Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Short-Form Health Survey-36.
研究概览
简要总结
A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- •18-65 years of age.
- •With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS).
排除标准
- •History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance.
- •Missing more than two Back School sessions.
- •Not being able to attend the measurement sessions.
研究组 & 干预措施
Control
They will continue with their usual lifestyle.
Aquatic program based on the back school
Participants will undertake a back school-based program. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports center. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totaling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus (centered on trunk exercises) and the other two will have a theoretical focus (providing education on pain and risk factors for low back pain).
干预措施: Aquatic program based on the back school (Behavioral)
结局指标
主要结局
Short-Form Health Survey-36.
时间窗: Through study completion, an average of 2 months.
Short-Form Health Survey was used to measure quality of life.The Short-Form Health Survey-36 explores people's physical and mental health. It consists of 36 items that assessed eight dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores ranged from 0 (worst health status) to 100 (best health status).
Tampa Scale Of Kinesiophobia.
时间窗: Through study completion, an average of 2 months.
This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia.
Roland Morris Disability Questionnaire.
时间窗: Through study completion, an average of 2 months.
The Roland Morris Disability Questionnaire Scoring is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total Roland Morris Disability Questionnaire score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.
Visual Analogue Scale.
时间窗: Through study completion, an average of 2 months.
The visual analogue scale is a widely used tool to measure pain. The patient is asked to indicate the intensity of the pain they perceive (most commonly) along a horizontal line from 0 millimetres (minimum value) to 100 millimetres (maximum value), and this score is then measured from the left edge, the higher the value in millimetres the more pain.
次要结局
未报告次要终点
研究者
Pablo Hernandez-Lucas
Associate professor in health sciences
University of Vigo