Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-12-31

Brief Summary

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Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of effectiveness of corticosteroid injections is however contradicting. The importance of the accuracy of the steroid placement have been discussed and recently there are a few studies indicating better treatment effect if the injections are guided towards specific anatomical structures by real time ultrasound imaging. None of these studies have been double blinded. The aim of this study is to investigate the importance of placement of steroid injection in patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in the subacromial bursa using a double blinded design.

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Detailed Description

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Conditions

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Rotator Cuff Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

Local

Group Type EXPERIMENTAL

triamcinolone and lidocaine hydrochloride

Intervention Type DRUG

Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region

B

Systemic

Group Type ACTIVE_COMPARATOR

triamcinolone and lidocaine hydrochloride

Intervention Type DRUG

Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region

Interventions

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triamcinolone and lidocaine hydrochloride

Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region

Intervention Type DRUG

triamcinolone and lidocaine hydrochloride

Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region

Intervention Type DRUG

Other Intervention Names

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Xyloacain (AstraZeneca) Kenakort-T (Bristol-Myers Squibb) Kenacort-T (Bristol-Myers Squibb) Xylocain (AstraZeneca)

Eligibility Criteria

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Inclusion Criteria

* above 18 years
* shoulder pain for more than 3 months
* pain at abduction of the affected shoulder
* less than 50 % reduced passive glenohumeral range of motion in no more than one direction of either abduction, external or internal rotation
* 2 of 3 positive isometric test of external rotation, internal rotation and abduction
* positive Hawkins-Kennedy impingement test

Exclusion Criteria

* SPADI score below 30 points
* symptomatic acromioclavicular arthritis
* clinical and radiological findings indicating glenohumeral joint pathology
* referred pain from neck or internal organs
* clinical signs of a cervical syndrome
* generalized muscular pain syndrome with bilateral muscular pain in the neck and shoulders
* history of inflammatory arthritis
* diabetes mellitus type 1
* contraindications to local steroid or lidocaine hydrochloride injections
* corticosteroid injections last month before inclusion
* unable to respond to questionnaires

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No