The Effect of Laying on of Hands on the Pain, Joint Stiffness and Functional Capacity of Older Women With Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change from baseline in pain on the visual analog scale
研究概览
简要总结
Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well as the main cause of pain and disability in older persons worldwide. The limited results of physical therapy in OA makes OA patients potential candidates for complementary therapies, such as laying on of hands. The present study aims to investigate the effect of Laying on of Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee Osteoarthritis. This is a randomized controlled trial with three allocation groups: spiritual laying on of hands ("passe espiríta" - Spiritist passe/spiritual healing) (SP), non-spiritual laying on of hands (LH) and Control Group without laying on of hands (CG). All subjects will participate in a 45-minute kinesiotherapy program. After that, groups will be directed to the 5-minute session of laying on of hands according to their groups. During the application of SP, LH and CG, the subjects will remain in a sitting position, blindfolded with dark goggles, and receive the following verbal command: "Relax and calm your mind." The intervention will happen twice a week for eight weeks and a blinded physical therapist will assess the pre and post scores of pain, functionality, joint stiffness (through WOMAC and visual analogic scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality (FACIT Sp12) and quality of life (WHOQOL-Bref), among other secondary outcomes.
详细描述
Osteoarthritis (OA) is the most common form of chronic degenerative joint disease, as well as the main cause of pain and disability in older persons worldwide. The limited results of the medical and physical therapy approach in the OA treatment make patients with such disorder into possible candidates for complementary and alternative therapies (CAT) aiming to obtain a relieve in their symptoms. Given the importance of providing alternative scientific evidence-based, painless and low cost treatments, it is necessary to carry out studies in order to investigate the impact of CAT in culturally accepted contexts, such as laying on of hands with spiritual or non-spiritual contexts. The present study aims to investigate the effect of Laying on of Hands on the Pain, Joint Stiffness and Functional Capacity of Elderly Women With Knee Osteoarthritis. This is a randomized controlled trial with three allocation groups: spiritual laying on of hands ("passe espiríta" - Spiritist passe/spiritual healing) (SP), non-spiritual laying on of hands (LH) and Control Group without laying on of hands (CG). All subjects will participate in a 45-minute kinesiotherapy program. After that, groups will be directed to the 5-minute session of laying on of hands according to their groups. During the application of SP, LH and CG, the subjects will remain in a sitting position, blindfolded with dark goggles, and receive the following verbal command: "Relax and calm your mind." The intervention will happen twice a week for eight weeks and a blinded physical therapist will assess the pre and post scores of pain, functionality, joint stiffness (through WOMAC and visual analogic scale), anxiety and depression (HADS), religiosity (DUREL) and spirituality (FACIT Sp12) and quality of life (WHOQOL-Bref), among other secondary outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically and radiographically diagnosed with OA in both knees, according to the criteria set by the American College of Rheumatology
- •Knee OA grade II or III, according to the criteria by Kellgren and Lawrence
- •Moderate to very severe pain, according to the Western Ontario and McMaster Universities (WOMAC) pain subscale) (score between 10 and 20)
- •Using stable doses of analgesics and NSAIDs during the intervention;
- •Do not perform physical therapy or other complementary therapies with laying on of hands different from those proposed in the current study;
- •Being able to travel to the rehabilitation site;
- •Being able to read, understand and speak Portuguese;
- •Preserved cognition
排除标准
- •Having made use of oral or intra-articular corticosteroids for at least 3 months before the intervention;
- •Having made use of intra-articular hyaluronate for at least three months before the intervention;
- •Having full or partial prosthetic hips and/or knees;
- •Presenting neurological diseases or other rheumatic diseases;
- •Presenting medical contraindications to perform light to moderate physical activity;
- •Being absent for two consecutive or three non-consecutive times.
结局指标
主要结局
Change from baseline in pain on the visual analog scale
时间窗: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in joint stiffness on the WOMAC scale
时间窗: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in functional capacity on the WOMAC scale
时间窗: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
Change from baseline in pain on the WOMAC scale
时间窗: At the beginning, after 8 weeks (end of intervention) and after 16 weeks.
次要结局
- Changes in depressive and anxiety symptoms on the HADS scale(At the beginning, after 8 weeks (end of intervention) and after 16 weeks.)
- Change from baseline in spirituality on the FACIT Sp12(At the beginning, after 8 weeks (end of intervention) and after 16 weeks.)
- Changes in Quality of life on the WHOQOL-Bref scale(At the beginning, after 8 weeks (end of intervention) and after 16 weeks.)
- Change from baseline in mobility through the "Timed Up and Go" test(At the beginning, after 8 weeks (end of intervention) and after 16 weeks.)
研究者
Giancarlo Lucchetti
MD, PhD
Federal University of Juiz de Fora