The Cranio-cervical Flexion Test Using the NOD Device (CCFT-NOD)

November 9, 2023 updated by: Markus J. Ernst, Zurich University of Applied Sciences

The Cranio-cervical Flexion Test, Using the NOD. A Pilot and Feasibility Study

to measure strength of the deep anterior neck muscles with a new measurement protocol and by using the NOD device, a dynamometer, in subjects with and without bruxism, and compared to EMG on the superficial muscles of the anterior neck and the masseter muscle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

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

Study Contact

Study Locations

  • Switzerland
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Zurich University of Applied Sciences
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

adult subjects with and without bruxism

Description

Inclusion Criteria:

  • with or without bruxism
  • German fluent
  • informend consent

Exclusion Criteria:

  • primary headache
  • cranio-mandibulary disorders (CMD) in >3 months within the last 12 months
  • current neck pain intensity > 2 out of 10 on Numeric rating scale
  • known:
  • neurological pathologies
  • mental impairments or diseases
  • pregnancy
  • rheumatic disorders

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bruxism
subjects with known bruxism, no TMD, primary headache or neck pain
Other: cranio-cervical flexion test with NOD
testing the anterior neck muscles during a nodding movement and by using a dynamometer
healthy
non-bruxism, no primary headache, TMD or neck pain
Other: cranio-cervical flexion test with NOD
testing the anterior neck muscles during a nodding movement and by using a dynamometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activation score = AS
Time Frame: baseline
stepwise (5 steps) and correct (no substitution by the superficial muscles) activation of the deep neck flexors, that can be hold for 10 seconds: Each step increases by 3.4N. The scale will be offset, starting at 0N. Steps are accordingly: 3.4N, 6.8N, 10.2N, 13.6N, 17N. Higher scores denote better function
baseline
performance index= PI
Time Frame: baseline
number of correctly performed 10 second holds at each incremental step. number between 1 and 10. Higher scores denote better function.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck-Pain
Time Frame: baseline
neck pain, headache or discomfort during or immediate after the test protocol, measured by a numeric rating scale from 0 to 10. Higher scores denote more pain or discomfort
baseline

Collaborators and Investigators

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

Sponsor

Zurich University of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 8, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCFT-NOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data can be shared on demand

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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