Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

Study Overview
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Brief Summary
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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

Detailed Description
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3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

Official Title
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Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Drug: Triamcinolone hexacetonide
* Drug: Triamcinolone hexacetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain and stiffness in one shoulder 1 - 6 months Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder Exclusion Criteria: Systemic inflammatory disease Corticosteroid treatment last 3 months Poorly controlled Diabetes mellitus Pregnancy Contraindications/allergy to corticosteroids and/or Lidocaine Severe infections Osteoarthritis of the shoulder Fractures of the shoulder Rotator cuff pathology causing pain or disability Fibromyalgia Not able to understand Norwegian

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 capsular & intra-articular<br>corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular | Drug: Triamcinolone hexacetonide<br>* 1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml<br>|
| Active Comparator: 2 intra-articular<br>corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule | Drug: Triamcinolone hexacetonide<br>* 1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml<br>|
| Placebo Comparator: 3 placebo<br>placebo injections (Lidocaine) in capsule and intra-articular | Drug: Triamcinolone hexacetonide<br>* 20 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction |  | 2-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function (ROM, SPADI), Life quality |  | 2-3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesive capsulitis, corticosteroids, injection, pain