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
Protocol serial number	K0586
Sponsor	Newcastle Hospitals NHS Trust (UK)
Funder	Arthritis Research Campaign (UK) (reference number 16149)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Initial ethical approval was given in November 2004 by Northumberland LREC (ref: 04\Q0902\34).
Health condition(s) or problem(s) studied	All inflammatory arthritidies
Intervention	Intra-articular corticosteroid injection either guided by musculoskeletal ultrasound or clinical examination.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Corticosteroid injection
Primary outcome measure(s)	The primary endpoint of the study is the degree of improvement in loss of function at day 14 measured using a visual analogue scale.
Key secondary outcome measure(s)	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
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	05/01/2005
Date of final enrolment	01/10/2006

Locations

Countries of recruitment

United Kingdom
Ireland

Study participating centre

Consultant Rheumatologist and Physician

Dublin
Dublin 24
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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