Intramuscular corticosteroid injection in hip osteoarthritis: a randomized controlled trial

Intramuscular corticosteroid injection in hip osteoarthritis: a randomized controlled trial - HOCI study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39512

Enrollment

135

Registered

2011-03-21

Start date

2011-10-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative hip arthritis degenerative hip joint disease

Interventions

An intramuscular gluteal injection with either 40 mg triamcinolone acetate (intervention), or saline water injection (placebo)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)