Trial document




This trial has been registered retrospectively.
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  DRKS00013051

Trial Description

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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)

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Trial Acronym

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URL of the Trial

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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 However, unpublished data suggests that the upper two vertebrae also show a reduced range of motion with age.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?

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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

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013051
  •   2019/10/24
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  •   yes
  •   Approved
  •   [---]*, Ethikkommission der Hochschule für angewandte Wissenschaft und Kunst HAWK Hildesheim
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Secondary IDs

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Health Condition or Problem studied

  •   cervical flexion rotation test
  •   G43 -  Migraine
  •   G44 -  Other headache syndromes
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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
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
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Primary Outcome

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

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Secondary Outcome

age dependant range of motion of the cervical spine

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/12/22
  •   250
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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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

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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)

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Addresses

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    • HAWK Hildesheim
    • Mr.  MSC  Thomas  Schöttker-Königer 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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    • Universität zu Lübeck, Studiengang Physiotherapie, Haus 24a
    • Ms.  Prof. Dr  Kerstin  Lüdtke 
    • Ratzeburger Allee 160
    • 23562   Lübeck
    • Germany
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    • HAWK Hildesheim
    • Mr.  Prof. Dr.  Axel  Schäfer 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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    • HAWK Hildesheim
    • Mr.  MSC  Thomas  Schoettker-Koeniger 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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Sources of Monetary or Material Support

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    • HAWK Hildesheim
    • Mr.  MSC  Thomas  Schoettker-Koeniger 
    • Goschentor 1
    • 31134  Hildesheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/08/02
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Trial Publications, Results and other Documents

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