Overview
Sponsor-declared trial summary
Frozen shoulder
There is a need for high-quality studies evaluating the effectiveness of physiotherapy combined with intra-articular corticosteroid injections for improving shoulder function in patients with frozen shoulder. We aim to compare the effectiveness of physical therapy, corticosteroid injections, and their combination, on p…
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 12 Jan 2026 → ongoing
- Decision date (initial)
- 2025-06-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
There is a need for high-quality studies evaluating the effectiveness of physiotherapy combined with intra-articular corticosteroid injections for improving shoulder function in patients with frozen shoulder. We aim to compare the effectiveness of physical therapy, corticosteroid injections, and their combination, on pain and function at 3 months in patients with frozen shoulder.
Conditions and MedDRA coding
Frozen shoulder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Shoulder pain <9 months 2. Reduced passive range of movement in the glenohumeral joint compared with the unaffected side, more than 30 degrees for at least two of these three movements: forward flexion, abduction or external rotation. 3. Shoulder pain intensity >3 on a scale from 0 (no pain) to 10 (worst possible pain) in either activity or rest (including night) 4. Age 18 to 70 years 5. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria 1
- 1.Shoulder joint osteoarthritis 2. Bleeding disorders 3. Active cancer or infectious disease 4.Serious psychiatric or neurological disorder 5. Using corticosteroid tablets for other medical conditions 6. Prior corticosteroid injection for frozen shoulder in the affected shoulder
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Shoulder Pain and Disability Index
Secondary endpoints 1
- Pain intensity rest and activity, Quick-DASH, EQ-5D-5L, Hopkins Symptom Checklist-10, Tampa Scale of Kinesiophobia, iMTA Medical Consumption Questionnaire, iMTA Productivity Cost Questionnaire, Patient Accepted Symptom State, Global Rating of Change scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP131459 · ATC
- Active substance
- Triamcinolone Acetonide
- Substance synonyms
- 9Α-FLUORO-11Β,21-DIHYDROXY-16Α,17Α-ISOPROPYLIDENEDIOXYPREGNA-1,4-DIENE-3,20-DIONE
- Route of administration
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB08 — TRIAMCINOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP101878658 · ATC
- Active substance
- Cetrimide
- Route of administration
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 40
- Max total dose
- 40
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- John Bjørneboe
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- John Bjørneboe
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 180 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2026-01-12 | 2026-01-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol EU 2024-519728-26-00_v2_clean | 1 |
| Protocol (for publication) | D1_ Protocol EU 2024-519728-26-00_v2_tracked | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_EU 2024-519728-26-00_RFI2_clean | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_EU 2024-519728-26-00_RFI2_tracked | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_EU 2024-519728-26-006-rfi2_clean | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_EU 2024-519728-26-006-rfi2_tracked | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Lederspan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SMPC_Xylocain | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU_2024-519728-26-00 RFI002 tracked | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU_2024-519728-26-00 RFI002_clean | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-14 | Norway | Acceptable 2025-06-02
|
2025-06-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-25 | Norway | Acceptable 2025-12-04
|
2025-12-04 |