Disability and Pain in Men and Women With Chronic Low Back Pain and Pronated Foot Treated With Custom-made Foot Orthoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)
研究概览
简要总结
Purpose: excessive foot pronation has been reported as being related to chronic low back symptoms. Compensating custom-made foot orthotics treatment has not been entirely explored as an effective therapy for chronic low back pain (CLBP). This study aims to observe the effects of custom made foot orthoses, in subjects with foot pronation suffering from CLBP.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men adults up to 65 years old,
- •presence of Chronic Low Back Pain
- •Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6
排除标准
- •Serious illness.
- •Current participation in another research study.
- •Pregnancy.
- •Previous back or foot surgery
- •Current treatment of a foot or back pathology
- •Leg length discrepancy > 5 mm
研究组 & 干预措施
Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene)
Individually manufactured plantar orthosis, moulded to each patient's pronated foot using 3 mm polyurethane foam laminated with 3 mm polypropylene, designed to control excessive pronation and thus potentially alleviate non-specific chronic low back pain.
干预措施: Foot Orthoses (Device)
Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam)
Flat insole made of 3 mm polyurethane foam without corrective elements, used as a placebo comparator to the custom-made orthosis in the management of non-specific chronic low back pain.
干预措施: Foot Orthoses (Device)
结局指标
主要结局
Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)
时间窗: Baseline and 4 weeks after intervention
The RMDQ is a 24-item self-reported questionnaire designed to assess physical disability due to low back pain. Scores range from 0 to 24, with higher scores indicating greater disability.
次要结局
- Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10)(Baseline and 4 weeks)
- Change in foot posture measured by the Foot Posture Index (FPI)(Baseline and 4 weeks)
研究者
MANUEL PABON CARRASCO
Principal Investigator, Assistant Professor, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville
University of Seville