A study to compare the efficacy of intra-articular injection of methylprednisolone versus triamcinolone hexacetonide in patients with knee osteoarthritis

Not Applicable

Completed

Conditions: Knee osteoarthritis
Musculoskeletal Diseases

Registration Number: ISRCTN15077843

Lead Sponsor: Hospital Heliópolis (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Diagnosis of knee osteoarthritis (OA) according to the American College of Rheumatology criteria
2. Kellgren-Lawrence radiographic grade II or III of the knee
3. Visual analogue scale (VAS) for knee pain of at least 40mm (maximum 100mm)
4. Both genders, aged 40 years or older
5. Failure to control OA symptoms with previous or current analgesics and/ or non steroidal antiinflammatory drugs

Exclusion Criteria

1. Other rheumatic or inflammatory condition
2. Symptomatic disease of the lower limbs (other than knee OA)
3. Serious and/or uncontrolled concomitant medical illness
4. Body mass index (BMI) greater or equal to 35kg/m2
5. IA injection of corticosteroid or hyaluronic acid in the previous 6 months
6. knee replacement in the targeted joint
7. Local or systemic infection
8. Pregnancy
9. Skin lesions in the IA injection site
10. Physical therapy for the knee
11. Known hypersensitivity to corticosteroids or lidocaine; and the use of anticoagulants

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in patient?s assessment of pain in the targeted knee by VAS at week 4

Secondary Outcome Measures

Name	Time	Method
1. Mean changes from baseline in patient?s assessment of pain by VAS at 12 and 24 weeks<br>2. Mean changes from baseline in patient?s and physician?s global assessment of disease activity by VAS<br>3. Improvement in patient?s global assessment of disease by Likert scale<br>4. Mean changes from baseline in total Western Ontario and McMaster Universities (WOMAC) questionnaire and its subscores of pain, stiffness and physical function<br>5. Mean changes from baseline in total Lequesne algofunctional index<br>6. Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) response criteria<br>7. Analysis of predictors of response<br><br>All secondary outcomes were measured at 4, 12 and 24 weeks.