Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

NCT ID: NCT05598541

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-26

Study Completion Date

2024-10-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Shoulder

Patients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital

Surgical or non-surgical treatment

Intervention Type PROCEDURE

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

Elbow

Patients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital

Surgical or non-surgical treatment

Intervention Type PROCEDURE

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

Interventions

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Surgical or non-surgical treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thomas Ibounig

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Thomas Ibounig, MD

Role: CONTACT

+358403567693

Saara Raatikainen

Role: CONTACT

+358503744600

Facility Contacts

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Thomas Ibounig, MD

Role: primary

+358403567693

Saara Raatikainen

Role: backup

+358503744600

Other Identifiers

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HUS/715/2021

Identifier Type: -

Identifier Source: org_study_id

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