Musculoskeletal DiseasesNCT02020772
Coordinating Teams in Primary Health Care.
A study testing coordinating primary health care and usual primary health care in people with Musculoskeletal Diseases, run by Norwegian University of Science and Technology at 4 sites in Norway.
Trial summary
Patients who suffer from musculoskeletal pain often have more than one diagnosis. These patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. Read more about this study
- Who is it for?
- Ages 21 to 58 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- coordinating primary health care and usual primary health care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 969 participants
- Where
- 4 sitesNorway
- Study dates
- Dec 2013to 1 Aug 2018
- Phase
- Interventional
- 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 21 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient in one of the participating general practices
- musculoskeletal complaints in 3 years before start of this study
- informed consent
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Stjørdal Legesenter
Stjørdal
Persaunet Legesenter
Trondheim
Rosten Legesenter
Trondheim
Sjøsiden Legesenter
Trondheim
About this study
Official title: Coordination Between General Practitioners and Physical Therapists in Primary Health Care for Musculoskeletal Pain: Effect on Sick Leave and Referral to Specialist Care.
Patients who suffer from musculoskeletal pain often have more than one diagnosis. These patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. The investigators expect that treatment and follow-up by an coordinating interdisciplinary team can improve these patients opportunity to function, increase their quality of life, and decrease their pain. The purpose of this study is to investigate if use of a coordinating interdisciplinary team in primary health care will result in reduced sick leave compared with practice as usual, and give fewer referrals to specialized health services and private rehabilitation centers. Research data will be obtained from the patients journals, questionnaires, and clinical examinations..
- Conditions
- Musculoskeletal Diseases
- Being tested
- coordinating primary health care, usual primary health care
- Keywords
- primary health care, Physical Therapy Specialty, General Practitioners, General Practice
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coordinating primary health careOther
usual primary health careOther
| Study group | Role | What they receive |
|---|---|---|
| coordinating primary health care 1 | Experimental | musculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists Receives: Other: coordinating primary health care |
| usual primary health care 1 | Active comparator | usual care of musculoskeletal pain in general practice Receives: Other: usual primary health care |
| coordinating primary health care 2 | Experimental | musculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists Receives: Other: coordinating primary health care |
| usual primary health care 2 | Active comparator | usual care of musculoskeletal pain in general practice Receives: Other: usual primary health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sick leave
average number of days sick leave during 3 years pre-intervention and during the first, second and third year of the study
Measured: 3 years
referrals to specialist care
number of referrals to specialist care including private rehabilitation centers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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 Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siv Mørkved, prof phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020772
- Sponsor's protocol ID
- 2012/1232
- Status last verified
- Oct 2021
- First submitted
- 19 Dec 2013
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garnaes KK, Morkved S, Salvesen O, Tonne T, Furan L, Gronhaug G, Vasseljen O, Johannessen HH. What factors are associated with health-related quality of life among patients with chronic musculoskeletal pain? A cross-sectional study in primary health care. BMC Musculoskelet Disord. 2021 Jan 22;22(1):102. doi: 10.1186/s12891-020-03914-x.
PubMed 33482782Garnaes KK, Morkved S, Tonne T, Furan L, Vasseljen O, Johannessen HH. Mental health among patients with chronic musculoskeletal pain and its relation to number of pain sites and pain intensity, a cross-sectional study among primary health care patients. BMC Musculoskelet Disord. 2022 Dec 22;23(1):1115. doi: 10.1186/s12891-022-06051-9.
PubMed 36544130
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordination Between General Practitioners and Physical Therapists in Primary Health Care for Musculoskeletal Pain: Effect on Sick Leave and Referral to Specialist Care.
- ClinicalTrials.gov ID
- NCT02020772
- Acronym / sponsor ID
- 2012/1232
- Conditions
- Musculoskeletal Diseases
- Keywords
- primary health care, Physical Therapy Specialty, General Practitioners, General Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 969 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 25 Dec 2013 (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.
Patients who suffer from musculoskeletal pain often have more than one diagnosis. These patients mostly have to wait a long time for the doctor's examination and treatment, and they also often have a sick leave for a long period of time. The investigators expect that treatment and follow-up by an coordinating interdisciplinary team can improve these patients opportunity to function, increase their quality of life, and decrease their pain. The purpose of this study is to investigate if use of a coordinating interdisciplinary team in primary health care will result in reduced sick leave compared with practice as usual, and give fewer referrals to specialized health services and private rehabilitation centers. Research data will be obtained from the patients journals, questionnaires, and clinical examinations..
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| coordinating primary health care 1 | Experimental | Other: coordinating primary health caremusculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists |
| usual primary health care 1 | Active comparator | Other: usual primary health careusual care of musculoskeletal pain in general practice |
| coordinating primary health care 2 | Experimental | Other: coordinating primary health caremusculoskeletal pain care by a coordinating team of one general practitioner and two physical therapists |
| usual primary health care 2 | Active comparator | Other: usual primary health careusual care of musculoskeletal pain in general practice |
Who may qualify
- Ages
- 21 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patient in one of the participating general practices
- musculoskeletal complaints in 3 years before start of this study
- informed consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| coordinating primary health care | Other | coordinating primary health care 1, coordinating primary health care 2 |
| usual primary health care | Other | usual primary health care 1, usual primary health care 2 |
Primary outcome
change in sick leave
Time frame: 3 years
average number of days sick leave during 3 years pre-intervention and during the first, second and third year of the study
referrals to specialist care
Time frame: 3 years
number of referrals to specialist care including private rehabilitation centers
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 27 Oct 2021.
- Results publication: PubMed 33482782Garnaes KK, Morkved S, Salvesen O, Tonne T, Furan L, Gronhaug G, Vasseljen O, Johannessen HH. What factors are associated with health-related quality of life among patients with chronic musculoskeletal pain? A cross-sectional study in primary health care. BMC Musculoskelet Disord. 2021 Jan 22;22(1):102. doi: 10.1186/s12891-020-03914-x.
- Derived from this study: PubMed 36544130Garnaes KK, Morkved S, Tonne T, Furan L, Vasseljen O, Johannessen HH. Mental health among patients with chronic musculoskeletal pain and its relation to number of pain sites and pain intensity, a cross-sectional study among primary health care patients. BMC Musculoskelet Disord. 2022 Dec 22;23(1):1115. doi: 10.1186/s12891-022-06051-9.
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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.
Siv Mørkved, prof phd study director
Norwegian University of Science and Technology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coordinating primary health care and usual primary health care in people with Musculoskeletal Diseases, run by Norwegian University of Science and Technology at 4 sites in Norway.
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 3 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: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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?
change in sick leave (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02020772, 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 27 Oct 2021.