Shoulder PainNCT01300091
Burden and Outcome of Shoulder Disorders in Primary Health Care
An observational study of Shoulder Pain and Shoulder Mobility Impairment, run by Central Finland Hospital District at 1 site in Finland.
Trial summary
Consumption of medical care and outcome of shoulder pain and disability in primary care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Pain, Shoulder Mobility Impairment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients consulting a general practitioner due to shoulder disorder during the recruitment period are included. The study population consists of two public health centres with a population of 120 000 individuals and two occupational medicine clinics with a population of 15 000 individuals. The population of health centres and occupational health clinics overlap partially.
Who may be able to join
- All individuals suffering from shoulder pain or impairment
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Consumption of medical care and outcome of shoulder pain and disability in primary care.
Read the detailed description
Shoulder pain and impairment are common in primary health care. The prognosis of several individuals consulting for a new episode of shoulder problem is surprisingly poor. The objectives are to characterize the consumption of medical care and outcome of shoulder pain and disability in primary health care.
A composite questionnaire consisting of demographic information and ASES questionnaire was used to measure the shoulder function. The patients were sent a second questionnaire after one year.
- Conditions
- Shoulder Pain, Shoulder Mobility Impairment
- Keywords
- Shoulder, Pain, Range of Motion, Disability Evaluation, Function, Sick Leave, Primary Health Care, Visual Analog Scale, Visual Analog Pain Scale, The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form
- Medical subject headings
- Shoulder Pain, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of medical care
Number of consultations, referrals, and radiologic examinations; Use of pain medication; Number of days on sick leave; Number of visits to physiotherapist; Number of surgical procedures
Measured: one year
Secondary outcomes (1)
Development of the ASES score
ASES score: the patient self-report section of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
Why it stopped: Recruitment not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300091
- Sponsor's protocol ID
- B07103-3
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2011
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dorrestijn O, Greving K, van der Veen WJ, van der Meer K, Diercks RL, Winters JC, Stevens M. Patients with shoulder complaints in general practice: consumption of medical care. Rheumatology (Oxford). 2011 Feb;50(2):389-95. doi: 10.1093/rheumatology/keq333. Epub 2010 Nov 2.
PubMed 21047806Reilingh ML, Kuijpers T, Tanja-Harfterkamp AM, van der Windt DA. Course and prognosis of shoulder symptoms in general practice. Rheumatology (Oxford). 2008 May;47(5):724-30. doi: 10.1093/rheumatology/ken044. Epub 2008 Apr 14.
PubMed 18411219
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden and Outcome of Shoulder Disorders in Primary Health Care
- ClinicalTrials.gov ID
- NCT01300091
- Acronym / sponsor ID
- B07103-3
- Conditions
- Shoulder Pain, Shoulder Mobility Impairment
- Keywords
- Shoulder, Pain, Range of Motion, Disability Evaluation, Function, Sick Leave, Primary Health Care, Visual Analog Scale
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- First posted
- 21 Feb 2011 (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.
Consumption of medical care and outcome of shoulder pain and disability in primary care.
Detailed description
Shoulder pain and impairment are common in primary health care. The prognosis of several individuals consulting for a new episode of shoulder problem is surprisingly poor. The objectives are to characterize the consumption of medical care and outcome of shoulder pain and disability in primary health care.
A composite questionnaire consisting of demographic information and ASES questionnaire was used to measure the shoulder function. The patients were sent a second questionnaire after one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients consulting a general practitioner due to shoulder disorder during the recruitment period are included. The study population consists of two public health centres with a population of 120 000 individuals and two occupational medicine clinics with a population of 15 000 individuals. The population of health centres and occupational health clinics overlap partially.
Key inclusion criteria (1 listed)
- All individuals suffering from shoulder pain or impairment
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consumption of medical care
Time frame: one year
Number of consultations, referrals, and radiologic examinations; Use of pain medication; Number of days on sick leave; Number of visits to physiotherapist; Number of surgical procedures
1 secondary outcome
Development of the ASES score
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 21047806Dorrestijn O, Greving K, van der Veen WJ, van der Meer K, Diercks RL, Winters JC, Stevens M. Patients with shoulder complaints in general practice: consumption of medical care. Rheumatology (Oxford). 2011 Feb;50(2):389-95. doi: 10.1093/rheumatology/keq333. Epub 2010 Nov 2.
- Background: PubMed 18411219Reilingh ML, Kuijpers T, Tanja-Harfterkamp AM, van der Windt DA. Course and prognosis of shoulder symptoms in general practice. Rheumatology (Oxford). 2008 May;47(5):724-30. doi: 10.1093/rheumatology/ken044. Epub 2008 Apr 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shoulder Pain and Shoulder Mobility Impairment, run by Central Finland Hospital District at 1 site in Finland.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Mar 2023. 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 Finland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Consumption of medical care (time frame: one year). 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 NCT01300091, which also lists 2 linked publications.
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 6 Mar 2023.