TRIAMCINOLONE ACETONIDE for Frozen shoulder

Inclusion criteria

• {"criterion_text":"- 1.\tShoulder pain <9 months\n- 2.\tReduced 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.\n- 3.\tShoulder pain intensity >3 on a scale from 0 (no pain) to 10 (worst possible pain) in either activity or rest (including night)\n- 4.\tAge 18 to 70 years\n- 5.\tCapable 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

• {"criterion_text":"- 1.Shoulder joint osteoarthritis\n- 2.\tBleeding disorders\n- 3.\tActive cancer or infectious disease\n- 4.Serious psychiatric or neurological disorder\n- 5.\tUsing corticosteroid tablets for other medical conditions\n- 6.\tPrior corticosteroid injection for frozen shoulder in the affected shoulder"}

Primary endpoints

• {"endpoint_text":"- Shoulder Pain and Disability Index","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Pain intensity rest and activity\n- Quick-DASH\n- EQ-5D-5L\n- Hopkins Symptom Checklist-10\n- Tampa Scale of Kinesiophobia\n- iMTA Medical Consumption Questionnaire\n- iMTA Productivity Cost Questionnaire\n- Patient Accepted Symptom State\n- Global Rating of Change scale","definition_or_measurement_approach":""}

Norway

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

196

Number Of Sites

1

Number Of Participants

180

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway