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| ID | Type | Description | Link |
|---|---|---|---|
| REK | Registry Identifier | S-08546 | |
| Interne tjenester | Other Identifier | ||
| IT-avdelingen | Other Identifier | 2008/5000 | |
| Rikshospitalet HF | Other Identifier |
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The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.
Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).
0-hypothesis: no difference between the methods.
The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections
3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 capsular & intra-articular | Experimental | corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular |
|
| 2 intra-articular | Active Comparator | corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule |
|
| 3 placebo | Placebo Comparator | placebo injections (Lidocaine) in capsule and intra-articular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone hexacetonide | Drug | 20 mg |
| |
| Triamcinolone hexacetonide |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | 2-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Function (ROM, SPADI), Life quality | 2-3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tore A Prestgaard, MD | The Hospital of Vestfold | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation | Stavern | 3294 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25919473 | Derived | Prestgaard T, Wormgoor MEA, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015 Sep;156(9):1683-1691. doi: 10.1097/j.pain.0000000000000209. |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C005900 | triamcinolone hexacetonide |
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| Drug |
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |