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

ISRCTN	ISRCTN15077843
DOI	https://doi.org/10.1186/ISRCTN15077843
Protocol serial number	N/A
Sponsor	Hospital Heliópolis (Brazil)
Funder	Investigator initiated and funded (Brazil)

Submission date: 16/09/2013
Registration date: 25/09/2013
Last edited: 10/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Steroids can be used in the treatment of patients with knee osteoarthritis (arthritis of the knee), but the best agent is still unknown. This study aimed to compare the effect of two drugs (triamcinolone hexacetonide and methylprednisolone acetonide) on the condition.

Who can participate?
Men and women who are at least 40 years old, with painful knee osteoarthritis took part in this study.

What does the study involve?
Participants were randomly allocated to receive a single knee injection of either triamcinolone hexacetonide or methylprednsilone acetonide. After 24 weeks participants attended a follow-up visit to assess the effectiveness of the treatment with questionnaires.

What are the possible benefits and risks of participating?
Possible benefits were pain relief and physical function improvement. Risks were related to the injection and included pain, swelling, bleeding and infection in the knee.

Where is the study run from?
The study was run from Hospital Heliópolis, São Paulo, Brazil

When is the study starting and how long is it expected to run for?
The study started in December 2010 and ended in May 2013

Who is funding the study?
The investigators funded the study

Who is the main contact?
Dr Andrea Lomonte
avannucci@bol.com.br

Contact information

Dr Andrea Lomonte
Scientific

Rua Maria Bucalem Haddad
123, ap 52, bloco B - Vila Firmiano Pinto
Sao Paulo
04125-010
Brazil

Study information

Primary study design	Interventional
Study design	24 weeks prospective randomized two arms double-blinded study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomized, double-blind study to evaluate the efficacy of intra-articular injection of methylprednisolone versus triamcinolone hexacetonide in patients with knee osteoarthritis
Study objectives	Intra-articular injections of methylprednisolone acetate and triamcinolone hexacetonide have similar efficacy at reducing knee pain and improving physical function both in the short as in the long-term in patients with symptomatic knee osteoarthritis.
Ethics approval(s)	Research Ethics Committee of the Hospital Heliopolis [Comitê de Ética em Pesquisa do Hospital Heliópolis], 14/10/2008
Health condition(s) or problem(s) studied	Knee osteoarthritis
Intervention	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 injection) Follow-up: 24 weeks
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Methylprednisolone, triamcinolone hexacetonide
Primary outcome measure(s)	Mean change from baseline in patients assessment of pain in the targeted knee by VAS at week 4
Key secondary outcome measure(s)	1. Mean changes from baseline in patients assessment of pain by VAS at 12 and 24 weeks 2. Mean changes from baseline in patients and physicians global assessment of disease activity by VAS 3. Improvement in patients 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.
Completion date	17/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	18/12/2010
Date of final enrolment	17/05/2013

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Maria Bucalem Haddad

Sao Paulo
04125-010
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/06/2016: Publication reference added.