Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540343
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Swanenburg, Balgrist University Hospital

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

Condition or disease Intervention/treatment
Neck Pain Other: questionnaires

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 90 participants
Official Title: Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"-Translation and Validation of a Questionnaire
Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
fill out all questionnaires twice

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
fill out all questionnaires twice

test persons
no neck pain > 18 years old able to speak, read and write German, questionnaires
Other: questionnaires
fill out all questionnaires twice




Primary Outcome Measures :
  1. Pain, on the German Version of the Orebro Musculoskeletal Pain Screening Questionnaire [ Time Frame: For every patient the average study length is one week. ]
    Participants are asked to fill out the questionnaire twice. At the start and three to seven days after the first time.


Secondary Outcome Measures :
  1. Disability, on the Neck Disability Index (NDI-G) [ Time Frame: For every patient the average study length is one week. ]
    Participants are asked to fill out the questionnaire twice. At the start and three to seven days after the first time.

  2. Pain, on Visual Analogue Pain Rating Scale (VAS) [ Time Frame: For every patient the average study length is one week. ]
    Participants are asked to fill out the questionnaire twice. At the start and three to seven days after the first time.


Other Outcome Measures:
  1. Voice Handicap, on the Voice Handicap Index (VHI-9) [ Time Frame: For every patient the average study length is one week. ]
    Participants are asked to fill out the questionnaire twice. At the start and three to seven days after the first time.

  2. Movement restriction, on self-reported measurements of the Range of motion of the cervical spine [ Time Frame: For every patient the average study length is one week. ]
    Participants are asked to fill out the questionnaire twice. At the start and three to seven days after the first time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Acute and chronic neck pain patients Healthy volunteers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540343


Locations
Layout table for location information
Switzerland
Balgrist University Hospital
Zurich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Maastricht University
Investigators
Layout table for investigator information
Principal Investigator: Jaap Swanenburg, PhD Balgrist University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Swanenburg, PhD, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT02540343     History of Changes
Other Study ID Numbers: Balgrist 2013-0394
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Keywords provided by Swanenburg, Balgrist University Hospital:
Translation
Validation
Orebro-G
Additional relevant MeSH terms:
Layout table for MeSH terms
Musculoskeletal Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases