Osteoarthritis, Knee
Conditions
Interventions
This is a single-centre, double-blind, randomized, placebo-controlled clinical trial,with 1:1 allocation ratio to parallel groups (Pterodon extract treatment group - GE or placebo group - GP). Aiming
D20.215.784.500
Sponsors
Universidade Federal do Tocantins
Universidade Federal do Tocantins
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients between 40 and 80 years old will be included; of both sexes; who have a medical diagnosis of knee osteoarthritis, reports of chronic pain (pain for more than three months (TREEDE, 2015; JOHNSON, 2019) due to arthritis; who know how to read and write; and who can maintain telephone contact via mobile phone .
Exclusion criteria
Exclusion criteria: Having some cognitive impairment or psychiatric disorder that prevents the completion of the study questionnaires (self-report); be diagnosed withrheumatoid arthritis, fibromyalgia, kidney failure, liver disease and gout; have sustained a substantial knee injury within the past 6 months, have a history of arthroscopic or open surgery on the index knee within the past 12 months, or plan to undergo such a procedure within the next 3 months, have received corticosteroid injections within the past 3 months, or acid hyaluronic acid in the index knee in the last six months, who are pregnant or breastfeeding, using any medication or experimental device in the 30 days prior to randomization, or who have any disease or major medical condition that prevents the 2-month follow-up established for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected thatpatients with knee osteoarthritis treated with Pterodon extract have lower mean pain scores measured by the scaleBrief Pain Inventorywhen compared to participants in the control group.The instrument will be applied in three moments of the research: at the beginning, after four weeks of intervention and at the end of the eight weeks. It evaluates both the intensity of pain (sensory dimension) and the interference of pain in the patient's life (reactive dimension). Pain intensity should be measured by means of the average of scores in both dimensions. The diagram of pain locations and the two items on treatment are only used as a descriptive way to characterize pain and its relief. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the evolution of the functional capacity of patients with knee osteoarthritis throughout the intervention with Pterodon extract in comparison with the control group. For this purpose, the Western Ontario and McMaster Universities Osteoarthritis Index instrument will be used, consisting of 24 items divided into three subscales: pain (5 items), stiffness (2 items) and physical function (17 items). Higher WOMAC scores indicate worse pain, stiffness, and functional limitations.The instrument will be applied before and after the intervention.;An improvement in quality of life scores is expected for the group treated with Pterodon extract compared to the group treated with placebo over the eight weeks of treatment. The quality of life assessment method will be through the application of the instrument The World Health Organization Quality of Life -Brief, whose sum of scores can range from zero to 100, with the higher the value, the better the quality of life domain. | — |
Countries
Brazil
Contacts
Public ContactFabiana Stacciarini Seraphin
Universidade Federal do Tocantins
Outcome results
None listed