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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02716389
Other study ID # SpM2016-001
Secondary ID
Status Completed
Phase N/A
First received March 4, 2016
Last updated April 18, 2016
Start date March 2016
Est. completion date April 2016

Study information

Verified date April 2016
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The measurement of cervical spine range of motion (ROM) figures among the most common aspects of clinical diagnosis. Good reliability has been demonstrated for assessments using ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the sagittal plane), separating the respective components provides less reliable results. Current research suggest that this is due to the participants' determination of the zero position. This position is influenced by possible disposed treatments and, in particular, by the subject in case of subjective determination. The present study therefore aims to examine the test-retest reliability of separate ROM assessments using a bulls eye spirit meter.

Twenty healthy participants will be included in the trial that adopts a two-armed randomized, crossover design. With a washout-period of one week in between, each subject participates in two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension, rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all measurements, the zero position will be determined by means of a bulls eye spirit level. The difference of the two sessions consists in the design of the waiting period. In one session, the subjects will keep the mask carrying the ultrasound markers on their head. In the other session, the mask will be removed during the break.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Subscribing informed consent

- Healthy

Exclusion Criteria:

- Severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases

- Not completely healed traumata

- Drug intake in the past 48 hours

- Pregnancy

- Muscle soreness

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Zebris CMS 70

3-D Bulls Eye Spirit Meter


Locations

Country Name City State
Germany Department of Sports Medicine, Goethe University Frankfurt/Main Frankfurt am Main Hessen

Sponsors (1)

Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Cagnie B, Cools A, De Loose V, Cambier D, Danneels L. Reliability and normative database of the Zebris cervical range-of-motion system in healthy controls with preliminary validation in a group of patients with neck pain. J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):450-5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal cervical range of motion in flexion/extension 2 min. No
Secondary Maximal cervical range of motion in lateral flexion 2 min. No
Secondary Maximal cervical range of motion in rotation 2 min. No
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