The Cranio-cervical Flexion Test Using the NOD Device

NCT06037798 | Completed

• 1 other identifier: CCFT-NOD
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Strength; Neck Muscle Issue; Bruxism; EMG

Outcome Measures

Primary Outcomes (2)

• 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

  baseline

• performance index= PI

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

  baseline

Secondary Outcomes (1)

• Neck-Pain

  baseline

Study Arms (2)

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

cranio-cervical flexion test with NOD OTHER

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

Bruxism; healthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult subjects with and without bruxism

You may qualify if:

• with or without bruxism
• German fluent
• informend consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead

Study Sites (1)

Zurich University of applied sciences

Winterthur, 8401, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 37394322 BACKGROUND

• 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.

  PMID: 16268243 BACKGROUND

• 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.

  PMID: 20146239 BACKGROUND

• 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.

  PMID: 17598761 BACKGROUND

• 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.

  PMID: 36902739 RESULT

• 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.

  PMID: 35554598 RESULT

• 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.

  PMID: 33383030 RESULT

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 14, 2023
• Study Start: November 8, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)