The Effects of Dry Cupping on Pain, Function and Quality of Life of Women With Knee Osteoarthritis: Protocol for a Placebo-controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change from Numerical Rating Scale (NRS)
研究概览
简要总结
Introduction: Knee osteoarthritis (KOA) is the biggest cause of pain and disability worldwide. As a non-pharmacological approach, ventosatherapia has been used to control pain, improve function and quality of life. However, there is a lack of high-quality scientific evidence regarding its effects on this condition. Objective: To evaluate the effects of dry cupping on pain, function and quality of life in women with KOA. Methods: This is a randomized, blinded placebo-controlled protocol. 62 women diagnosed with KOA will be recruited, based on the clinical criteria of the American College of Rheumatology, who will be randomly divided into two groups (31 per group): dry cupping and dry cupping sham.
详细描述
The intervention will be carried out for 15 minutes, twice a week, for 6 consecutive weeks, totaling 12 sessions. Both groups will be evaluated in 4 moments: before the intervention (T0), after 3 weeks of interventions (T3), at the end of the protocol (T6) and 4 weeks after the end of the interventions (follow-up - T10). The analyzed outcomes will be: Primary - pain (numerical pain scale); Secondary - Physical function (WOMAC; tests of going up / down stairs, brisk walking in 40 m and sitting / rising from a chair in 30 s), quality of life (SF-36) and global perception of the effect
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 (Participant, Outcomes Assessor)
盲法说明
To avoid any type of selection bias, the confidential allocation method will be through opaque envelopes, sealed and numbered consecutively. The randomization process will be carried out by an independent researcher who will not be involved in other study procedures. The group in which the participant will be allocated will be revealed to the researcher responsible for the consultations prior to the first intervention.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with KOA based on ACR clinical criteria;
- •Knee pain intensity between 3 and 8, according to the Numerical Pain Scale (END);
- •BMI less than 35 kg / m2.
排除标准
- •Having undergone physical therapy treatment for the knee in the 3 months prior to the project;
- •Be engaged in> 45 minutes / week in accumulated physical activity of at least moderate intensity;
- •To have been submitted to the application and / or intervention with the wind therapy previously.
- •Have used corticosteroid infiltration in the knee in the last 6 months;
- •Present any medical restrictions that make it impossible for them to participate in the proposed assessments and interventions (cardiorespiratory, neurological and / or musculoskeletal changes);
- •Presenting a diagnosis of fibromyalgia, rheumatoid arthritis or some systemic inflammatory arthritis;
- •Presenting a ligament or meniscal injury diagnosed clinically or with a positive result in the Apley tests or anterior / posterior drawer;
- •Have had previous surgery on the ankle, knee or hip;
- •Present a clinical diagnosis of some dementia or inability to answer the questionnaires related to the study;
- •Present any contraindications for the use of ventosatherapia (skin lesion in the region where it will be applied, cancer, kidney failure, liver and heart failure, pacemaker, pregnancy);
- •Having uncontrolled diabetes and hypertension;
- •Have a trip scheduled for the two months following inclusion in the survey.
结局指标
主要结局
Change from Numerical Rating Scale (NRS)
时间窗: baseline, 3 ,6 and 10 weeks after.
Subjective measure in which individuals rate their pain on an eleven-point numerical scale. Such scale will be positioned in front of the participant and will vary from 0 to 10 points, with 0 being the complete absence of pain and 10 being the worst pain imaginable by the individual
次要结局
- Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 3 ,6 and 10 weeks after.)
- Change from 30-second Chair Stand Test(baseline, 6 and 10 weeks after.)
- Change from 8-step Stair Climb Test(baseline, 6 and 10 weeks after.)
- Change from 40m Fast Paced Walk Test(baseline, 6 and 10 weeks after.)
- Change from Short-Form 36 quality of life(baseline, 6 and 10 weeks after.)
- Change from Global Perceived Effect(baseline, 3, 6 and 10 weeks after.)
- Change from use of analgesics and anti-inflammatories(baseline, 3, 6 and 10 weeks after)
- Change from expectation with treatment after the intervention protocol .(baseline and 10 weeks after)
研究者
Marcelo Cardoso de Souza, PT, PhD.
Adjunct Professor
Universidade Federal do Rio Grande do Norte