CClinicalTrials.gg
Status unknownNCT05598541φ-PROMISEUpdated Oct 28, 2022

Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow

An observational study in Cultural Adaptation of Shoulder and Elbow PROMs, Definition of the Patients Acceptable Symptomatic State and Definition of the Minimal Important Difference, sponsored by Helsinki University Central Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Helsinki University Central Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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)
03

In context

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Secondary care outpatient clinic

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Recent surgery (within 2 months)
  • Insufficient compliance
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Shoulder

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

    Procedure: Surgical or non-surgical treatment

  • Elbow

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

    Procedure: Surgical or non-surgical treatment

Interventions

  • ProcedureSurgical or non-surgical treatment

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

06

What researchers measure

Primary outcomes

  1. Validation

    Assessment of inter- and intra- observer reliability of different outcome measures

    Time frame: 2 weeks

Secondary outcomes

  1. PASS

    Definition of the Patients Acceptable Symptomatic State for different outcomes

    Time frame: 1 year

  2. MID

    Definition of the Minimal Important Difference for different outcomes

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05598541
Lead sponsor
Helsinki University Central Hospital
Responsible party
Thomas Ibounig (MD, Helsinki University Central Hospital) — Principal investigator
First posted
Oct 28, 2022
Start date
Oct 26, 2022
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Oct 28, 2022

Study contacts

Thomas Ibounig, MD
Contact
thomas.ibounig@helsinki.fi
+358403567693
Saara Raatikainen
Contact
saara.raatikainen@hus.fi
+358503744600

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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