Effect of Cervical Manipulation on Mouth Opening

NCT05416788 | Completed DMC

• 1 other identifier: 60/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism; Face Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• masseter muscle pressure points

  Change from Baseline pain points at 5 minutes

Study Arms (2)

Cervical manipulation group

EXPERIMENTAL

high-velocity, low-amplitude cervical manipulation

Other: cervical manipulation

Control group

SHAM COMPARATOR

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

Other: Sham intervention

Interventions

cervical manipulation OTHER

high-velocity, low-amplitude cervical manipulation

Cervical manipulation group

Sham intervention OTHER

lateral flexion and cervical rotation without manipulation

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Americas: lead

Study Sites (1)

Universidad de las Americas

Santiago, Santiago Metropolitan, 7750495, Chile

Location

MeSH Terms

Conditions

Bruxism; Facial Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 13, 2022
• Study Start: May 11, 2022
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)