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

A randomized, double-blind study to evaluate the efficacy of intra-articular injection of methylprednisolone versus triamcinolone hexacetonide in patients with knee osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15077843

Enrollment

100

Registered

2013-09-25

Start date

2010-12-18

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases Knee osteoarthritis

Interventions

1. Intra-articular triamcinolone hexacetonide 40mg single dose 2. Intra-articular methylprednisolone acetate 40mg single dose Total duration of the study: 24 weeks Intervention was one day (single

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026