Vejle Hospital, University Hospital of Southern Denmark
Vejle, Region Syddanmark, 7100, Denmark
NCT Number: NCT04686435
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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Notify Me18 year–75 year
All sexes
Observational
Vejle, Region Syddanmark, 7100, Denmark
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 can consist of rotator cuff repair, Bankart repair, subacromial decompression, biceps tenodesis or tenotomy, acromioclavicular joint resection.
Time frame: 12 months
Quick-DASH (Disabilities of the Arm, Shoulder and Hand) is a patient reported questionnaire measuring upper extremity function and pain.
Time frame: 5 years
Registry obtained information about participants work affiliation from diagnosis to five years after inclusion.
Vejle Hospital
Other
Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis: The Prospective Vejle Hospital Shoulder Cohort (VHS Cohort) With Focus on Prognostic Factors
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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