Shoulder PainNCT04686435
Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis
An observational study of Shoulder Pain and Metabolic Syndrome, run by Vejle Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Metabolic Syndrome
- What is being tested?
- Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,100 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2021to 4 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will include all patients diagnosed with a shoulder disorder at their medical examination, and have given written consent to participate.
Who may be able to join
- 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.
Who cannot join
- Significant cognitive impairment or language issues
- Symptomatic cervical spine pathology
- Older than 75 years.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Vejle Hospital, University Hospital of Southern Denmark
Vejle, Region Syddanmark, 7100
About this study
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
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).
Read the 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.
- Conditions
- Shoulder Pain, Metabolic Syndrome
- Being tested
- Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture, Surgery
- Medical subject headings
- Shoulder Pain, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupunctureOther
Also called Physiotherapy, Exercise, Corticosteroid injection, Medication
Treatment consisting of different non-surgical interventions as recommended by the orthopedic specialist and decided upon in shared decision making with the patient
SurgeryProcedure or surgery
Surgery can consist of rotator cuff repair, Bankart repair, subacromial decompression, biceps tenodesis or tenotomy, acromioclavicular joint resection.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical treatment | Shoulder patients referred for non-surgical treatment after being diagnosed at the medical examination. Receives: 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. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Registry obtained information about participants work affiliation from diagnosis to five years after inclusion.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start4 Jan 2021
- Primary completion4 Jan 2025
- Study completion4 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, The A.P. Moller Foundation, The Lillebaelt Hospital Research Foundation
- Responsible party
- Sponsor
- Investigators
- Kim G. Ingwersen, PhD, Principal investigator, Vejle Hospital, University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686435
- Sponsor's protocol ID
- VHS Cohort 20/12316
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2020
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be shared upon direct contact to principal investigator with relevant purpose.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04686435
- Acronym / sponsor ID
- VHS Cohort 20/12316
- Conditions
- Shoulder Pain, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, The A.P. Moller Foundation, The Lillebaelt Hospital Research Foundation
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 4 Jan 2025 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical treatment | – | Other: Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupunctureShoulder patients referred for non-surgical treatment after being diagnosed at the medical examination. |
| Surgical treatment | – | Procedure: SurgeryShoulder patients referred for surgical treatment after being diagnosed at the medical examination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will include all patients diagnosed with a shoulder disorder at their medical examination, and have given written consent to participate.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Significant cognitive impairment or language issues
- Symptomatic cervical spine pathology
- Older than 75 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupunctureAlso: Physiotherapy, Exercise, Corticosteroid injection, MedicationTreatment consisting of different non-surgical interventions as recommended by the orthopedic specialist and decided upon in shared decision making with the patient | Other | Non-surgical treatment |
| SurgerySurgery can consist of rotator cuff repair, Bankart repair, subacromial decompression, biceps tenodesis or tenotomy, acromioclavicular joint resection. | Procedure or surgery | Surgical treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No. Anonymized data will be shared upon direct contact to principal investigator with relevant purpose.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim G. Ingwersen, PhD principal investigator
Vejle Hospital, University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Metabolic Syndrome, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.