Effectiveness of Education to Keep the Abdomen Relaxed Versus Contracted During Pilates Exercises in Patients With Primary Chronic Low Back Pain: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Disability related
研究概览
简要总结
This study aims to investigate the effectiveness of education to keep the abdomen relaxed versus contracted during Pilates exercises in patients with primary chronic low back pain.
Participants will be randomised into two groups that will be treated with Pilates exercises for 12 weeks. The control group will receive guidance on the specific activation of the center of strength (the powerhouse), while the experimental group will receive guidance to perform the exercises in a relaxed and smooth way. Primary outcomes will be pain intensity and disability 12 weeks post randomisation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 years old;
- •Low back pain for more than 3 months;
- •Disability level ≥ 4 points on the Roland-Morris Disability Questionnaire (RMDQ);
- •Ability to move independently with or without assistance;
- •Ability to understand Portuguese enough to be able to fill in the questionnaires.
排除标准
- •The main area of pain other than the lumbar spine (eg, nerve root compression or herniated disc with radicular pain, lateral or central stenosis);
- •Surgery performed on the lumbar spine.
- •Surgery performed on the lower limbs, or abdominal region less than 6 months ago;
- •Performing an invasive procedure for pain relief (eg, epidural injection, rhizotomy) in the last 3 months;
- •Diagnosis of inflammatory rheumatologic diseases, progressive neurological disease, or viral diseases as the primary cause of pain;
- •Scoliosis as the primary cause of pain;
- •Unstable heart conditions;
- •Presence of red flags such as malignancy/cancer, acute trauma (less than 6 months), infection, spinal cord/cauda equina compression.
结局指标
主要结局
Disability related
时间窗: 12 weeks post randomisation
Disability will be obtained through self-report by the Brazilian version of the Roland-Morris Disability Questionnaire (RMDQ) (Nusbaum et al., 2001), which has 24 statements involving activities and pain situations, to which the patient is instructed to answer "yes" only to those described in the assessment day, and each answer corresponds to one point.
Pain intensity
时间窗: 12 weeks post randomisation
Pain intensity will be obtained through self-report by the Brazilian version of the 11-point Numerical Pain Scale (NPS) (Costa et al., 2008; Vigotsky et al., 2021), which varies between 0 and 10 points, where 0 is "no pain" and 10 is "the worst pain imaginable" where individuals should report pain intensity based on the last 7 days.
次要结局
- Specific functionality(12 weeks post randomisation)
- Perception of global improvement(12 weeks post randomisation)