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