A randomised, double-blinded, controlled trial of ultrasound guided and conventional clinical examination guided intra-articular corticosteroid injection of large and medium synovial joints in inflammation arthritis

ISRCTN ISRCTN75459849
DOI https://doi.org/10.1186/ISRCTN75459849
Secondary identifying numbers K0586
Submission date
27/10/2006
Registration date
26/01/2007
Last edited
28/04/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Kane
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesIntra-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(s)Initial ethical approval was given in November 2004 by Northumberland LREC (ref: 04\Q0902\34).
Health condition(s) or problem(s) studiedAll inflammatory arthritidies
InterventionIntra-articular corticosteroid injection either guided by musculoskeletal ultrasound or clinical examination.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Corticosteroid injection
Primary outcome measureThe 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 measuresThe 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 study start date05/01/2005
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants240 (90 patients in each group plus estimated 25% drop out)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment05/01/2005
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Ireland
  • United Kingdom

Study participating centre

Consultant Rheumatologist and Physician
Dublin
Dublin 24
Ireland

Sponsor information

Newcastle Hospitals NHS Trust (UK)
Hospital/treatment centre

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

Website http://www.newcastle-hospitals.org.uk/
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Charity

Arthritis Research Campaign (UK) (reference number 16149)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2010 Yes No