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Completed

NCT Number: NCT04686435

Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vejle Hospital, University Hospital of Southern Denmark

Vejle, Region Syddanmark, 7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture

Other

Treatment consisting of different non-surgical interventions as recommended by the orthopedic specialist and decided upon in shared decision making with the patient

Other names: Physiotherapy, Exercise, Corticosteroid injection, Medication, Acupuncture

Surgery

Procedure

Surgery can consist of rotator cuff repair, Bankart repair, subacromial decompression, biceps tenodesis or tenotomy, acromioclavicular joint resection.

Primary outcomes

  1. Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH.

    Time frame: 12 months

    Quick-DASH (Disabilities of the Arm, Shoulder and Hand) is a patient reported questionnaire measuring upper extremity function and pain.

Secondary outcomes

  1. 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.

    Time frame: 5 years

    Registry obtained information about participants work affiliation from diagnosis to five years after inclusion.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Region of Southern Denmark
  • The A.P. Moller Foundation
  • The Lillebaelt Hospital Research Foundation

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2020
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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