CCFT-NOD: The Cranio-cervical Flexion Test Using the NOD Device

Sponsor
Zurich University of Applied Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06037798
Collaborator
(none)
10
1
7
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cranio-cervical flexion test with NOD

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
The Cranio-cervical Flexion Test, Using the NOD. A Pilot and Feasibility Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. activation score = AS [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 [baseline]

    number of correctly performed 10 second holds at each incremental step. number between 1 and 10. Higher scores denote better function.

Secondary Outcome Measures

  1. Neck-Pain [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zurich University of applied sciences Winterthur Switzerland 8401

Sponsors and Collaborators

  • Zurich University of Applied Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Markus J. Ernst, Principal investigator, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT06037798
Other Study ID Numbers:
  • CCFT-NOD
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
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:

Study Results

No Results Posted as of Sep 14, 2023