To determine whether doubling the dose of corticosteroid injections in the treatment of arthritis in knee joints is more effective in the relief of symptoms as measured by change in the assessment of arthritis burden by the patient on a Likert 5-…
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Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: percentage of patients with sustained good response; i.e.
symptomatic relief after local corticosteroid injection in knee joint, measured
as a difference (a positive change of at least 2 points on a 5 point scale)
between t = 0 and t = 12 weeks on a 5 point Likert scale (Burden of arthritis
symptoms: very much, much, moderate, little, none; as determined by a question
to the patient, see CRF) at at least 2 consecutive weeks including week 12, for
each included patient.
Secondary outcome
-% of patients with good response in symptomatic relief at individual weekly
time points (at t = 2,3,4,5,6,7,8,9,10,11 weeks) measured as the difference
between the time point and t= 0 on the 5 point Likert scale (Burden of
arthritis symptoms: very much, much, moderate, little, none)
-Duration of response: time lapsed between reaching good response (positive
change of at least 2 points) and consecutive loss of response defined as an
ensuing negative change of at least 2 points on the 5 point Likert scale
-Time to good response (at least two points on the 5 point Likerts scale on at
least two consecutive weeks)
-Asessment of arthritis activity by the trial physician on a 5 point Likert
scale (very active, active, moderately active, slightly active, no activity)
-VAS pain at t = 0 and t = 12 weeks
-Change of Range of Motion (ROM) on physical examination, as determined by the
trial physician on T=0 and T=12 weeks, measured in degrees with a protractor
-Change of swelling on physical examination, as determined by the trial
physician on T=0 and T=12 weeks. Swelling will be measured as *yes* or *no*.
Doubtful or little swelling will be scored as *no*.
-Change in patients health status by making use of The Western Ontario McMaster
Universities Osteoarthritis index (WOMAC) at t = 0 and t = 12 weeks.
-Corticosteroid receptor measurements at t=12 in serum (10 ml of whole blood)
Background summary
Injections of corticosteroids are widely practised in rheumatology.
Corticosteroid injections with long-lasting crystalline suspensions (depot
formulations) have been used to treat arthritis and other painful
musculoskeletal conditions since the 1950s. Their continuing use can be
attributed to their safety record and the prompt, often substantial relief that
they can provide patients. Different kinds of corticosteroids are used for
local injection. Among the Dutch rheumatologists the most frequently used local
corticosteroid is triamcinoloneacetonide (66%). Although local corticosteroid
injections are widely practised, there are only few studies published in
relationship with the response in pain relief and duration of pain relief on
therapy. Factors predicting the response in pain relief of local corticosteroid
injections are therefore largely unknown. Guidelines in dosage of local
corticosteroids in different joints are lacking. A clinical dose-effect
relationship has not yet been properly studied. The dosage being administered
is currently determined by clinical tradition. Recent study among Dutch
rheumatologists shows that different rheumatologists inject different amounts
of different corticosteroids in joints. The dosages corticosteroid that are
given in joints can differ between rheumatologists up to 100%. A comparison
between the dosage of the corticosteroids and responses should be investigated
to optimalize treatment in pain relief and duration of pain relief by injection
with local corticosteroid.
A higher concentration of local corticosteroid could be related with a greater
relief of symptoms in pain. A higher amount of drug in the target compartment
should lead to a prolonged local effect. In this study a comparison is being
made between the response in relief of symptoms among patients with a
conventional dosage (conventional dosage based on recent study) and a double
dose of triamcinolone, with the overall question: does a higher dose of
triamcinolone give better effect both measured in response in symptomatic
relief and duration of pain relief? In theory a higher concentration of local
corticosteroid could be more effective.
For patients with arthritis who fail to gain adequate relief from oral
medications and non-pharmacological treatments, intra-articular corticosteroid
injections are one of the few alternative nonsurgical adjunctive therapies
available.2-5 Intra-articular corticosteroid injections have demonstrated an
excellent safety record over many years and are described by the American
College of Rheumatology (ACR) as *safe and effective when administered by an
experienced physician.*5 As with any pharmacologic agent, however,
corticosteroids do have side effects in general, such as systemic effects and
flushing. These side-effects can be minimised when steroids are administered
locally as an injection in the treatment of arthritis.
Study objective
To determine whether doubling the dose of corticosteroid injections in the
treatment of arthritis in knee joints is more effective in the relief of
symptoms as measured by change in the assessment of arthritis burden by the
patient on a Likert 5-point scale, both in number of responding patients and in
duration of response.
Study design
Double-blinded randomized trial
Intervention
none
Study burden and risks
Risks of participating is negligible as the dosage of local corticosteroids is
currently practised as determined in recent study and as is also investigated
as shown in investigated brochure (see references). Risk of premature
termination of the study is therefore negligible. Subjects will be contacted
at least within 28 days after study discharge/withdrawal for safety follow-up
purposes
boerhaavelaan 63
7555 BB
NL
boerhaavelaan 63
7555 BB
NL
Listed location countries
Age
Inclusion criteria
•Arthritis patients, RA or other causes of chronic arthritis (not osteoarthritis and not gout) with an indication for local injection with corticosteroid due to active arthritis in knee joint.
•Patients should have stable anti-arthritic co-medication, no changes will be made during the trial.
•Patients need to score at least *matig* at a 5-point Likert scale at the initial questionnaire at t = 0 otherwise no significant difference can be measured.
Exclusion criteria
•Contraindication for local injection with corticosteroid (infection, relevant skin lesion, uncontrolled diabetes mellitus)
•Chronic (>3 months) or current use of more than 10mg prednisolone or equivalent daily.
•No informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-018187-10-NL |
| CCMO | NL31058.044.10 |