Is the Positioning of the Lumbar Spine Relevant to the Manual Treatment of the Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Changes in Disability
研究概览
简要总结
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 46 subjects of legal age with non-specific chronic low back pain will be selected and randomized into two interventions.
The first group will receive lumbar posteroanterior mobilizations with the lumbar spine in extension and the second group will receive lumbar mobilizations with neutral position of the spine. Both groups will also receive a home exercise program for the lumbar spine.
The total duration of the treatments will be 6 weeks, with pre-treatment, at 3 weeks of the treatment, post-treatment evaluations at 6 weeks, with a follow-up after 1 month and with a follow-up after 3 months.
The objective will be to evaluate which of the two interventions is more effective in addressing disability variables (main variable), pressure pain threshold, pain location, pain intensity, quality of life, quality of sleep, depression and kinesiophobia.
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 (Participant)
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
- •subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention
排除标准
- •lumbar pain related to infectious diseases
- •fractures
- •oncological processes
- •women in gestation period.
结局指标
主要结局
Changes in Disability
时间窗: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measured with the Oswestry Low Back Pain Disability Questionnaire. The interpretation of the scores of this scale varies from 0% to 100%. 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
次要结局
- Pain measured with visual analogic scale(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
- Kinesiophobia measured with the TAMPA scale of kinesiophobia(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
- Health measured with the short form health survey version II(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
- Quality of sleep measured with the Pittsburgh Sleep Quality Index(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
- Changes in Site of pain(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
- Changes in Pressure pain threshold(Baseline, 3 weeks and 6 weeks after intervention commencement)
- Changes in Medication(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
- Depression measured with Beck's Depression Inventory(Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement)
研究者
Alexander Achalandabaso
Principal Investigator
University of Jaén