Knee Osteoarthritis
Conditions
Brief summary
Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients. Goal: Primary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis. Secondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients. Methods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by blind evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler). Statistics: The following statistical tests will be used according to the need: Student's t test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.
Interventions
PROCEDUREplatelet rich plasm
intra-articular infiltration with platelet rich plasm
intra-articular infiltration withTriamcinolone Hexacetonide
PROCEDUREIsotonic Saline Solution
intra-articular infiltration with Isotonic Saline Solution
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary knee osteoarthritis * degree II and II in Kellgren & Lawrence classification * pain duration: more than three months * pain in the visual analogue scale between 4 and 8cm * agree in participate and sign the consent form
Exclusion criteria
* secondary knee osteoarthritis * skin lesion in knee * intraarticular joint injection in the previous three months * steroids use in the previous 30 days * degree I or IV in Kellgren & Lawrence classification * inflammatory arthritis, gout and pseudo-gout * cancer * previous surgery in knee * cardiovascular and respiratory disease that change functional status * pregnancy and breastfeed * coagulation disturb * bacterial infection * handicapped * NSAIDs and Platelet anticoagulant in the previous month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain | Baseline, after 4, 8, 12 and 48 weeks | Evaluated using a visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in range of motion | Baseline, after 4, 8, 12 and 48 weeks | Evaluated using goniometry |
| Change in a clinical improvement scale | Baseline, after 4, 8, 12 and 48 weeks | Evaluated using an improvement scale |
| Change in joint edema | Baseline, after 4, 8, 12 and 48 weeks | Evaluated using a visual analogue scale |
| Change in functional capacity | Baseline, after 4, 8, 12 and 48 weeks | Using the WOMAC questionnaire |
| Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler | Baseline, after 4, 8, 12 and 48 weeks | Using an ultrasound exam |
| Change in quality of life | Baseline, after 4, 8, 12 and 48 weeks | Using the SF-36 questionnaire |
Countries
Brazil
Outcome results
None listed