NCT02754934

Brief Summary

This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

April 25, 2016

Last Update Submit

November 3, 2016

Conditions

Neck Pain

Keywords

chronic

Outcome Measures

Primary Outcomes (1)

  • Cervical Spine Mobility

    Patients will fill out the questionnaire once, at the beginning of the study.

    Day one of the study

Secondary Outcomes (2)

  • Pain Visual Analogue Pain Rating Scale

    Day one of the study

  • Disability on Neck Disability Index

    Day one of the study

Interventions

Cervical range of motionOTHER

Patients will fill out the Neck Disability Index, Visual Analogue Pain Rating Scale and the Self-administered Neck range of motion questionnaire.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Investigators will include 50 participants with chronic neck pain

You may qualify if:

  • Neck pain \> 90 days
  • Able to speak, read and write German

You may not qualify if:

  • Red Flags e.g. Fracture of the cervical spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Langenfeld A, Bastiaenen C, Sieben J, Swanenburg J. Development and validation of a self-administered neck mobility assessment tool (S-ROM-Neck) in chronic neck pain patients. Musculoskelet Sci Pract. 2018 Oct;37:75-79. doi: 10.1016/j.msksp.2018.04.004. Epub 2018 Apr 10.

    PMID: 29656846DERIVED

MeSH Terms

Conditions

Neck PainBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 28, 2016

Study Start

November 1, 2014

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)