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OpenTrials
Completed

NCT Number: NCT06037798

The Cranio-cervical Flexion Test Using the NOD Device

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.

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Key information

Conditions

Muscle Strength Behavior Bruxism EMG Habits Neck Muscle Issue Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zurich University of applied sciences

Winterthur, 8401, Switzerland

Who can participate

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

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

Treatment and study plan

cranio-cervical flexion test with NOD

Other

testing the anterior neck muscles during a nodding movement and by using a dynamometer

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Zurich University of Applied Sciences

Other

Registry information

Official study title

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

Acronym: CCFT-NOD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Jul 24, 2024

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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