The Cranio-cervical Flexion Test Using the NOD Device

Muscle Strength Clinical Trial

— CCFT-NOD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037798
• Other study ID #: CCFT-NOD
• Status: Recruiting
• Start date: November 8, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: Zurich University of Applied Sciences
• Contact: Markus J Ernst, MSc
• Phone: +41 58934
• Email: markus.ernst[@]zhaw.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism
• Muscle Strength
• Neck Muscle Issue

Intervention

Other:
• cranio-cervical flexion test with NOD
testing the anterior neck muscles during a nodding movement and by using a dynamometer

Locations

Country	Name	City	State
Switzerland	Zurich University of applied sciences	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	baseline