Comparison of the Effects of Connective Tissue Massage and Classical Massage Methods on Pain, Flexibility, Disability and Autonomic Responses in Chronic Mechanical Back Pain, Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in autonomic function (blood pressure) compared with baseline and last measurement
研究概览
简要总结
As a randomized study, this study aimed to investigate the effects of classical massage and connective tissue massage on pain, flexibility, disability, quality of life and autonomic responses in patients with chronic mechanical low back pain. The primary evaluation parameter of the study is autonomic function and the secondary evaluation parameter is pain. The participants will be treated accompanied with same physiotherapist along four weeks and five days in a week. A six-week follow-up will be performed to see how long the effect of the treatment continues.
详细描述
Mechanical low back pain is defined as a condition that causes tension, pain, or stiffness in the lumbar region where it is not possible to define a specific cause (eg infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome). Low back pain has become one of the biggest problems for public health systems in the Western world in the second half of the 20th century and continues to be a major health problem worldwide today. In a review based on studies on low back pain in 54 countries, the prevalence of low back pain was found to be 18.3%. As a result of researches made in Turkey in the 18-24 age range prevalence of women was 28.9%, in men was 18.1%, with advanced age over the age of 55 rate increasing further, it raise 48.1% in women and 31.5% in men. As shown in the researches, low back pain is seen more frequently in the age of late 20s and in women.
Disc degeneration, nociceptive factors, tumor necrosis factor α and smoking have been reported to be reason in mechanical low back pain. Although there are widely used clinical tests for pathologies arising from lumbar structures (discogenic low back pain, facet joint pain, sacroiliac joint pain), these tests cannot be used to diagnose non-specific mechanical low back pain.
The affect of chronic pain on individuals is quite different. Pain creates problems in the life of the individual starting from minimal to high level of disability and consequently severely restricts their participation in work and social life and their roles in the family. Medicines used to reduce pain are addictive after a while. Therefore, researchers emphasized the need for more emphasis on non-pharmacological treatment approaches in the management of persistent low back pain. Among these approaches, manual treatment, exercise, massage, and acupuncture methods are included in the treatment guidelines for mechanical low back pain.
No method of treatment of low back pain can produce a permanent improvement. However, there are several approaches that reduce pain and disability. Among these, massage is considered as a safe treatment method due to its low side effects and risk. Massage has been shown to be effective in some types of headaches, post-exercise muscle pain, and mechanical neck pain, but is also reported to cause relaxation and psychological relaxation. Classical massage (CM) is thought to improve the physiological and clinical outcomes by providing symptomatic reduction in pain through physical and mental relief and by increasing pain threshold by endorphin release. It is also suggested that CM has some effects on the nervous system. Massage applications cause repetitive sensory stimulations to occur and changes in neuronal circuits, such as blood pressure, cause altered activity in the autonomic nervous system.
Connective tissue remodeling has been reported in patients with chronic low back pain due to emotional, behavioral and motor dysfunction. Increased stress due to excessive use, repetitive motion and / or hypermobility, and reduced stress due to immobilization or hypomobility, cause changes in the connective tissue. Chronic, local increase in stress can lead to micro-injury and inflammation, while the absence of stress in the tissue leads to connective tissue atrophy, architectural disorder, fibroses, adhesions and contractures.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between 20-60 years of age
- •Low back pain for more than 12 weeks
- •Lack of neurological problems caused by lumbar region
- •Not to be included in physiotherapy and rehabilitation program in the last 6 months
排除标准
- •Having ankylosing spondylitis
- •Pain and / or numbness in the hip and lower extremities
- •Previous trauma or surgery in lumbar region
- •Presence of congenital malalignment in the vertebral column
- •Malignancy
- •Lower limb inequality over one cm
- •Pregnancy
- •Blood pressure difference of more than 10 mmHg between two arms
结局指标
主要结局
Changes in autonomic function (blood pressure) compared with baseline and last measurement
时间窗: Measurements will be made at baseline and 4th week (last assessment). It takes about two minutes
Blood pressure will be measured with manual sphygmomanometer (mmHg).
Changes in autonomic function (pulse) compared with baseline and last measurement
时间窗: Measurements will be made at baseline and 4th week (last assessment). It takes about one minute.
Pulse will be measured with pulse oximeter (pulse/min).
Changes in autonomic function (temperature) compared with baseline and last measurement
时间窗: Measurements will be made at baseline and 4th week (last assessment). It takes about five minutes
Local temperature and peripheral temperature measurements will be made with laser-marked heat meter (°C).
Changes in low back pain compared with baseline and last measurement
时间窗: Measurements will be made at baseline and 4th week (last assessment). It takes about one minute.
Low back pain will be measured with using Visual Analog Scale (cm).
次要结局
- Changes in flexibility (lumbar lateral flexion test) compared to baseline with baseline and last measurement(Measurements will be made at baseline and 4th week (last assessment). It takes about five minutes.)
- Changes in disability compared to baseline with baseline and last measurement(Measurements will be made at baseline and 4th week (last assessment). It takes about three minutes.)
- Changes in quality of life compared to baseline with baseline and last measurement(Measurements will be made at baseline and 4th week (last assessment). It takes about three minutes.)
- Changes in autonomic function (pulse) at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about one minute.)
- Changes in autonomic function (blood pressure) at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about two minutes)
- Changes in autonomic function (temperature) at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about five minutes)
- Changes in low back pain at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about one minute.)
- Changes in disability at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about three minutes.)
- Changes in flexibility (sit and reach) compared to baseline with baseline and last measurement(Measurements will be made at baseline and 4th week (last assessment). It takes about two minutes.)
- Changes in quality of life at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about three minutes.)
- Changes in flexibility (lumbar lateral flexion) at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about two minutes.)
- Changes in flexibility (sit and reach) at six weeks after the end of the treatment(Measurements will be made at six weeks after the end of the treatment. It takes about two minutes.)
