Comparative effects of Viscosupplementation and Triamcinolone on quality of life in patients with Knee Osteoarthritis

Viscosupplementation and Triancinolone: impact on the quality of life of patients with Knee Osteoarthritis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-2mxrcjw

Enrollment

Unknown

Registered

2025-11-17

Start date

2024-01-01

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Quality of life

Interventions

This will be a longitudinal, non-randomized intervention study to evaluate the impact of combined sodium hyaluronate and triamcinolone hexacetonide therapy on the quality of life of patients with knee

Eligibility

Age

45 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes aged 45 or older. Diagnosis of symptomatic osteoarthritis (OA) of the knee. Diagnosis confirmed by radiological examination. Must have sought outpatient care between January and March 2023

Exclusion criteria

Exclusion criteria: History of knee surgery or trauma. Use of oral chondroprotectors in the past year. Having received corticosteroid injections in the past year. Having undergone viscosupplementation in the past year

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: An improvement in knee pain, stiffness, and function is expected, verified by a significant reduction in the scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, assessed at 3, 6, and 12 months post-intervention, compared to the baseline assessment;Outcome found 1: A statistically significant improvement (p < 0.01) was observed in knee pain, stiffness, and function, as measured by the WOMAC questionnaire scores. The most pronounced reduction in symptoms occurred between the baseline assessment (T0) and 3 months (T3), with the improvement being sustained at 6 months (T6). The effect size (Cohen's d) for the overall improvement in WOMAC scores was 2.10, indicating a large effect	—

Measure

Time frame

Expected outcome 1: An improvement in knee pain, stiffness, and function is expected, verified by a significant reduction in the scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, assessed at 3, 6, and 12 months post-intervention, compared to the baseline assessment;Outcome found 1: A statistically significant improvement (p < 0.01) was observed in knee pain, stiffness, and function, as measured by the WOMAC questionnaire scores. The most pronounced reduction in symptoms occurred between the baseline assessment (T0) and 3 months (T3), with the improvement being sustained at 6 months (T6). The effect size (Cohen's d) for the overall improvement in WOMAC scores was 2.10, indicating a large effect

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Secondary

Measure	Time frame
Expected outcome 2:An improvement in the patients' perception of quality of life is expected, assessed by an increase in the scores of the World Health Organization Quality of Life – WHOQOL-bref questionnaire, at 3, 6, and 12 months post-intervention, compared to the baseline assessment;Outcome found2: A statistically significant improvement (p < 0.01) in overall quality of life was observed, verified by an increase in the WHOQOL-bref questionnaire scores between the baseline assessment (T0) and the 3-month (T3) and 6-month (T6) follow-up assessments. The effect size (Cohen's d) for the improvement in quality of life was 1.18, which is considered a large effect	—

Measure

Time frame

Expected outcome 2:An improvement in the patients' perception of quality of life is expected, assessed by an increase in the scores of the World Health Organization Quality of Life – WHOQOL-bref questionnaire, at 3, 6, and 12 months post-intervention, compared to the baseline assessment;Outcome found2: A statistically significant improvement (p < 0.01) in overall quality of life was observed, verified by an increase in the WHOQOL-bref questionnaire scores between the baseline assessment (T0) and the 3-month (T3) and 6-month (T6) follow-up assessments. The effect size (Cohen's d) for the improvement in quality of life was 1.18, which is considered a large effect

—

Countries

Brazil

Contacts

Public ContactAnderson Labbado

Universidade Estadual de Maringá

andersonlabbado@hotmail.com+55-044-30114564

Outcome results

None listed

Source: REBEC (via WHO ICTRP)