Short, Medium and Long Term Effects of a Protocol of Hip Flexor Stretching, Exercise and Pain Managment Education, Function and Disability in Patients With Chronic, Mechanical, Non-specific Low Back Pain. Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of a stretching, exercise and education protocol versus usual care in improving pain, function and disability in patients with non-specific mechanical chronic low back pain (CLBP). The research hypothesis is: A combination of hip flexors stretching, exercise and education is more effective than usual care to improve pain, function and disability in patients with CLBP.
Participants will be randomly allocated in one of the two treatment groups. Pain, function and disability will be assessed before starting treatment, after the end of the treatment and one month , three months and one year after the end of the treatment.
详细描述
Study design: the study is a randomized controlled study that will be conducted in a physiotherapy center in Poland. Potential subjects will be identified in public and private health services by a medicine doctor who will be responsible for screening subjects for eligibility and enrolling into the study.
Men and Women between 18 and 75 years old that will fulfill the criteria and will sign the informed consent will be randomly assigned to one of the two treatment groups. Randomization will be 1:1 ratio and the method to generate random allocation will be a random computer generated numbers table.
Evaluator, outcome assessor, will be blinded to the participant's group assignment.
The study has been approved by the research ethics committee of Wroclaw University of Health Sciences and Sports. The study will be conducted in accordance with ethical principles of the declaration of Helsinki (75th World Medical Association General Assembly , Helsinki, Finland, October 2024)
Treatment Groups:
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Medical diagnosis of chronic, mechanical, non-specific pain in the lumbar spine (M54, M51) - chronic low back pain.
- •Obtaining written consent to conduct research
- •Must be able to swallow tablets
排除标准
- •Pregnancy
- •Pacemaker
- •Active cancer
- •To consent to conduct research
- •Difficulty communicating
- •The presence of a metal plate in the head and metal screws in the body
- •Condition after operations in the area of the lumbar spine
- •Condition after fractures in the lumbar spine
- •Contraindications to manual therapy or exercise
- •Has participated in a lumbar spine exercise or manual therapy program in the last three months
- •Present clear signs of having suffered a significant lumbar injury
- •Inability to maintain standing or a supine or prone position
- •No possibility to perform the stretching of hip flexors
研究组 & 干预措施
Experimental group
Participants will receive a protocol of hip flexors stretching, exercise and education for chronic low back pain added to the standard of care in the Polish public health services prescribed by the medicine doctor.
干预措施: Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling) (Other)
Experimental group
Participants will receive a protocol of hip flexors stretching, exercise and education for chronic low back pain added to the standard of care in the Polish public health services prescribed by the medicine doctor.
干预措施: Medical treatment. (Drug)
Control group
Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor.
干预措施: Medical treatment. (Drug)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Numeric Pain Rating Scale (NPRS) The NPRS will be used to ask the patient about the level of pain that he/she feels considering from 0 to 10, where 0 represents the absence of pain and 10 represents the most intense pain, used to measure the pain experienced by the patient. The participant will answer the NPRS, responding to the average, maximum and minimum pain experienced throughout its duration.
次要结局
- Lumbar Range of Motion(Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.)
- ROM in Thomas test(Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment)
- Clinical Measure of extension.(Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.)
- Anatomical distribution of pain(Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment)
- ROM in Straight Leg Raise Test(Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.)
- Quality of Life level(Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment)
- Kinesiophobia(Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment)
- Degree of Functional Disability(Baseline,to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment)
- Physical activity level(Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment)
- Body composition analysis(Baseline)
研究者
Aleksander Kucza
MSc
Wroclaw University of Health and Sport Sciences