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Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05598541
Acronym
φ-PROMISE
Enrollment
600
Registered
2022-10-28
Start date
2022-10-26
Completion date
2024-10-31
Last updated
2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cultural Adaptation of Shoulder and Elbow PROMs, Definition of the Minimal Important Difference, Definition of the Patients Acceptable Symptomatic State

Keywords

shoulder, elbow, patient reported outcomes, validation, transcultural adaptation, patients acceptable symptomatic state (PASS), minimal important difference (MID)

Brief 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. 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.

Interventions

PROCEDURESurgical or non-surgical treatment

Surgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait)

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Orthopedic outpatient visit at the Helsinki University Hospital * Signed informed consent * Age over 18 years * Finnish as language of communication

Exclusion criteria

* Recent surgery (within 2 months) * Insufficient compliance

Design outcomes

Primary

MeasureTime frameDescription
Validation2 weeksAssessment of inter- and intra- observer reliability of different outcome measures

Secondary

MeasureTime frameDescription
PASS1 yearDefinition of the Patients Acceptable Symptomatic State for different outcomes
MID1 yearDefinition of the Minimal Important Difference for different outcomes

Countries

Finland

Contacts

Primary ContactThomas Ibounig, MD
thomas.ibounig@helsinki.fi+358403567693
Backup ContactSaara Raatikainen
saara.raatikainen@hus.fi+358503744600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026