Clinical trial NCT04686435: Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis
Official title: Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis: The Prospective Vejle Hospital Shoulder Cohort (VHS Cohort) With Focus on Prognostic Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Metabolic Syndrome
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: The A.P. Moller Foundation
name: The Lillebaelt Hospital Research Foundation
First posted: 2020-12-28
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will include all patients diagnosed with a shoulder disorder at their medical examination, and have given written consent to participate.

Brief summary: In a longitudinal cohort project, the objective is to evaluate general prognostic and individual risk factors for long lasting shoulder pain, with a specific focus on evaluation of the association between metabolic syndrome and tendinopathy, while simultaneous adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II).

Detailed description: The VHS Cohort is a prospective cohort trial evaluating a wide range of patient reported and clinical prognostic factors, attained prior to initiation of treatment, among shoulder patients referred for diagnostic evaluation at the specialized shoulder unit at Vejle Hospital, Denmark. The department receives approximately 2000 new patients each year.

Prior to medical examination, patients will be asked to fill in a baseline questionnaire, and from the electronic patient record, a range of different clinical factors will be obtained.

Subsequently, patients will be asked to answer questionnaires on patient reported outcomes after 1, 3, 6, and 12 months. Five years after inclusion into the trial, work affiliation will be retrieved from registries in order to evaluate association between shoulder disorders and work affiliation.

The objective of the VHS Cohort Project is to evaluate general prognostic and individual risk factors for long lasting shoulder pain. A specific focus is evaluation of the association between metabolic syndrome and rotator cuff tendinopathy while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II). In a subsequent cohort (VHS Cohort Project II), the objective will be to develop a prognostic model for the treatment effect of Rotator Cuff Related Shoulder Pain (RCRSP) (PROGRESS Theme III).

VHS Cohort Project I:

Aim 1: Evaluate the risk of consistent pain one year after diagnosis among patients diagnosed with: RCRSP; Rotator cuff lesions (conservatively treated); Acromioclavicular osteoarthritis and Adhesive capsulitis (PROGRESS Theme I).

Aim 2: Evaluate the risk of consistent pain one year after surgery for: subacromial Decompression OR Rotator Cuff lesion (PROGRESS Theme I).

Aim 3: Evaluate the risk of consistent pain one year after diagnosis in patients with metabolic syndrome compared to patients without metabolic syndrome, with particular emphasis on patients diagnosed with RCRSP while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme II).

We hypothesize that

* Significantly more patients with RCRSP have metabolic syndrome than patients diagnosed with other shoulder-specific diagnoses
* Significantly more patients with metabolic syndrome and diagnosed with RCRSP are classified as non-responders to treatment than patients with other shoulder specific diagnoses 52 weeks after initial medical examination.
* Significantly more shoulder patients with metabolic syndrome report multiple musculoskeletal pain sites than shoulder patients without metabolic syndrome at first medical examination.

Aim 4: From clinical examination findings and patient reported information identify the strongest individual predictors of prognostic value for persistent shoulder pain and disability one year after initial medical examination in patients with rotator cuff related pain syndrome (RCRSP) (Diagnostic codes: DM75.1; DM75.1A; DM75.1B; DM75.4; DM75.5; DM75.8; DM75.9) treated conservatively with either exercise, corticosteroid injection, or a combination of the two, while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme II).

Aim 5: From clinical examination findings and patient reported information identify the strongest individual preoperative predictors of prognostic value for persistent shoulder pain and disability one year after surgery for patients receiving SubAcromial Decompression (SAD) surgery (Procedure code: KNBH51), while simultaneous adjusting for other potential prognostic candidate variables (PROGRESS Theme II).

Aim 6: From clinical examination findings and patient reported information, identify the strongest individual predictors of five-year work participation rates.

Eligibility criteria: Inclusion Criteria:

* Referred for medical examination to the shoulder sector, orthopedic Department, Vejle Hospital - Hospital Lillebaelt
* Older than 18 years
* Diagnosed with shoulder disorder at medical examination.

Exclusion Criteria:

* Significant cognitive impairment or language issues
* Symptomatic cervical spine pathology
* Older than 75 years.

Primary outcomes:
measure: Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH.
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients in the normal able-bodied population changing from "Being associated with the labour market" to "Not being associated with the labour market" in work participation classification.
timeFrame: 5 years
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital, University Hospital of Southern Denmark
state: Region Of Southern Denmark
Study officials:
affiliation: Vejle Hospital, University Hospital of Southern Denmark
name: Kim G. Ingwersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: