Condition category
Musculoskeletal Diseases
Date applied
16/09/2013
Date assigned
25/09/2013
Last edited
10/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrea Lomonte

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

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

Research Ethics Committee of the Hospital Heliopolis [Comitê de Ética em Pesquisa do Hospital Heliópolis], 14/10/2008

Study design

24 weeks prospective randomized two arms double-blinded study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Methylprednisolone, triamcinolone hexacetonide

Primary outcome measures

Mean change from baseline in patient’s assessment of pain in the targeted knee by VAS at week 4

Secondary outcome measures

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.

Overall trial start date

18/12/2010

Overall trial end date

17/05/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

Trial participating centre

Rua Maria Bucalem Haddad
Sao Paulo
04125-010
Brazil

Sponsor information

Organisation

Hospital Heliópolis (Brazil)

Sponsor details

Rua Cônego Xavier
276 - Sacomã
Sao Paulo
04231-902
Brazil

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26136485

Publication citations

Additional files

Editorial Notes

10/06/2016: Publication reference added.