open at 5 minutes]

   With a buccal goniometer, the maximum mouth opening will be measured in millimeters.

Secondary Outcome Measures

1. masseter muscle pressure points [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

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, principal investigator, University of Americas
• ClinicalTrials.gov Identifier: NCT05416788
• Other Study ID Numbers: 60/2022
• First Posted: Jun 13, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bruxism

Study Results

No Results Posted as of Jun 13, 2022