Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Pain reduction
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1 capsular & intra-articular
corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
Intervention: Triamcinolone hexacetonide (Drug)
2 intra-articular
corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
Intervention: Triamcinolone hexacetonide (Drug)
3 placebo
placebo injections (Lidocaine) in capsule and intra-articular
Intervention: Triamcinolone hexacetonide (Drug)
Outcomes
Primary Outcomes
Pain reduction
Time Frame: 2-3 years
Secondary Outcomes
- Function (ROM, SPADI), Life quality(2-3 years)
Investigators
Tore Prestegaard
MD, consultant physician
Sykehuset i Vestfold HF