The Effect of Orthosis and Exercise Training on Pain, Physical Function and Quality of Life in Patients With Spondylolisthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- World Health Organization Quality of Life Scale Short Form
研究概览
简要总结
In the treatment of spondylolisthesis, conservative methods are initially preferred unless severe neurological symptoms are present; surgical treatment is only performed in refractory cases lasting at least 3-6 months. Conservative treatment consists of orthotic use, activity restriction, pain control, physiotherapy and exercise. Orthotics may promote healing by restricting movement; however, there are not enough studies on this subject. Exercise is the intervention with the highest level of evidence in chronic low back pain. The efficacy of stabilisation exercises in providing positive and long-lasting effects on pain and functional disability in patients with spondylolisthesis has been demonstrated. However, studies evaluating the effect of exercise on spinal stability and radiological findings are limited. Therefore, this study aims to compare the effects of stabilization and conventional exercises with orthosis on radiographic findings, pain, physical function and quality of life.
详细描述
Treatment is initially conservative (in the absence of severe neurologic symptoms) and surgical treatment is only indicated for those who have been refractory to non-surgical options for at least 3 to 6 months. Conservative treatment usually consists of orthotics, activity restriction, pain control, physiotherapy program and exercise. It has been reported in the literature that the use of orthotics helps to restrict activities by acting as a physical barrier against provocative movements and allows sufficient immobilization to promote healing. However, there are not enough studies on this subject in the literature. Exercise is the intervention with the highest level of evidence for improving CLBP and is superior to all other interventions in terms of improving pain and function.
In the literature, it has been reported that stabilization exercises, one of the current types of exercises recommended for patients with spondylolisthesis, can reduce pain and functional disability in patients and that this effect can be maintained over a 30-month follow-up period. There are a limited number of studies investigating whether exercise therapy can objectively contribute to the improvement of structural stability and intervertebral motion in the spine, especially in patients with grade-I slippage preferably managed with non-invasive treatments, and the effect of exercise therapy on radiological findings in patients affected by spondylolisthesis. In the light of this information, it was planned to compare the effects of stabilization and conventional exercises combined with orthosis use on radiographic findings, pain level, physical function and quality of life in patients with spondylolisthesis.
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 (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
- •Individuals aged 18-65
- •Individuals without indication for surgery
- •Individuals diagnosed with grade 1-2 spondylolysis
- •Individuals without neurological deficits
- •Individuals diagnosed with radicular pain or non-specific chronic low back pain for more than 3 months
排除标准
- •Surgery recommended after diagnosis
- •History of lumbar surgery
- •Presence of rheumatic inflammatory diseases or diabetic polyneuropathy
- •Individuals with symptoms of cauda equina or ischemic heart disease
- •Presence of back pain with non-mechanical causes or non-radicular neuropathic pain
- •Having received this type of exercise therapy before
研究组 & 干预措施
Stabilization Exercise Group
Participants diagnosed with spondylolisthesis after randomization and assigned to the stabilization exercise group will be treated after being evaluated by the research therapist. In this context, the physiotherapist will structure a program consisting of a combination of recommended soft orthosis, pain control, stabilization exercises, posture training and home exercises. Soft orthosis will be applied for 10-12 hours a day for 4-6 weeks; 20 minutes of TENS and 20 minutes of Hotpack for pain control; and stabilization exercises with Stabilizer Pressure Biofeedback device. The planned stabilization exercise program will be 30-35 minutes; 15 minutes of posture training will be applied. These applications will be performed in the clinical environment 2 days a week for 10 weeks with a physiotherapist. Participants will be asked to practice the home exercise program taught in the training session 6 days a week for 12 weeks, excluding clinical applications.
干预措施: Stabilitation Exercise (Other)
Stabilization Exercise Group
Participants diagnosed with spondylolisthesis after randomization and assigned to the stabilization exercise group will be treated after being evaluated by the research therapist. In this context, the physiotherapist will structure a program consisting of a combination of recommended soft orthosis, pain control, stabilization exercises, posture training and home exercises. Soft orthosis will be applied for 10-12 hours a day for 4-6 weeks; 20 minutes of TENS and 20 minutes of Hotpack for pain control; and stabilization exercises with Stabilizer Pressure Biofeedback device. The planned stabilization exercise program will be 30-35 minutes; 15 minutes of posture training will be applied. These applications will be performed in the clinical environment 2 days a week for 10 weeks with a physiotherapist. Participants will be asked to practice the home exercise program taught in the training session 6 days a week for 12 weeks, excluding clinical applications.
