NCT02540343

Brief Summary

The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire into German.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 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
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

August 21, 2015

Last Update Submit

November 3, 2016

Conditions

Keywords

TranslationValidationOrebro-G

Outcome Measures

Primary Outcomes (1)

  • Pain, on the German Version of the Orebro Musculoskeletal Pain Screening Questionnaire

    Participants are asked to fill out the questionnaire twice. At the start and three to seven days after the first time.

    For every patient the average study length is one week.

Secondary Outcomes (2)

  • Disability, on the Neck Disability Index (NDI-G)

    For every patient the average study length is one week.

  • Pain, on Visual Analogue Pain Rating Scale (VAS)

    For every patient the average study length is one week.

Other Outcomes (2)

  • Voice Handicap, on the Voice Handicap Index (VHI-9)

    For every patient the average study length is one week.

  • Movement restriction, on self-reported measurements of the Range of motion of the cervical spine

    For every patient the average study length is one week.

Study Arms (3)

acute neck pain patients

Participant recently received the diagnosis of neck pain (\< 30 days) \>18 years old able to speak, read and write German, questionnaires

Other: questionnaires

chronic neck apin patients

Participant has neck pain for a longer period of time (\> 90 days) \> 18 years old able to speak, read and write German, questionnaires

Other: questionnaires

test persons

no neck pain \> 18 years old able to speak, read and write German, questionnaires

Other: questionnaires

Interventions

fill out all questionnaires twice

acute neck pain patientschronic neck apin patientstest persons

Eligibility Criteria

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

Acute and chronic neck pain patients Healthy volunteers

You may qualify if:

  • Acute:
  • Recently diagnosed with neck pain (\< 30 days)
  • Must be able to speak, read and write German
  • Chronic:
  • Neck problems for a longer period of time (\> 90 days)
  • Must be able to speak, read and write German
  • Healthy volunteers:
  • No neck pain
  • Must be able to speak, read and write German

You may not qualify if:

  • Does not speak, read and write German
  • "Red Flags" e.g. acute trauma
  • Medical knowledge

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, Brunner F, Swanenburg J. Validation of the Orebro musculoskeletal pain screening questionnaire in patients with chronic neck pain. BMC Res Notes. 2018 Mar 2;11(1):161. doi: 10.1186/s13104-018-3269-x.

MeSH Terms

Conditions

Neck Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jaap Swanenburg, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 3, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations