Effectiveness of previous use of Intra-Articular Corticosteroid Injection in Elderly patients with knee Osteoarthritis undergoing a Progressive Resistance Exercise Program: a randomized controlled trial
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
Background: Osteoarthritis (OA) is highly prevalent in the elderly. Both IIA with triancinolone hexacetonide (TH) and the prescription of resistance exercise are frequent practices that have been proven to be effective in the management of patients with knee OA. However, there are no studies that evaluate the effectiveness of the association of these two interventions in these patients. Objective: To evaluate the effectiveness of the association of IIA CE with a PPRE in improving pain, function, muscle strength and quality of life in elderly patients with knee OA. Methods: Elderly patients diagnosed with knee OA, both genders, with pain between 4 and 8 cm on a 10 cm numerical pain scale, having symptoms for at least 3 months and stable medication for OA for 3 months were included. The elderly were randomized into 3 intervention groups: IIA CE + PPRE, IIA SS + PPRE and IIA placebo + PPRE. The PPRE was performed for 12 weeks, twice a week. Assessments of pain (NPS), function (WOMAC), quality of life (SF-36), and performance tests (6' walk test, TUGT, FTSS and SPPB) were performed at baseline, 2, 6, and 12 weeks after IIA by a blinded evaluator. Results: Due to the epidemiological crisis (COVID-19), only 15 patients were allocated to each group. In the initial evaluation, the groups were homogeneous for all parameters. Intergroup analysis, using repeated measures ANOVA, found no statistically significant difference between groups over time for all variables of pain, function, quality of life, and functional tests. In the intragroup analysis, there was an improvement in the NPS for the 3 groups (p<0.001) over time, WOMAC (all domains (p<0.001)), 1RM (p<0.001), SPPB (<0.007) and SF- 36 for all domains except vitality. Conclusion: CE IIA added to a 12-week PPRE twice weekly was not effective in improving pain, function, and quality of life in elderly patients with knee OA.
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 60Y 至 0（—）
入选标准
- •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.
排除标准
- •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.