The Effect of Core Stabilization Exercise Program Applied With Telerehabilitation Method in Virtual Reality Environment in the Treatment of Patients With Chronic Non-Specific Low Back Pain: A Single-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Oswestry Low Back Pain Disability Index
研究概览
简要总结
A total of 80 patients, aged between 20 and 60 years, diagnosed with non-specific low back pain and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2024 and June 1, 2025, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. After the patients are informed verbally and in writing about the purpose, duration and application method of the study and their consent is obtained, they will be asked to sign the "Informed Consent Form". Patient evaluation and follow-up forms will be filled out during pre-treatment and post-treatment follow-ups. After patients who meet the study inclusion criteria are included in the study, they will be numbered according to the order of application and then randomly assigned to the intervention group or control group by a computer program into 2 groups.
In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks.
The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 20 and 60 years of age Non-specific low back pain lasting more than 3 months (VAS > 2) No neurological deficits such as abnormal sensation, loss of muscle strength, or loss of reflexes in the lower extremity No indication for surgery Able to attend treatment 3 days a week for 8 weeks
排除标准
- •Participating in a physical therapy or exercise program in the last 3 months Previous surgery, dislocation, or fracture in the lumbar region Rheumatic / autoimmune disease Serious cardiovascular disease, progressive neurological deficit, severe osteoporosis, or metabolic diseases Having a systemic disease that can cause back pain Pregnancy or lactation Uncontrolled hypertension Having problems perceiving verbal commands Not having internet access Not having equipment to make video calls at home Not having a device at home to use the application
研究组 & 干预措施
Telerehabilitation Group
干预措施: Core stabilization exercise with telerehabilitation (Other)
Face-to-face rehabilitation group
干预措施: Face-to-face core stabilization exercise (Other)
结局指标
主要结局
Oswestry Low Back Pain Disability Index
时间窗: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
It is a commonly used and validated scale for measuring disability in low back pain. It consists of a total of 10 questions. Each question is scored on a scale of 0 to 5. Higher scores indicate worse symptoms or functioning.
Visuel Analog Scale
时间窗: Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)
The severity of pain before treatment is assessed using the Visual Analog Scale (VAS), a 10 cm long line with "no pain" on the left end and "unbearable pain" on the right end. The distance in centimeters between the point marked by the patient and the 0 point is measured. The average pain level before and after treatment will be evaluated using the VAS, scored between 0 and 10; 0 indicates no pain, and 10 indicates the worst possible pain.
次要结局
- Roland Morris Disability Questionnaire(Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment))
- Tampa Kinesiophobia Fatigue Scale(Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment))
- Measurement of Bilateral Lumbar Multifidus and Transversus Abdominis Muscle Thickness with Ultrasound Imaging(Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment))
- Assessment of Trunk Muscle Strength with Computerized Isokinetic Dynamometer(Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment))
研究者
Emre Öney
Medical Doctor
Istanbul University