Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000127303
Ethics application status
Approved
Date submitted
22/02/2008
Date registered
10/03/2008
Date last updated
10/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of chronically inflamed knee joints with aspiration and corticosteroid injection
Scientific title
The effects of knee joint aspiration and corticosteroid injection on quadriceps muscle performance, flexion reflex excitability and lower limb function in patients with chronic arthritis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory arthritis of the knee joint 2861 0
Condition category
Condition code
Inflammatory and Immune System 2994 2994 0 0
Rheumatoid arthritis
Inflammatory and Immune System 2995 2995 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aspiration and a single dose intra-articular injection of 40mg Depomedrol. Participants will be followed up for 2 weeks after corticosteroid injection.
Intervention code [1] 2590 0
Treatment: Drugs
Intervention code [2] 2591 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3875 0
Quadriceps muscle function - peak isometric torque, electromyography (EMG) amplitude and muscle fibre conduction velocity
Timepoint [1] 3875 0
Baseline, post aspiration, 4 days post intervention, 2 weeks post intervention
Primary outcome [2] 3876 0
Lower limb function - self report questionnaires, 10 metre walk test, 6 minute walk test.
Timepoint [2] 3876 0
Baseline, 4 days post intervention, 2 weeks post intervention
Primary outcome [3] 3877 0
Flexion reflex excitability - threshold, Area under the curve at 1.2 x threshold
Timepoint [3] 3877 0
Baseline, post aspiration, 4 days post intervention, 2 weeks post intervention
Secondary outcome [1] 6521 0
Pain - Visual analogue scale (VAS)
Timepoint [1] 6521 0
Baseline, 4 days post intervention, 2 weeks post intervention

Eligibility
Key inclusion criteria
1. A primary diagnosis of inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, crystal arthritis.
2. A clinically detectable knee joint effusion as well as other clinical signs and symptoms of knee joint synovitis including pain on motion, heat and tenderness on palpation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Recent history of an intra-articular corticosteroid injection to the knee joint.
2.Any medical condition that may preclude the performance of maximum effort strength tests.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 800 0
New Zealand
State/province [1] 800 0
Auckland

Funding & Sponsors
Funding source category [1] 3112 0
University
Name [1] 3112 0
AUT University
Country [1] 3112 0
New Zealand
Funding source category [2] 3113 0
Government body
Name [2] 3113 0
Health Research Council
Country [2] 3113 0
New Zealand
Funding source category [3] 3114 0
Government body
Name [3] 3114 0
Accident Compensation Corporation
Country [3] 3114 0
New Zealand
Primary sponsor type
University
Name
AUT University
Address
55 Wellesly Street East
Auckland
Country
New Zealand
Secondary sponsor category [1] 2801 0
Government body
Name [1] 2801 0
Accident Compensation Corporation
Address [1] 2801 0
81-83 Molesworth Street
Wellington
Country [1] 2801 0
New Zealand
Secondary sponsor category [2] 2802 0
Government body
Name [2] 2802 0
Health Research Council
Address [2] 2802 0
110 Stanley Street
Auckland
Country [2] 2802 0
New Zealand
Other collaborator category [1] 211 0
University
Name [1] 211 0
University of Auckland
Address [1] 211 0
Park Road
Grafton
Auckland
Country [1] 211 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5090 0
Northern Regional Ethics Committee
Ethics committee address [1] 5090 0
Auckland
Ethics committee country [1] 5090 0
New Zealand
Date submitted for ethics approval [1] 5090 0
04/08/2007
Approval date [1] 5090 0
12/08/2007
Ethics approval number [1] 5090 0
NTX/06/08/089

Summary
Brief summary
Joint disease often leads to an ongoing, reflex weakness of muscles acting across the damaged joint. This process is thought to occur at a spinal cord level and is called Arthrogenic Muscle Inhibition (AMI). At the knee joint, the quadriceps (the muscles at the front of the thigh) are preferentially affected by AMI. The quadriceps have an important protective function to the knee joint. Weakness and dysfunction due to AMI may reduce the shock attenuating ability of the muscles, increasing the forces acting at the knee and predisposing chronic arthritic joints to further injury or damage. While a number of studies have investigated the effects of swelling and joint disease on quadriceps function, few have looked at ways to overcome this problem. The purpose of this study is to measure changes in quadriceps muscle function, spinal reflex excitability and patients’ ability to perform day-to-day tasks after 1.) withdrawing fluid from their knee joints and then 2.) injecting a corticosteroid (an anti-inflammatory drug) into their joint. Results from the current study will provide important information concerning the mechanisms behind AMI and the rehabilitation of patients with chronic arthritic disease of the knee joint.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28394 0
Address 28394 0
Country 28394 0
Phone 28394 0
Fax 28394 0
Email 28394 0
Contact person for public queries
Name 11551 0
Jane Galle
Address 11551 0
Health and Rehabilitation Research Centre
AUT University
Private Bag 92006
Auckland
Country 11551 0
New Zealand
Phone 11551 0
+64 99219999 ext. 7194
Fax 11551 0
Email 11551 0
[email protected]
Contact person for scientific queries
Name 2479 0
David Rice
Address 2479 0
Health and Rehabilitation Research Centre
AUT University
Private Bag 92006
Auckland
Country 2479 0
New Zealand
Phone 2479 0
+64 99219999 ext. 7032
Fax 2479 0
Email 2479 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.