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 |
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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
Scientific
Consultant Rheumatologist and Physician
Adelaide and Meath Hospital (Incorporating the National Children's Hospital)
Tallaght
Dublin
Dublin 24
Ireland
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 05/01/2005 |
Completion date | 01/10/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 240 (90 patients in each group plus estimated 25% drop out) |
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
- Ireland
- United Kingdom
Study participating centre
Consultant Rheumatologist and Physician
Dublin
Dublin 24
Ireland
Dublin 24
Ireland
Sponsor information
Newcastle Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Freeman Hospital
Heaton Road
Newcastle upon Tyne
NE7 7DN
England
United Kingdom
Website | http://www.newcastle-hospitals.org.uk/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/07/2010 | Yes | No |