Back Problems or PainREKOONCT03944018
Rehabilitation Coordinators in Orthopedic Care
A study testing Intervention with rehabilitation coordinator in people with Back Problems or Pain and Foot Problems or Pain, run by Uppsala University at 1 site in Sweden.
Trial summary
REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Back Problems or Pain, Foot Problems or Pain, Shoulder Problems or Pain
- What is being tested?
- Intervention with rehabilitation coordinator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 19 Jun 2019to 12 Jan 2022
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Not recovered in accordance with care plan or cannot be operated and wants an extension of his sick leave
Who cannot join
- Obvious medical complications for surgery (wound infection, prosthetic dislocation, stopper or the like)
- Permanent disability pension
Trial locations and contacts
1 site in 1 country.
About this study
REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic.
Read the detailed description
REKO-O is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic
- Being tested
- Intervention with rehabilitation coordinator
- Keywords
- Back pain
- Medical subject headings
- Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with rehabilitation coordinatorBehavioural
Intervention with rehabilitation coordinator in orthopedic care
| Study group | Role | What they receive |
|---|---|---|
| Intervention with rehabilitation coordinator | Experimental | Intervention with rehabilitation coordinator (RECO) Receives: Behavioral: Intervention with rehabilitation coordinator |
| Control | No intervention | TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
RTW
Number of Participants that Return to work (RTW)
Measured: 0.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start19 Jun 2019
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Problems or PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Anderzen, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944018
- Sponsor's protocol ID
- REKO-O
- Acronym
- REKOO
- Status last verified
- Oct 2020
- First submitted
- 6 May 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Coordinators in Orthopedic Care
- ClinicalTrials.gov ID
- NCT03944018
- Acronym / sponsor ID
- REKOO / REKO-O
- Keywords
- Back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 9 May 2019 (actual)
- 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.
REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic.
Detailed description
REKO-O is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with rehabilitation coordinator | Experimental | Behavioral: Intervention with rehabilitation coordinatorIntervention with rehabilitation coordinator (RECO) |
| Control | No intervention | –TAU |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Not recovered in accordance with care plan or cannot be operated and wants an extension of his sick leave
Key exclusion criteria (2 listed)
- Obvious medical complications for surgery (wound infection, prosthetic dislocation, stopper or the like)
- Permanent disability pension
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 |
|---|---|---|
| Intervention with rehabilitation coordinatorIntervention with rehabilitation coordinator in orthopedic care | Behavioural | Intervention with rehabilitation coordinator |
Primary outcome
RTW
Time frame: 0.5 year
Number of Participants that Return to work (RTW)
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 24 May 2022.
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?
A study testing Intervention with rehabilitation coordinator in people with Back Problems or Pain and Foot Problems or Pain, run by Uppsala University at 1 site in Sweden.
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 2 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 24 May 2022. 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 Sweden. 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?
RTW (time frame: 0.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.