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Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire" (Orebro-G)

Primary Purpose

Neck Pain

Status

Completed

Phase

Locations

Switzerland

Study Type

Observational

Intervention

questionnaires

About this trial

This is an observational trial for Neck Pain focused on measuring Translation, Validation, Orebro-G

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

acute neck pain patients

chronic neck apin patients

test persons

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Pain, on Visual Analogue Pain Rating Scale (VAS)

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

Full Information

NCT ID

NCT02540343

First Posted

August 21, 2015

Last Updated

November 3, 2016

Sponsor

Balgrist University Hospital

Collaborators

Maastricht University

1. Study Identification

Unique Protocol Identification Number

NCT02540343

Brief Title

Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"

Acronym

Orebro-G

Official Title

Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"-Translation and Validation of a Questionnaire

Study Type

Observational

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Balgrist University Hospital

Collaborators

Maastricht University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Participants will fill out all questionnaires at baseline and again after three days. If the questionnaires have not been returned by day four the participant receives a reminder telephone call. Patients that do not return the questionnaires by day seven are dismissed. The baseline measurement is done at the practice the second measurement will be done by the patient at home. To send the questionnaire back the participant receives a prepaid envelope.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

Keywords

Translation, Validation, Orebro-G

7. Study Design

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acute neck pain patients

Arm Description

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

Arm Title

chronic neck apin patients

Arm Description

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

Arm Title

test persons

Arm Description

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

Intervention Type

Other

Intervention Name(s)

questionnaires

Intervention Description

fill out all questionnaires twice

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

For every patient the average study length is one week.

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

For every patient the average study length is one week.

Title

Pain, on Visual Analogue Pain Rating Scale (VAS)

Description

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

Time Frame

For every patient the average study length is one week.

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

For every patient the average study length is one week.

Title

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

Description

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

Time Frame

For every patient the average study length is one week.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Does not speak, read and write German "Red Flags" e.g. acute trauma Medical knowledge

Study Population Description

Acute and chronic neck pain patients Healthy volunteers

Sampling Method

Non-Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaap Swanenburg, PhD

Organizational Affiliation

Balgrist University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Balgrist University Hospital

City

Zurich

ZIP/Postal Code

8008

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

29499753

Citation

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.

Results Reference

derived

Learn more about this trial

Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"

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