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OpenTrials
Completed

NCT Number: NCT05416788

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.

Completed

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Key information

Conditions

Bruxism Behavior Face Pain Facial Pain Habits Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de las Americas

Santiago, Santiago Metropolitan, 7750495, Chile

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cervical Manipulation

Other

high-velocity, low-amplitude cervical manipulation

Sham intervention

Other

lateral flexion and cervical rotation without manipulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Americas

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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