NCT05549674

Brief Summary

The COPAIN study is comprised of three studies; a cross-sectional study (study 1), a prospective study (study 2) and a randomized controlled trial (study 3). Study 3 is described in detail in a separate protocol (the SELECT trial protocol) and is not described in further detail here.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

September 14, 2022

Last Update Submit

March 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Disability Index (SPADI) 3 months after treatment is commenced.

    SPADI is a patient-reported outcome measure designed to evaluate shoulder pain and disability. It ranges from 0 (best) to 100 (worst). It has 5 pain items and 8 disability items. The Danish version of SPADI has been found to have good reliability.

    3 months

Secondary Outcomes (3)

  • Oxford Shoulder Score

    Baseline, 3, 6 and 12 months

  • EQ-5D-3L

    Baseline, 3, 6 and 12 months

  • Active shoulder abduction range of motion (AROM)

    Baseline, 3, 6 and 12 months

Interventions

The COPAIN study is observational. There is no intervention.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with SIS referred to the place of investigation.

You may not qualify if:

  • Terminal illness or severe medical illness (ASA score higher than or equal to 4)
  • Systemic musculoskeletal disease
  • Inflammatory joint disease (e.g. rheumatoid arthritis)
  • Symptomatic cervical spine pathology
  • Thoracic outlet syndrome
  • Frozen shoulder
  • Osteoarthritis of the glenohumeral joint
  • Previous surgery, fracture or radiotherapy in the affected shoulder region
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Witten A, Clausen MB, Thorborg K, Holmich P, Barfod KW. The Challenge of Diagnosing Patients Presenting With Signs and Symptoms of Subacromial Pain Syndrome: A Descriptive Study of 741 Patients Seen in a Secondary Care Setting. Orthop J Sports Med. 2025 Apr 28;13(4):23259671251332942. doi: 10.1177/23259671251332942. eCollection 2025 Apr.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD student

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 22, 2022

Study Start

September 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations