Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04686435
• Other study ID #: VHS Cohort 20/12316
• Status: Active, not recruiting
• Start date: January 4, 2021
• Est. completion date: January 4, 2028

Study information

• Verified date: February 2024
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: January 4, 2028
• Est. primary completion date: January 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Shoulder Pain
• Syndrome

Intervention

Other:
• Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture
Treatment consisting of different non-surgical interventions as recommended by the orthopedic specialist and decided upon in shared decision making with the patient

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

Locations

Country	Name	City	State
Denmark	Vejle Hospital, University Hospital of Southern Denmark	Vejle	Region Of Southern Denmark

Sponsors (4)

Lead Sponsor	Collaborator
Vejle Hospital	Region of Southern Denmark, The A.P. Moller Foundation, The Lillebaelt Hospital Research Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH.	Quick-DASH (Disabilities of the Arm, Shoulder and Hand) is a patient reported questionnaire measuring upper extremity function and pain.	12 months
Secondary	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.	Registry obtained information about participants work affiliation from diagnosis to five years after inclusion.	5 years