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Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00840229
Enrollment
122
Registered
2009-02-10
Start date
2009-02-28
Completion date
2012-06-30
Last updated
2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis, corticosteroids, injection, pain

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.

Interventions

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Pain reduction2-3 years

Secondary

MeasureTime frame
Function (ROM, SPADI), Life quality2-3 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026