Condition category
Musculoskeletal Diseases
Date applied
27/10/2006
Date assigned
26/01/2007
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Kane

ORCID ID

Contact details

Consultant Rheumatologist and Physician
Adelaide and Meath Hospital (Incorporating the National Children's Hospital)
Tallaght
Dublin
Dublin 24
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

K0586

Study information

Scientific title

Acronym

Study hypothesis

Intra-articular corticosteroid injections in inflammatory arthritis do not always result in clinical improvment in the joint injected, accuracy of injection may be important for a good clinical outcome. Musculoskeletal ultrasound guided injections may be more accurate than clinical examination guided injections. We therefore hypothesise that the group receiving musculoskeletal ultrasound guided intra-articular corticosteroid injections will have a better clinical outcome than the group receiving clinical examination guided injections.

Ethics approval

Initial ethical approval was given in November 2004 by Northumberland LREC (ref: 04\Q0902\34).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

All inflammatory arthritidies

Intervention

Intra-articular corticosteroid injection either guided by musculoskeletal ultrasound or clinical examination.

Intervention type

Drug

Phase

Not Specified

Drug names

Corticosteroid injection

Primary outcome measures

The primary endpoint of the study is the degree of improvement in loss of function at day 14 measured using a visual analogue scale.

Secondary outcome measures

The secondary endpoints are:
1. Clinical:
a. The degree of improvement in pain and in stiffness at day 14
b. The number of responders (patients who improve but do not relapse) at day 14
c. The degree of improvement in pain, stiffness and loss of function at six weeks
d. The number of responders at six weeks and at three months
e. The time to relapse as measured by the time from the joint injection to the first documentation of relapse of joint pain and/or stiffness (as assessed by patient and investigator)
f. Improvement in movement of joint in all planes (as assessed by gonioimeter) at day 14 and week six
g. The safety endpoint is the occurrence of tissue atrophy, nerve or vascular damage or septic arthritis

2. Radiological:
a. The number of accurately injected joints as assessed by plain radiography
b. The degree in reduction of ultrasound findings of joint effusion, synovial thickness and power Doppler signal in the injected joint

3. Laboratory:
a. The reduction in C-reactive protein at 14 days
b. The reduction in serum MMP-1 and MMP-3 at 14 days
c. The reduction in serum C-terminal telopeptide of type I collagen (CTX) (a marker of bone resorption) and N-propeptide of type I collagen (PINP) (a marker of bone formation) at 14 days

Overall trial start date

05/01/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who fulfil the American Rheumatology Association (ARA) Criteria for Rheumatoid Arthritis (RA) or have an established diagnosis of inflammatory arthritis
2. Age greater than 16 years
3. Presentation with an exacerbation of pain and/or stiffness and/or local findings of synovitis (at least two out of the three) of one of either the shoulder, elbow, wrist, knee or ankle joint (hip is excluded as we believe it should only be injected with imaging guidance)
4. Patients must be able to comply with the protocol and give their written informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

240 (90 patients in each group plus estimated 25% drop out)

Participant exclusion criteria

1. Radiological evidence of severe joint disease as assessed by previous x-ray of the affected joint
2. Patients receiving treatment for RA and not stabilised on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or corticosteroid therapy for one month or longer
3. Evidence of co-existent sepsis
4. A second joint requiring immediate corticosteroid injection
5. An acute flare of RA deemed severe enough by the patient’s supervising clinician to require an alteration in DMARD therapy
6. Use of intra-articular or intra-muscular steroids in the 28 days prior to study entry
7. Allergy to corticosteroids or contrast material

Recruitment start date

05/01/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Rheumatologist and Physician
Dublin
Dublin 24
Ireland

Sponsor information

Organisation

Newcastle Hospitals NHS Trust (UK)

Sponsor details

Freeman Hospital
Heaton Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK) (reference number 16149)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20222114

Publication citations

  1. Results

    Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D, A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis., Arthritis Rheum., 2010, 62, 7, 1862-1869, doi: 10.1002/art.27448.

Additional files

Editorial Notes