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 measure
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 (if study stopped)
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 patients 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
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20222114
Publication citations
-
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.