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

U

Ullevaal University Hospital

Status

Completed

Conditions

Rotator Cuff Disease

Treatments

Drug: triamcinolone and lidocaine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00640575
sais-201204

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

106 participants in 2 patient groups

A
Experimental group
Description:
Local
Treatment:
Drug: triamcinolone and lidocaine hydrochloride
Drug: triamcinolone and lidocaine hydrochloride
B
Active Comparator group
Description:
Systemic
Treatment:
Drug: triamcinolone and lidocaine hydrochloride
Drug: triamcinolone and lidocaine hydrochloride

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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