NCT00640575

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
Last Updated

July 6, 2011

Status Verified

March 1, 2005

Enrollment Period

1.6 years

First QC Date

March 9, 2008

Last Update Submit

July 3, 2011

Conditions

Rotator Cuff Disease

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Disability Index (SPADI)

    2 and 6 weeks

Secondary Outcomes (5)

  • Western Ontario Rotator Cuff Index (WORC)

    2 and 6 weeks

  • Pain in activity (7 point ordinal scale)

    2 and 6 weeks

  • Pain at rest (7 point ordinal scale)

    2 and 6 weeks

  • Change in main complaint (18 point ordinal scale)

    2 and 6 weeks

  • Active range of motion

    2 and 6 weeks

Study Arms (2)

A

EXPERIMENTAL

Local

Drug: triamcinolone and lidocaine hydrochloride

B

ACTIVE COMPARATOR

Systemic

Drug: triamcinolone and lidocaine hydrochloride

Interventions

triamcinolone and lidocaine hydrochlorideDRUG

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

Also known as: Xyloacain (AstraZeneca), Kenakort-T (Bristol-Myers Squibb)
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • of 3 positive isometric test of external rotation, internal rotation and abduction
  • positive Hawkins-Kennedy impingement test

You may not qualify if:

  • 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
  • unable to respond to questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ekeberg OM, Bautz-Holter E, Juel NG, Engebretsen K, Kvalheim S, Brox JI. Clinical, socio-demographic and radiological predictors of short-term outcome in rotator cuff disease. BMC Musculoskelet Disord. 2010 Oct 15;11:239. doi: 10.1186/1471-2474-11-239.

    PMID: 20950433DERIVED

  • Ekeberg OM, Bautz-Holter E, Tveita EK, Juel NG, Kvalheim S, Brox JI. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ. 2009 Jan 23;338:a3112. doi: 10.1136/bmj.a3112.

    PMID: 19168537DERIVED

MeSH Terms

Interventions

TriamcinoloneLidocaine

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ole M Ekeberg, MD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2008

First Posted

March 21, 2008

Study Start

March 1, 2005

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

July 6, 2011

Record last verified: 2005-03