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 |
| Secondary identifying numbers | N/A |
- 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
Plain English Summary
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
Scientific
Rua Maria Bucalem Haddad
123, ap 52, bloco B - Vila Firmiano Pinto
Sao Paulo
04125-010
Brazil
Study information
| Study design | 24 weeks prospective randomized two arms double-blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methylprednisolone, triamcinolone hexacetonide |
| Primary outcome measure | Mean change from baseline in patients assessment of pain in the targeted knee by VAS at week 4 |
| Secondary outcome measures | 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. |
| Overall study start date | 18/12/2010 |
| Overall study end date | 17/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 18/12/2010 |
| Recruitment end date | 17/05/2013 |
Locations
Countries of recruitment
- Brazil
Study participating centre
04125-010
Brazil
Sponsor information
Hospital/treatment centre
Rua Cônego Xavier
276 - Sacomã
Sao Paulo
04231-902
Brazil
"ROR" |
https://ror.org/01bkdwe73 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
10/06/2016: Publication reference added.
