The Effect of Elastic Bandage Compression on Pain and Function in Individuals With Knee Osteoarthritis - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline - Visual Analog Scale (VAS)
研究概览
简要总结
Introduction and Purpose: Compression is a tactile stimulus that can reduce the perception of pain by stimulating tactile skin receptors and the speed of nerve conduction. It is highly associated with cryotherapy and other non-pharmacological physical agents without musculoskeletal pain control. However, there is still a lack of evidence on its possible effects on the modulation of this type of pain. This study will evaluate the effect of compression by elastic bandages, on pain and on the function of belonging with knee osteoarthritis (KO). Methodology: A randomized, blinded controlled clinical trial will be conducted. Individuals with KO (n = 90; both sexes; between 40 and 75 years old), will be allocated into three groups (n = 30 / group): Compression (submitted to compression by elastic bandage on the affected knee, 20 min, in 4 days consecutive); Sham (submitted to the same protocol with elastic bandage, but without compression); and Control (waiting list, without intervention). All will be taken one day before the start and one day after the last intervention. They will also be adopted in the 12th and 24th weeks after the intervention. The main outcome will be the pain intensity (Visual Analogue Scale). The Western Ontario & McMaster Universities Osteoarthritis (WOMAC) physical function questionnaire, physical function tests (step test, sit and stand test in 30s, 40m accelerated walk test), and the perception scale global change (GRC). Data analysis: SPSS 24.0 software will be used for descriptive analysis and performance of Kolmogorov-Smirnov tests, two-way ANOVA and multiple comparison tests. A 95% confidence level and a 5% significance level will be adopted.
详细描述
Study design: The study consists of a randomized controlled clinical trial that meets the guidelines recommended by CONSORT (Consolidated Standards of Reporting Trials) for non-pharmacological studies TIDieR (Template for Intervention Description and Replication) and OARSI recommendations for clinical trials with patients with knee osteoarthritis . The procedures will always be carried out at the same times for each volunteer, during the intervention and evaluation days, so that the same time interval between interventions and evaluations is respected.
The evaluations will be carried out by a "blind" evaluator with no information about the identification of the group to which the volunteer belongs. The evaluator will also be trained to maintain balance in discussions and questions raised by individuals regarding the research project and the interventions or evaluations used.
The screening, evaluation and intervention will be carried out at the School Health Unit - USE, Federal University of São Carlos (UFSCar), São Carlos. It is a non-probabilistic sampling study, for convenience and intentional. Volunteers will be recruited from public announcements and waiting lists from local and regional physiotherapy, rehabilitation, orthopedics and rheumatology outpatient clinics, as well as from an existing list of volunteers diagnosed with knee osteoarthritis, available in our laboratory.
Participants: 90 individuals will participate in the study, of both sexes, aged between 40 and 75 years, diagnosed with KO according to the clinical and radiographic criteria of the American College of Rheumatology. The individuals will perform a radiographic examination of both knees, with lateral, anteroposterior, and axial views. Radiographic exams will be performed at the University Hospital, UFSCar. The screening of volunteers will be carried out by a physiotherapist specialized in the subject and experienced in the evaluation of individuals with knee osteoarthritis.
Ethical aspects: The project was initially submitted to the Ethics and Research Committee involving human beings (Plataforma Brasil), approved under Opinion Number: 3.955.692, and submitted to the registration of clinical trials (www.clinicaltrials.gov). Then, the study activities will be carried out. Volunteers will receive a verbal and written explanation of the objectives and methodology of the study, and those who agree to participate will sign an informed consent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The evaluations will be carried out by a "blind" evaluator with no information about the identification of the group to which the volunteer belongs.
After the completion of the collections, the data will appear by a "blind" biostatistician, with no information on the identification of the groups.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of knee osteoarthritis according to the clinical and radiographic criteria of the American College of Rheumatology: signs of osteoarthritis in at least one of the compartments of the knee joint (tibiofemoral and / or in the patellofemoral joint); grade 2 or 3, according to Kellgren & Lawrence criteria in the radiographic examination;
- •Minimum score of 04 cm on the Visual Analogue Scale (EVA, total of 10 cm);
- •Accept and sign the informed consent form.
排除标准
- •Regular practice of moderate or intense physical activity for more than 45 minutes a week;
- •Having started physical activity or undergone any physical therapy treatment in the previous 3 months;
- •Use of corticosteroid infiltration in the knee (previous 6 months);
- •Performing previous surgery on the knee or hip;
- •Presence of some clinical restriction that makes it impossible for them to participate in the proposed evaluations or interventions (cardiorespiratory, neurological, musculoskeletal, vascular changes, and / or the presence of skin lesions when applying the bandage).
结局指标
主要结局
Change from baseline - Visual Analog Scale (VAS)
时间窗: Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.
The scale will be made available visually to the individual so that he can classify the intensity of the average pain relative to the last week, and also before and after the performance of each functional physical test. The scale will vary from 0 to 10 cm, with 0 being the complete absence of pain, and 10 being the maximum pain intensity reported by the individual. The 1.75cm reduction will be considered an MDCI.
Change from baseline WOMAC (Western Ontario e o McMaster Universities Osteoarthritis Index) - Pain scale
时间窗: Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.
Self-report questionnaire, designed to assess problems experienced by individuals with lower limb OA, in the last 72 hours. The volunteer will be asked to answer 24 questions, which comprise three domains: pain, stiffness and physical function. The scores for the items are expressed using the Likert scale, classified as: none = 0, low = 25, moderate = 50, severe = 75 and very severe = 100. Higher scores indicate higher levels of pain, stiffness and physical dysfunction . The reduction of 8.74 points in the pain domain, from the baseline, will be considered an MDCI.
次要结局
- Step test(Baseline, immediately after intervention and follow up evaluations of 12 and 24 weeks.)
- 40 meter accelerated walk test (4x10m)(Baseline, immediately after intervention and follow up evaluations of 12 and 24 weeks.)
- Change from baseline WOMAC (Western Ontario e o McMaster Universities Osteoarthritis Index) - stiffness and physical dysfunction scales(Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.)
- Global rating of change - GRC scale(Immediately after intervention and follow up of 12 and 24 weeks.)
- Sit and stand test - 30 seconds(Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.)
研究者
Angélica Viana Ferrari
Principal Investigator (PT)
Universidade Federal de Sao Carlos