Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis

NCT04686435 | Completed

• 1 other identifier: VHS Cohort 20/12316
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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).

Conditions

Shoulder Pain; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 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.

  5 years

Study Arms (2)

Non-surgical treatment

Shoulder patients referred for non-surgical treatment after being diagnosed at the medical examination.

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

Surgical treatment

Shoulder patients referred for surgical treatment after being diagnosed at the medical examination.

Procedure: Surgery

Interventions

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

Also known as: Physiotherapy, Exercise, Corticosteroid injection, Medication, Acupuncture

Non-surgical treatment

Surgery PROCEDURE

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

Surgical treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead
• Region of Southern Denmark: collaborator
• The A.P. Moller Foundation: collaborator
• The Lillebaelt Hospital Research Foundation: collaborator

Study Sites (1)

Vejle Hospital, University Hospital of Southern Denmark

Vejle, Region Syddanmark, 7100, Denmark

Location

MeSH Terms

Conditions

Shoulder Pain; Metabolic Syndrome

Interventions

Physical Therapy Modalities; Exercise; Adrenal Cortex Hormones; Dosage Forms; Acupuncture Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Complementary Therapies

Study Officials

• Kim G. Ingwersen, PhD

  Vejle Hospital, University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 4, 2021
• Primary Completion: January 4, 2025
• Study Completion: January 4, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)