Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840229
• Other study ID #: S-08546
• Secondary ID: REKInterne tjene
• Status: Completed
• Phase: N/A
• First received: February 8, 2009
• Last updated: November 24, 2013
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

Description:

3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Triamcinolone hexacetonide
20 mg
• Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml

Locations

Country	Name	City	State
Norway	Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation	Stavern

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction		2-3 years	No
Secondary	Function (ROM, SPADI), Life quality		2-3 years	No