Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

Not Applicable

Completed

• Conditions: Adhesive Capsulitis
• Interventions: Drug: Triamcinolone hexacetonide

• Registration Number: NCT00840229
• Lead Sponsor: Oslo University Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-08
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-24
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 capsular & intra-articular	Triamcinolone hexacetonide	corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
2 intra-articular	Triamcinolone hexacetonide	corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
3 placebo	Triamcinolone hexacetonide	placebo injections (Lidocaine) in capsule and intra-articular

Primary Outcome Measures

Name	Time	Method
Pain reduction	2-3 years

Secondary Outcome Measures

Name	Time	Method
Function (ROM, SPADI), Life quality	2-3 years

Trial Locations

Locations (1)

Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation; 🇳🇴 Stavern, Norway