Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain: Protocol for a Sham-controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Disability - ODI
研究概览
简要总结
Introduction: Currently, clinical practice guidelines recommend exercise as a first-line approach to the treatment of chronic low back pain (LBP). On the other hand, passive techniques such as cupping therapy have gained space in the management of this population, however, important gaps regarding the combination of cupping therapy with active exercises in individuals with nonspecific chronic low back pain are still present in the literature. In this context, this protocol describes a sham-controlled, randomized and blinded study that aims to evaluate the additional effects of cupping therapy in association with McKenzie method exercises on pain and functional outcomes of individuals with nonspecific chronic low back pain. Methods: 108 individuals with nonspecific and localized chronic low back pain in the age group of 18 to 59 years will be recruited and evaluated, regarding the inclusion and exclusion criteria. Subsequently, they will be randomized to one of 2 groups: intervention group, in which they will be submitted to the McKenzie method intervention and later the addition of the dry suction cup; and sham group, in which, after the intervention of the McKenzie method, the application of the sham cup will be added.
详细描述
The individuals will be classified and treated according to the McKenzie method (MDT) and then they will receive the application of cups in parallel to the vertebrae from L1 to L5, bilaterally. Interventions will be carried out twice a week for eight weeks. Volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), with 4 weeks of intervention (T4) and with 8 weeks of intervention (T8)
The individuals will be classified and treated according to the McKenzie method and then they will receive the application of cups in parallel to the vertebrae from L1 to L5, bilaterally. Interventions will be carried out twice a week for eight weeks. Volunteers will be evaluated before treatment (T0), immediately after the first intervention (T1), with 4 weeks of intervention (T4) and with 8 weeks of intervention (T8). The primary outcome will be physical function, functionality (Timed Up and Go test), while the secondary outcomes will be pain intensity (Numerical Pain Scale), lumbar range of motion (finger to floor test), patient expectation and patient perception (Global Perceived Effect Scale).
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
All assessments will be carried out by researcher A who will not be involved with the interventions and will remain blind to the identification of groups.
Each participant will remain identified by numbers and not names. Participants will be informed about the aim of the study to assess the additional effect of two different cupping techniques, the classic and the sham, in association with active exercise. In order not to compromise the blinding of the study, all participants will undergo the same assessment before the interventions. Intervention times will be differentiated so that there is no contact between the groups and possible exchanges of information. Data collected during participant assessments will not be revealed to the researchers responsible for the interventions.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals, male and female, 18 to 59 years, non-obese, with non-specific localized LBP for more than 3 months;
- •Report pain intensity between 3 and 8 according to the numerical pain scale;
排除标准
- •Have previously performed cupping therapy in some body segment;
- •Present neurological, vestibular, visual or auditory deficits that make assessments impossible;
- •Being in the gestational period;
- •Having severe spinal disease (including fractures, tumour, inflammatory diseases, or tumours);
- •Have undergone previous spinal surgery;
- •Present with radiating or sacroiliac back pain; another rheumatic disease such as fibromyalgia,or ankylosing spondylitis.
结局指标
主要结局
Change in Disability - ODI
时间窗: baseline and 8 weeks after
The Oswestry Disability Index (ODI) questionnaire will be used to analyze disability in people with low back pain.This instrument contains 10 items that assess the impact of low back pain on various functional activities. Values range from 0 to 5, with the highest value indicating greater disability. The final result is the sum of all items. The validated version in Portuguese is used.
次要结局
- Change in Functional test - Timed Up and Go (TUG)(baseline and 8 weeks after)
- Change Numerical Pain Scale - NPS(baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention)
- Change in participant perception(baseline and 8 weeks after)
- Change in participant expectation(baseline)
- Change in Trunk range of motion - Range of motion (ROM)(baseline, immediately after 1 intervention, 4 and 8 weeks after the intervention)
研究者
Marcelo Cardoso de Souza, PT, PhD.
Adjunct Professor
Universidade Federal do Rio Grande do Norte