The Role of Balneotherapy in Older Adults With Chronic Low Back Pain: a Biopsychosocial Approach at São Pedro do Sul Thermal Baths
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Center for Epidemiologic Studies Depression Scale
研究概览
简要总结
The effectiveness of balneotherapy in relieving chronic low back pain has been scientifically proven. This project aims to study in what extent a Balneotherapy program in São Pedro do Sul Thermal Baths influences chronic low back pain of individuals aged 65 and above, and in what order of magnitude it happens, on which domains (functional, psychological, biophysical and socioeconomic) and it's repercussions. For that, the investigators intended to carry out a project subdivided into two tasks. The first, and the most complex, with a holistic approach, will be carried out by a randomized controlled study (RCT) with focus on the various biopsychosocial domains of patients with chronic lumbar pain. Concerning the second task, another RCT will be carried out aiming for statistically significant changes in the lumbar thermographic maps before and after treatment, as well as the theoretical framework of all the findings.
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)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 65 and over
- •Low back pain with or without irradiation to the lower limbs with more than 3 months of evolution
- •Imaging exam of the lumbar spine that excludes neoplastic pathology or severe structural misalignments
- •Availability to carry out a 14-day treatment plan
排除标准
- •Can't read and write
- •History of fracture, surgery, infection or neoplasm in the spine
- •Scoliosis with a cobb angle >20
- •Lower limb muscle strength or vesico-sphincter changes
- •Fever, history of recent violent trauma, unexplained weight loss, night sweats, or persistent night pain
- •Others: unstable angina pectoris, poorly controlled hypertension, cardiac decompensation, respiratory failure, endocrine disorder, acute febrile condition, skin infections, fecal or urinary incontinence and psychosis or decompensated neurosis
结局指标
主要结局
Center for Epidemiologic Studies Depression Scale
时间窗: two weeks
Depression assessment; From "0" (minimum - better) to "60" (maximum - worse)
Oswestry Disability Index, version 2.0
时间窗: two weeks
Functional assessment; From "0%" (minimum - better) to "100%" (maximum - worse)
Satisfaction with life scale - 5 items version
时间窗: two weeks
Satisfaction with life scale assessment; From "5" (minimum - worse) to "35" (maximum - better)
Numerical Rating Scale
时间窗: two weeks
Pain assessment; From "0" (minimum - better) to "10" (maximum - worse)
The Short Form-36
时间窗: two weeks
Quality of life assessment; From "0" (minimum - worse) to "100" (maximum - better)
International Physical Activity Questionnaire - short version
时间窗: two weeks
Physical activity assessment; low values (worse) vs high values (better)
Fatigue Assessment Scale
时间窗: two weeks
Fatigue assessment; From "10" (minimum - better) to "50" (maximum - worse)
Dolorimeter
时间窗: two weeks
Pain assessment; low values (worse) vs high values (better)
次要结局
未报告次要终点