Neck PainOrebro-GNCT02540343
Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"
An observational study of Neck Pain, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire into German. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- questionnaires
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute and chronic neck pain patients Healthy volunteers
Who may be able to join
- 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
Show all 9Show fewer
- Healthy volunteers:
- No neck pain
- Must be able to speak, read and write German
Who cannot join
- Does not speak, read and write German
- "Red Flags" e.g. acute trauma
- Medical knowledge
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"-Translation and Validation of a Questionnaire
The aim of this study is to adapt and translate the Orebro Musculoskeletal Pain Questionnaire into German.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- questionnaires
- Keywords
- Translation, Validation, Orebro-G
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
fill out all questionnaires twice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: questionnaires | |
| test persons | no neck pain > 18 years old able to speak, read and write German, questionnaires Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For every patient the average study length is one week.
Secondary outcomes (2)
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.
Measured: For every patient the average study length is one week.
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.
Measured: For every patient the average study length is one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Swanenburg, Balgrist University Hospital
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540343
- Sponsor's protocol ID
- Balgrist 2013-0394
- Acronym
- Orebro-G
- Status last verified
- Nov 2016
- First submitted
- 21 Aug 2015
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29499753
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercultural Adaptation and Validation of the "Orebro Musculoskeletal Pain Questionnaire"-Translation and Validation of a Questionnaire
- ClinicalTrials.gov ID
- NCT02540343
- Acronym / sponsor ID
- Orebro-G / Balgrist 2013-0394
- Conditions
- Neck Pain
- Keywords
- Translation, Validation, Orebro-G
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute neck pain patients | – | Other: questionnairesParticipant recently received the diagnosis of neck pain (< 30 days) >18 years old able to speak, read and write German, questionnaires |
| chronic neck apin patients | – | Other: questionnairesParticipant has neck pain for a longer period of time (> 90 days) > 18 years old able to speak, read and write German, questionnaires |
| test persons | – | Other: questionnairesno neck pain > 18 years old able to speak, read and write German, questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute and chronic neck pain patients Healthy volunteers
Key inclusion criteria (9 listed)
- Recently diagnosed with neck pain (< 30 days)
- Must be able to speak, read and write German
- Neck problems for a longer period of time (> 90 days)
- Must be able to speak, read and write German
- No neck pain
Key exclusion criteria (3 listed)
- Does not speak, read and write German
- "Red Flags" e.g. acute trauma
- Medical knowledge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesfill out all questionnaires twice | Other | acute neck pain patients, chronic neck apin patients, test persons |
Primary outcome
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.
2 secondary outcomes
Disability, on the Neck Disability Index (NDI-G)
Time frame: For every patient the average study length is one week.
Pain, on Visual Analogue Pain Rating Scale (VAS)
Time frame: For every patient the average study length is one week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Derived from this study: PubMed 29499753Langenfeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanenburg, PhD principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, on the German Version of the Orebro Musculoskeletal Pain Screening Questionnaire (time frame: For every patient the average study length is one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.