Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

Recruiting

• Conditions: Definition of the Minimal Important Difference; Definition of the Patients Acceptable Symptomatic State; Cultural Adaptation of Shoulder and Elbow PROMs
• Interventions: Procedure: Surgical or non-surgical treatment

• Registration Number: NCT05598541
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-26
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shoulder	Surgical or non-surgical treatment	Patients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital
Elbow	Surgical or non-surgical treatment	Patients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital

Primary Outcome Measures

Name	Time	Method
Validation	2 weeks	Assessment of inter- and intra- observer reliability of different outcome measures

Secondary Outcome Measures

Name	Time	Method
MID	1 year	Definition of the Minimal Important Difference for different outcomes
PASS	1 year	Definition of the Patients Acceptable Symptomatic State for different outcomes

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland