Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

University of Oslo (UIO)

Status: Completed

Conditions: Adhesive Capsulitis

Treatments: Drug: Triamcinolone hexacetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT00840229

Interne tjenester (Other Identifier)

S-08546

IT-avdelingen (Other Identifier)

REK (Registry Identifier)

Rikshospitalet HF (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 122 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 3 patient groups, including a placebo group

1 capsular & intra-articular

Experimental group

Description:

corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular

Treatment:

Drug: Triamcinolone hexacetonide

Drug: Triamcinolone hexacetonide

2 intra-articular

Active Comparator group

Description:

corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule

Treatment:

Drug: Triamcinolone hexacetonide

Drug: Triamcinolone hexacetonide

3 placebo

Placebo Comparator group

Description:

placebo injections (Lidocaine) in capsule and intra-articular

Treatment:

Drug: Triamcinolone hexacetonide

Drug: Triamcinolone hexacetonide