The objective of this study is to investigate the added effect of an intramuscular (IM) gluteal corticosteroid injection above a placebo IM gluteal injection (saline) on pain symptoms in patients with hip OA, not responding satisfactory to the usual…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is the severity of pain in rest and pain at walking
(NRS 0-10, 0 equals no pain) and WOMAC 3.1 pain subscale (0-100, 0 equals no
pain) at 2 weeks follow-up.
Secondary outcome
The secundary outcome measure are
1. the primary outcome measure at the other follow-up moments (4, 6, 12 weeks)
2 WOMAC 3.1 (5-point Likert) function and stiffness subscales. We will
normalize the WOMAC function and the WOMAC stiffness subscale both to a 0 to
100 score, where 0 equals no symptoms
3 patients* global assessment (with use of a 7-point Likert scale: 1 = worse
than ever to 7 = major improvement)
4 a generic measure for quality of life using Euroqol
5 difference in percentage of responders as defined by OMERACT-OARSI
6 range of motion of the index hip
7 specific adverse effects
Background summary
Recent international guidelines recommend an intra-articular corticosteroid
injection in patients with hip- or kneeOA who have moderate to severe pain not
responding satisfactorily to oral analgesic/anti-inflammatory agents. This is
an effective intervention to relieve pain temporarily. However, IA
corticosteroid injection in the hip is more painful and more complex than in
the knee, because fluoroscopic or ultrasound guidance is necessary. Therefore,
in the Netherlands, this intervention is seldom offered to patients. Recent
research indicates that a clinically relevant effect might also be present
after intramuscular corticosteroid injection, which is less complex than an IA
injection.
Study objective
The objective of this study is to investigate the added effect of an
intramuscular (IM) gluteal corticosteroid injection above a placebo IM gluteal
injection (saline) on pain symptoms in patients with hip OA, not responding
satisfactory to the usual pain medication (acetaminophen or NSAID).
Study design
A double blind randomized controlled trial with a two parallel group design and
with 12 weeks of follow-up. The randomization will be stratified for setting
(primary or secondary care) from which the patient was recruited.
Intervention
An intramuscular gluteal injection with either 40 mg triamcinolone acetate
(intervention), or saline water injection (placebo)
Study burden and risks
The participants will be given an intramuscular injection with corticosteroid
or placebo. The risks of an intramuscular corticosteroid injection are small.
Pain reduction is a possible benefit of this study. Participants are followed
up to 12 weeks in which they have to complete a questionnaire on pain and
function (VAS,WOMACscore) and on quality of life (EQ-5D) 5 times (baseline, 2,
4, 6, 12 weeks). A physical examination is planned 2 times (baseline, 12
weeks). At baseline an X-ray (Pelvic) is and a blood sample is taken (hs-CRP,
ESR).
Participants are requested to keep a daily pain and painmedication dairy up to
2 weeks after injection.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. A diagnosis of hip OA according to the cinical ACR criteria, including radiologic evidence of OA (kellgren-lawrence grading greater or equal than 2)
2. age > 40 years
3. Symptomatic disease for at least 6 months prior to enrolment
4. Persistent pain despite receiving normal pain medication (acetaminophen and/or NSAID) for at least 3 weeks. Pain severity (in rest or on walking) defined as a minimum score of 3 on the Numerical Rating Scale (NRS; 0-10 range)
Exclusion criteria
Local or systemic infection precluding injection, diabetes mellitus, systemic arthritis, allergy to corticosteroid agent, use of oral corticosteroids, coagulopathy, anticoagulant therapy (cumarin type), peptic ulcer, previous intra-articular steroid injection into the index hip in the past 6 months, radiographic signs of osteonecrosis, pregnancy, lactating women, participation in other medical trials and on the waiting list for a hip replacement surgery
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 | EUCTR2011-000213-39-NL |
| CCMO | NL35353.078.11 |