Overview

Treatment Study of Frozen Shoulder: Corticosteroid Injection in Joint Versus Wait and See Policy

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Satya Pal Sharma
Collaborator:
Norwegian Medical Association
Treatments:
Lidocaine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
Inclusion Criteria:

- Patients who on clinical examination show reduced shoulder movements with pain where
commonly lateral rotation is most restricted, medial rotation least restricted and
abduction is somewhat restricted, somewhere in between the two other movements, is
called a capsular pattern of movement confirming shoulder capsulitis

- Had had the condition for at least 2 months

- Reduction of movement is at least 30% of normal in two of the three passive movements

- Are ready to undergo treatment as set up before hand (agree to participate in one of
the three groups)

- Agree not to undergo other treatment simultaneously directed at the stiff shoulder
other than in the control group

- Patient has voluntarily given his/her written consent for participation

- Has not already received intraarticular corticosteroid injection prior to entry in the
study less than 4 weeks earlier

Exclusion Criteria:

- Diabetes, as in some diabetic patients, steroids can disturb the regulation of their
blood sugar levels.

- One of the two shoulder movements are normal, either passive abduction or passive
lateral rotation

- Have some systemic disease where use of corticosteroids is either contraindicated or
affect the coexisting disorder

- Patients with asthma using steroid inhalations or steroids orally

- There are other coexisting disorders in the arm or patient has a painful neck that can
disturb pain and functional assessment of the shoulder

- Pregnant and breast feeding mothers

- Patients under 18 years of age

- Patients who do not understand Norwegian

- Patients who have reduced intellectual capacity for consent-giving