Cultural Adaptation of Shoulder and Elbow PROMsφ-PROMISENCT05598541
Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow
An observational study of Cultural Adaptation of Shoulder and Elbow PROMs and Definition of the Patients Acceptable Symptomatic State, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cultural Adaptation of Shoulder and Elbow PROMs, Definition of the Patients Acceptable Symptomatic State, Definition of the Minimal Important Difference
- What is being tested?
- Surgical or non-surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- 26 Oct 2022to Oct 2024
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Secondary care outpatient clinic
Who may be able to join
- Orthopedic outpatient visit at the Helsinki University Hospital
- Signed informed consent
- Age over 18 years
- Finnish as language of communication
Who cannot join
- Recent surgery (within 2 months)
- Insufficient compliance
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Thomas Ibounig, MD, +358403567693, thomas.ibounig@helsinki.fi
Saara Raatikainen, +358503744600, saara.raatikainen@hus.fi
About this study
The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.
- Conditions
- Cultural Adaptation of Shoulder and Elbow PROMs, Definition of the Patients Acceptable Symptomatic State, Definition of the Minimal Important Difference
- Being tested
- Surgical or non-surgical treatment
- Keywords
- shoulder, elbow, patient reported outcomes, validation, transcultural adaptation, patients acceptable symptomatic state (PASS), minimal important difference (MID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical or non-surgical treatmentProcedure or surgery
Surgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait)
| Study group | Role | What they receive |
|---|---|---|
| Shoulder | Patients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital Receives: Procedure: Surgical or non-surgical treatment | |
| Elbow | Patients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital Receives: Procedure: Surgical or non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation
Assessment of inter- and intra- observer reliability of different outcome measures
Measured: 2 weeks
Secondary outcomes (2)
PASS
Definition of the Patients Acceptable Symptomatic State for different outcomes
Measured: 1 year
MID
Definition of the Minimal Important Difference for different outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start26 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cultural Adaptation of Shoulder and Elbow PROMsStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Ibounig, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598541
- Sponsor's protocol ID
- HUS/715/2021
- Acronym
- φ-PROMISE
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow
- ClinicalTrials.gov ID
- NCT05598541
- Acronym / sponsor ID
- φ-PROMISE / HUS/715/2021
- Conditions
- Cultural Adaptation of Shoulder and Elbow PROMs, Definition of the Patients Acceptable Symptomatic State, Definition of the Minimal Important Difference
- Keywords
- shoulder, elbow, patient reported outcomes, validation, transcultural adaptation, patients acceptable symptomatic state (PASS), minimal important difference (MID)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 28 Oct 2022 (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.
The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder | – | Procedure: Surgical or non-surgical treatmentPatients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital |
| Elbow | – | Procedure: Surgical or non-surgical treatmentPatients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care outpatient clinic
Key inclusion criteria (4 listed)
- Orthopedic outpatient visit at the Helsinki University Hospital
- Signed informed consent
- Age over 18 years
- Finnish as language of communication
Key exclusion criteria (2 listed)
- Recent surgery (within 2 months)
- Insufficient compliance
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 |
|---|---|---|
| Surgical or non-surgical treatmentSurgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait) | Procedure or surgery | Elbow, Shoulder |
Primary outcome
Validation
Time frame: 2 weeks
Assessment of inter- and intra- observer reliability of different outcome measures
2 secondary outcomes
PASS
Time frame: 1 year
MID
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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.
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 Cultural Adaptation of Shoulder and Elbow PROMs and Definition of the Patients Acceptable Symptomatic State, run by Helsinki University Central Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Ibounig, MD (+358403567693, thomas.ibounig@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation (time frame: 2 weeks). 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 28 Oct 2022.