Aged
Conditions
Interventions
This is a three-arm randomized controlled clinical trial with a 6-month evaluation period. Simple randomization was performed using an electronically generated table, dividing the patients into: G1 -
G2 - group that performed IIA with 3ml of saline solution followed by the same PRSP (n=23 performed /52 predicted) and G3 - group that performed IAI placebo, followed by the same PRSP (n=18 performed
E02.760.169.063.500.387.875
Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Both genders; Age equal to or greater than 60 years; Diagnosis of Osteoarthritis of the knee according to American College of Rheumatology criteria (Altman et al. 2000), diagnosed by a rheumatologist; Kellgren/Lawrence radiographic classification (0-IV) between II and III (Kellgren, Lawrence, 1957); Pain between 4 and 8 centimeters on the 10 centimeter numerical pain scale in at least one knee; Symptom duration for more than 3 months; Stable medication for knee osteoarthritis in the last 3 months; Agreement and signature of the free and informed consent form for this study.
Exclusion criteria
Exclusion criteria: They were diagnosed with inflammatory arthritis, gout, pseudogout, fibromyalgia, psychopathies and decompensated cardiopathies or neuropathies that affected the lower limbs; Diabetes mellitus or decompensated systemic arterial hypertension; Physiotherapy or acupuncture in the last 3 months; Initiated or changed regular physical activity in the last three months; Started or changed use of walking aids in the last three months; Skin lesion that prevented intra-articular injection in the knee to be studied; intra-articular injection with corticosteroids or hyaluronic acid derivative in the studied knee in the last 3 months and in any other joint in the last month; Previous or scheduled surgery for the next 6 months; Severe clotting disorder; Suspected bacterial infection of any nature; Difficulty in locomotion and understanding/taking the tests; litigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: It is expected to find a difference of 2 centimeters after 2 weeks of intervention, verified through the Numerical Pain Scale (END), on a scale from 0 to 10 centimeters, both at rest and when the studied knee moves.;Outcome 1: Improvement in pain on movement was observed over time from 2 weeks of intervention, measured by the Numerical Pain Scale. In relation to pain at rest, all groups improved over time, except for Group 3, in 2 weeks of intervention. At other times, it improved in the same way as the other groups over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: A decrease in knee circumference, measured in cm, is expected to be found after 2 weeks of intra-articular injection intervention. This measurement was performed by measuring the circumference of the knee studied using a flexible measuring tape 150 centimeters (cm) long.;Outcome 2: We found no differences in this outcome in any of the groups and times evaluated, through the evaluation of the measurement in centimeters of the studied knee circumference.;Expected Outcome 3: An increase, in kilograms, in muscle strength is expected, performed by calculating a maximum repetition (1RM), which indicates the maximum load that is sustained in one repetition, from 6 weeks of intervention.;Outcome 3: The 3 groups showed an increase in muscle strength, measured by 1RM in all muscle groups after 2 weeks of intervention.;Expected Outcome 4: A decrease in the total score and in the subscales (pain, stiffness and function) is expected from 2 weeks of intervention on the WOMAC questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index), which is a specific instrument for OA that assesses 3 items: knee and hip joint pain, function and stiffness.;Outcome 4: The 3 groups decreased the total score and subscales (pain, function and stiffness) of the WOMAC questionnaire (Western Ontario and McMaster Universities Osteoarthritis Index) after 2 weeks of intervention.;Expected Outcome 5: An increase in the score of each of the 8 domains of the SF-36 questionnaire is expected after 2 weeks of intervention. SF-36 (Short-form 36 questionnaire) is a generic quality of life instrument, validated for Portuguese with 36 questions covering 8 domains, including aspects related to general health, physical and emotional aspects.;Outcome 5: We found improvement in the scores of all quality of life domains, except for the vitality domain, for the 3 groups after 2 weeks of intervention, assessed by the SF-36 (Short-form 36 questionnaire).;Expected outcome 6: A decrea | — |
Countries
Brazil
Contacts
Public ContactAnamaria Jones
Universidade Federal de São Paulo
Outcome results
None listed