Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013051

Trial Description

start of 1:1-Block title

Title

Validity, reliability and age related normative values for the range of motion during the cervical flexion rotation test measured with a digital goniometer (easyangle)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The "Flexion-Rotation-Test (FRT)" is a passive test, assessing the rotation movement of the upper neck joints. It is commonly used by physiotherapists to assess patients with mechanical dysfunctions of the upper neck. These patients commonly show symptoms such as headaches, facial pain, dizziness or neck pain.

Approximately 50% of the movement is attributed to the uppermost two cervical vertebrae. For the FRT, a range of motion of 44° to each side is regarded as normal. The test is considered positive if movement is restricted by more than 10° or if the test provokes symptoms. Therefore a test limited at 34° or less to one or both directions is a positive test result. Side effects from this test occur only rarely.
It is known that neck mobility is reduced with age. Scientific knowledge currently assumes that this does not affect the upper two vertebrae. However, unpublished data suggests that the upper two vertebrae also show a reduced range of motion with age. The currently recommended cut off value of 34° does not respect age related changes of mobility. Should upper neck mobility decline with age, many older persons have false positive results, while younger persons have false negative results. Norm data for the rotation mobility of the upper neck across all age spans have not been investigated, yet. The aim of this project is therefore to collect age related norm data in a large sample.

To reach an appropriate number of participants, a multi-center design is required. Therefore a mobile and feasible measuring tool is needed. The ideal tool is a digital goniometer. The measuring protocol for this tool has not been investigated for validity and reliability, therefore validity and reliability have to be investigated prior to the norm data collection.

The following research questions will be investigated:
1. Does the digital goniometer (easyangle) measure valid data for the flexion-rotation-test?
2. Can the cervical flexion-rotation-test be measured reliably with a digital goniometer (easyangle)?
3. What is the range of upper cervical range of rotation during the FRT across the age span in healthy volunteers?

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The cervical flexion-rotation-test (FRT) is a valid and one of the most frequently used tests in headache patients. It´s aim is to assess motion dysfunction at the C1/2 segment. This segment accounts for 50% of the rotation in the cervical spine. Takasaki et al (2011) compared the FRT outcome with the MRI measurement of upper cervical segmental rotation. Their data supported the construct validity of the FRT as a clinical test of atlanto-axial rotation. The test procedure is relatively easy and well described (1-5). Hall et al showed that the diagnostic accuracy of the FRT to discriminate patients with migraine from those with cervicogenic headache is very high. Although inexperienced examiners reported greater range in rotation for the FRT than experienced examiners, their values for the diagnostic accuracy of the FRT were still within clinically acceptable levels.
All publications use the cervical range of motion (C-ROM) device for the accurate measurement of FRT range. The C-ROM is relatively expensive and handling can be difficult. The read-out at the C-ROM device depends on a compass-type display which only functions reliably in the horizontal plane. If it cannot be placed horizontally during end of range FRT, the compass needle touches the case and does not move freely. A recently developed device (easyangle, Meloq AB, 11253 Stockholm, Sweden) might be a solution for this problem, since it is relatively cheap and relies on a digital display rather than a compass. However, it’s validity and reliability has not been evaluated to date.
It is recommended that the FRT is positive if symptoms are reproduced or range of motion is limited by more than 10° compared to the anticipated normal range of 44° (SD 8°) of rotation. Because symptom reproduction is very rare, a positive FRT is mainly based on movement dysfunction. Smith et al showed that age did not significantly influence the range of rotation during the FRT. Therefore, the above recommendation applies to all patients in all age classes [1-5].
However, we are questioning this recommendation because it is in contrast to a part of the medical literature and to our clinical experience that age does indeed influence the amount of range of motion. Based on this background from the current evidence, we propose the following research questions:

Hypotheses:
1. Is the measurement with a digital goniometer (easyangle) valid for range of motion during the cervical flexion rotation test compared to an ultrasound-based movement analysis system (Zebris)?
2. Is the measurement with a digital goniometer (easyangle) reliable (inter-rater and intra-rater reliability) for the range of motion during the cervical flexion rotation test?
3. Is the range of motion of the cervical flexion rotation test, measured with a digital goniometer, age-dependent? Development of normative data for the cervical flexion–rotation test in asymptomatic adults

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013051
  •   2019/10/24
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Ethikkommission der Hochschule für angewandte Wissenschaft und Kunst HAWK Hildesheim
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   cervical flexion rotation test
  •   G43 -  Migraine
  •   G44 -  Other headache syndromes
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   healthy volunteers - aged 18-80 years - no cervical symptoms - no facial pain - no medical consultations because of headaches
  •   symptomatic patients - aged 18-80 years - diagnosed according to IHS 3beta as migraine, tension-type headache or cervicogenic headache - referral to physiotherapy - if diagnosed with migraine or tension-type headache the manual therapy assessment of the segments C0-3 has to show reduced mobility, pain or other symptoms
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

range of motion of the cervical spine during the flexion-rotation-test

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

age dependant range of motion of the cervical spine

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/12/22
  •   250
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

healthy volunteers - aged 18-80 years - no cervical symptoms - no facial pain - no medical consultations because of headaches

symptomatic patients - aged 18-80 years - diagnosed according to IHS 3beta as migraine, tension-type headache or cervicogenic headache - referral to physiotherapy - if diagnosed with migraine or tension-type headache the manual therapy assessment of the segments C0-3 has to show reduced mobility, pain or other symptoms

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

All participants: trauma to the cervical spine or the head within the past 3 month - osteoporosis - neurological disease (multiple sclerosis, stroke, ..) - cervical radiculopathy and/or neurological symptoms of the arm, neck or head - dizziness, headache or facial pain during the test movements - constant headaches within the past 48 hours prior to the test - positive safety test results prior to the test procedure (symptoms during maximum flexion ans manual rotation - positive upper cervical instability test (Sharp Purser test)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • HAWK Hildesheim
    • Mr.  MSC  Thomas  Schöttker-Königer 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universität zu Lübeck, Studiengang Physiotherapie, Haus 24a
    • Ms.  Prof. Dr  Kerstin  Lüdtke 
    • Ratzeburger Allee 160
    • 23562   Lübeck
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • HAWK Hildesheim
    • Mr.  Prof. Dr.  Axel  Schäfer 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • HAWK Hildesheim
    • Mr.  MSC  Thomas  Schoettker-Koeniger 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • HAWK Hildesheim
    • Mr.  MSC  Thomas  Schoettker-Koeniger 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2019/08/02
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.