干预措施: Orthosis (Other)
Conventional Exercise Group
After randomization, participants assigned to the conventional exercise group and diagnosed with spondylolisthesis will be evaluated and treated by the research therapist. In this context, the physiotherapist will structure a program consisting of a combination of the recommended soft orthosis, physiotherapy (pain control and exercise) and home exercises. The soft orthosis will be applied 10-12 hours a day for 4-6 weeks; 20 minutes of TENS and 20 minutes of Hotpack for pain control; 30-35 minutes of conventional exercise program will be applied. These applications will be performed in the clinical environment 2 days a week for 10 weeks in the presence of a physiotherapist. Participants will be asked to perform the home exercise program taught in the training session 6 days a week for 12 weeks, excluding clinical applications.
干预措施: Conventional Exercise (Other)
Conventional Exercise Group
After randomization, participants assigned to the conventional exercise group and diagnosed with spondylolisthesis will be evaluated and treated by the research therapist. In this context, the physiotherapist will structure a program consisting of a combination of the recommended soft orthosis, physiotherapy (pain control and exercise) and home exercises. The soft orthosis will be applied 10-12 hours a day for 4-6 weeks; 20 minutes of TENS and 20 minutes of Hotpack for pain control; 30-35 minutes of conventional exercise program will be applied. These applications will be performed in the clinical environment 2 days a week for 10 weeks in the presence of a physiotherapist. Participants will be asked to perform the home exercise program taught in the training session 6 days a week for 12 weeks, excluding clinical applications.
干预措施: Orthosis (Other)
Control Group
Individuals who have been diagnosed with spondylolisthesis and have not undergone the recommended treatment will be included in the control group for the study.
结局指标
主要结局
World Health Organization Quality of Life Scale Short Form
时间窗: Week 0, week 10, week 12
The scale, consists of 4 sections (physical health, psychological health, social relations and environment) and a total of 27 questions. The individual is asked to score the questions between 1-5, taking into account the last 15 days. Higher scores in the total score and subscales indicate better quality of life.
Berg Balance Scale
时间窗: Week 0, week 10, week 12
This scale is a 14-question test assessing postural control and fall risk. Each question is scored between 0-4 and the maximum score is 56. 0-20 points are defined as impaired balance / high fall risk, 21-40 points as acceptable balance / moderate fall risk, 41-56 points as good balance / low fall risk.
Joint Position Sensation
时间窗: Week 0, week 10, week 12
It will be assessed by joint position sense, which measures the patients' ability to actively reposition the lower back to their neutral position. The patient will be seated with feet on the floor, hands on the thighs, hip-knee flexed 90 degrees with the back on a hard surface and the patient will be instructed to assume a neutral lumbar spine position. The stabilizer pressure biofeedback device will be placed between the neutral spine and the hard surface and inflated to 70 mmHg. The participant will be asked to perform maximal anterior and posterior pelvic tilts 2 times in succession, waiting 5 seconds at each end point, and then return to the neutral position. The pressure difference between the initial and final measurement will be recorded.
McGill Pain Questionnaire Short Form
时间窗: Week 0, week 10, week 12
In the questionnaire, pain level is defined with 15 words consisting of 11 sensory and 4 affective words (0-3 points). The pain felt at the time of the questionnaire is measured with the VAS 6-point Likert scale (0-5). In total, pain is scored between 0-45 (no pain=0, severe pain=45).
Oswestry Disability Index
时间窗: Week 0, week 10, week 12
Disability will be assessed with the Oswestry Disability Index (ODI), which consists of 10 questions that determine functional disability for activities such as sitting, walking, personal care, standing, social life, traveling, and sleeping. Each question has 6 options and the patient is asked to choose the statement that best describes his/her condition. Each question is evaluated between 0-5 points. The question about sexual life may not be answered if it is not appropriate for the person's situation. The higher the score, the higher the level of limitation. The total score percentage varies between 0-100. In scoring, a score of 0-20% indicates minimal disability, 20-40% indicates moderate disability, 40-60% indicates severe disability, and over 60% indicates severe disability. The total score percentage is calculated as follows. "Total Score Percentage= Total Score/(5x Number of Questions Answered) x 100".
次要结局
- Tampa Kinesiophobia Scale(Week 0, week 10, week 12)
- Manual Muscle Test(Week 0, week 10, week 12)
- Pelvic Parameters(Week 0, week 12)
- Global Rating of Change(week 12)
- Use of Orthotics and Home Exercise Diary(On a weekly basis up to 3 months)
研究者
Fatma Dilge ASIK BOZDEMIR
Lecturer - PhD(c)
Medipol University