ClinicalTrials.gg
CompletedNCT06037798CCFT-NODUpdated Jul 24, 2024

The Cranio-cervical Flexion Test Using the NOD Device

An observational study in Muscle Strength, Neck Muscle Issue and Bruxism, sponsored by Zurich University of Applied Sciences. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Zurich University of Applied Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Muscle Strength
  • Neck Muscle Issue
  • Bruxism
  • EMG

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03

In context

Bruxism

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's enrollment of 10 is below the median of 89 across 55 observational studies indexed under Bruxism.

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Lead sponsor

Zurich University of Applied Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

adult subjects with and without bruxism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • with or without bruxism
  • German fluent
  • informend consent

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Bruxism

    subjects with known bruxism, no TMD, primary headache or neck pain

    Other: cranio-cervical flexion test with NOD

  • healthy

    non-bruxism, no primary headache, TMD or neck pain

    Other: cranio-cervical flexion test with NOD

Interventions

  • Othercranio-cervical flexion test with NOD

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

06

What researchers measure

Primary outcomes

  1. activation score = AS

    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

    Time frame: baseline

  2. performance index= PI

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

    Time frame: baseline

Secondary outcomes

  1. Neck-Pain

    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

    Time frame: baseline

07

Study locations

1 site
  • Zurich University of applied sciences
    Winterthur, 8401, Switzerland
08

References and documents

Publications

  • Ernst MJ, Sax N, Meichtry A, Aegerter AM, Luomajoki H, Ludtke K, Gallina A, Falla D; NEXpro collaboration group. Cervical musculoskeletal impairments and pressure pain sensitivity in office workers with headache. Musculoskelet Sci Pract. 2023 Aug;66:102816. doi: 10.1016/j.msksp.2023.102816. Epub 2023 Jun 26. PubMed 37394322 ↗
  • Chiu TT, Law EY, Chiu TH. Performance of the craniocervical flexion test in subjects with and without chronic neck pain. J Orthop Sports Phys Ther. 2005 Sep;35(9):567-71. doi: 10.2519/jospt.2005.35.9.567. PubMed 16268243 ↗
  • James G, Doe T. The craniocervical flexion test: intra-tester reliability in asymptomatic subjects. Physiother Res Int. 2010 Sep;15(3):144-9. doi: 10.1002/pri.456. PubMed 20146239 ↗
  • Jull G, Amiri M, Bullock-Saxton J, Darnell R, Lander C. Cervical musculoskeletal impairment in frequent intermittent headache. Part 1: Subjects with single headaches. Cephalalgia. 2007 Jul;27(7):793-802. doi: 10.1111/j.1468-2982.2007.01345.x. PubMed 17598761 ↗
  • Carrasco-Uribarren A, Marimon X, Portela A, Cabanillas-Barea S, Rodriguez-Rubio PR, Perez RA. A Novel Device for Assessment and Treatment of Upper Cervical Spine: Test-Retest Reliability Study. J Clin Med. 2023 Mar 1;12(5):1954. doi: 10.3390/jcm12051954. PubMed 36902739 ↗
  • Romeo A, Baccini M, Carreras G, Sagripanti M, Ruggeri M, Pillastrini P, Di Bari M. Reliability, Validity, and Responsiveness of the Craniocervical Flexion Test in People Who Are Asymptomatic and Patients With Nonspecific Neck Pain: A Systematic Review and Meta-Analysis. Phys Ther. 2022 Jul 4;102(7):pzac054. doi: 10.1093/ptj/pzac054. PubMed 35554598 ↗
  • Selistre LFA, Melo CS, Noronha MA. Reliability and Validity of Clinical Tests for Measuring Strength or Endurance of Cervical Muscles: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1210-1227. doi: 10.1016/j.apmr.2020.11.018. Epub 2020 Dec 28. PubMed 33383030 ↗

Individual participant data

Plan to share: No — data can be shared on demand

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Apr 2024, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2023
First posted
Sep 14, 2023
StartActual
Nov 8, 2023
Primary completionActual
Apr 30, 2024
CompletionActual
Apr 30, 2024
Last update
Jul 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06037798
Lead sponsor
Zurich University of Applied Sciences
Responsible party
Markus J. Ernst (Principal investigator, Zurich University of Applied Sciences) — Principal investigator
First posted
Sep 14, 2023
Start date
Nov 8, 2023
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Jul 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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