Muscle StrengthCCFT-NODNCT06037798
The Cranio-cervical Flexion Test Using the NOD Device
An observational study of Muscle Strength and Neck Muscle Issue, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Strength, Neck Muscle Issue, Bruxism
- What is being tested?
- cranio-cervical flexion test with NOD
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Nov 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: adult subjects with and without bruxism
Who may be able to join
- with or without bruxism
- German fluent
- informend consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cranio-cervical Flexion Test, Using the NOD. A Pilot and Feasibility Study
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
- Being tested
- cranio-cervical flexion test with NOD
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranio-cervical flexion test with NODOther
testing the anterior neck muscles during a nodding movement and by using a dynamometer
| Study group | Role | What they receive |
|---|---|---|
| Bruxism | subjects with known bruxism, no TMD, primary headache or neck pain Receives: Other: cranio-cervical flexion test with NOD | |
| healthy | non-bruxism, no primary headache, TMD or neck pain Receives: Other: cranio-cervical flexion test with NOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start8 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus J. Ernst, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037798
- Sponsor's protocol ID
- CCFT-NOD
- Acronym
- CCFT-NOD
- Status last verified
- Jul 2024
- First submitted
- 30 Aug 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data can be shared on demand
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 37394322Chiu 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 16268243James 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 20146239Jull 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 17598761Carrasco-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 36902739Romeo 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 35554598Selistre 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cranio-cervical Flexion Test, Using the NOD. A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06037798
- Acronym / sponsor ID
- CCFT-NOD / CCFT-NOD
- Conditions
- Muscle Strength, Neck Muscle Issue, Bruxism, EMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism | – | Other: cranio-cervical flexion test with NODsubjects with known bruxism, no TMD, primary headache or neck pain |
| healthy | – | Other: cranio-cervical flexion test with NODnon-bruxism, no primary headache, TMD or neck pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult subjects with and without bruxism
Key inclusion criteria (3 listed)
- with or without bruxism
- German fluent
- informend consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cranio-cervical flexion test with NODtesting the anterior neck muscles during a nodding movement and by using a dynamometer | Other | Bruxism, healthy |
Primary outcome
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
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.
1 secondary outcome
Neck-Pain
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 37394322Ernst 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.
- Background: PubMed 16268243Chiu 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.
- Background: PubMed 20146239James 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.
- Background: PubMed 17598761Jull 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.
- Results publication: PubMed 36902739Carrasco-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.
- Results publication: PubMed 35554598Romeo 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.
- Results publication: PubMed 33383030Selistre 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.
- Individual participant dataSharing planned: No. data can be shared on demand
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Strength and Neck Muscle Issue, run by Zurich University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
activation score = AS (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06037798, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.