Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- Pain and stiffness in one shoulder 1 - 6 months
- Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder
- 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
Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation🇳🇴Stavern, Norway