Effects of SIS Therapy in Individuals With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
研究概览
简要总结
Brief Summary - buraya yapıştırın
Chronic nonspecific low back pain is a common condition that can cause pain, limitations in daily activities, and reduced quality of life. Exercise and conventional physiotherapy are commonly used to manage chronic low back pain. SIS Therapy is a physiotherapy approach intended to reduce pain and improve movement and function.
The aim of this randomized controlled trial is to investigate the effects of SIS Therapy in individuals with chronic nonspecific low back pain and to compare these effects with conventional physiotherapy.
Participants will be randomly assigned to one of two groups. The SIS Therapy group will receive SIS Therapy together with a standard exercise program consisting of lumbar stabilization and stretching exercises. The conventional physiotherapy group will receive a program consisting of heat application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and therapeutic exercise. Both groups will receive treatment twice a week for four weeks, for a total of eight sessions, and both groups will receive the same home exercise program.
Participants will be evaluated before and after the four-week treatment period. The assessments will examine changes in pain intensity, lumbar mobility, and back extensor muscle endurance.
详细描述
This study is a prospective, assessor-blinded, two-arm, parallel-group randomized controlled trial designed to investigate the effects of SIS Therapy in individuals with chronic nonspecific low back pain and to compare its effects with conventional physiotherapy.
Individuals aged 18-65 years with chronic nonspecific low back pain lasting for at least three months will be screened for eligibility. Individuals with a Visual Analog Scale (VAS) pain intensity score of 4 or higher, who are able to walk independently and who voluntarily agree to participate in the study by providing written informed consent will be included.
After enrollment, participants will be randomly allocated to one of two intervention groups in a 1:1 ratio using a computer-generated randomization sequence. Allocation concealment will be achieved using sequentially numbered, opaque, sealed envelopes prepared according to the randomization sequence by a researcher independent of the study. The researcher responsible for outcome assessments will be blinded to group allocation.
Participants allocated to the SIS Therapy group will receive SIS Therapy together with a standard exercise program consisting of lumbar stabilization and stretching exercises. Participants allocated to the conventional physiotherapy group will receive a conventional physiotherapy program consisting of heat application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and therapeutic exercise. Both groups will receive treatment twice per week for four weeks, resulting in a total of eight treatment sessions. In addition, the same home exercise program will be provided to participants in both groups.
Outcome assessments will be performed at baseline before the intervention and after completion of the four-week intervention period by the same assessor under standardized conditions.
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
- •Inclusion Criteria:
- •Aged between 18 and 65 years Having chronic nonspecific low back pain for at least 3 months Having a pain intensity of 4 or higher on the Visual Analog Scale (VAS) Being able to walk independently Volunteering to participate in the study and providing written informed consent
排除标准
- •History of lumbar spine surgery Severe neurological deficit or radiculopathy associated with disc herniation Presence of vertebral fracture, tumor, infection, or inflammatory rheumatic disease Pregnancy History of malignancy Having received physiotherapy for the lumbar region within the previous 3 months Cognitive or communication problems that may prevent compliance with the assessments
研究组 & 干预措施
SIS Therapy Group
Participants in this group will receive SIS Therapy in addition to a standard exercise program consisting of lumbar stabilization and stretching exercises. The intervention will be administered twice weekly for four weeks, for a total of eight treatment sessions. Participants will also receive a home exercise program.
干预措施: SIS Therapy (Other)
Conventional Physiotherapy Group
Participants in this group will receive conventional physiotherapy consisting of heat application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and therapeutic exercise. The intervention will be administered twice weekly for four weeks, for a total of eight treatment sessions. Participants will also receive the same home exercise program provided to the SIS Therapy group.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
时间窗: Baseline and immediately after the 4-week intervention
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their current low back pain on a 10-cm horizontal scale ranging from 0 (no pain) to 10 (unbearable pain). Higher scores indicate greater pain intensity. Change in VAS score from baseline to the end of the 4-week intervention will be evaluated.
Change in Pressure Pain Threshold Assessed by Pressure Algometry
时间窗: Pressure pain threshold (PPT) will be assessed using a pressure algometer at standardized measurement sites in the lumbar paraspinal region. Pressure will be gradually increased until the participant first reports that the pressure sensation has become p
Pressure pain threshold (PPT) will be assessed using a pressure algometer at standardized measurement sites in the lumbar paraspinal region. Pressure will be gradually increased until the participant first reports that the pressure sensation has become painful. The pressure value at this point will be recorded as the PPT. Higher PPT values indicate lower mechanical pain sensitivity.
次要结局
- Change in Functional Disability Assessed by the Oswestry Disability Index (ODI)(Baseline and immediately after the 4-week intervention)
- Change in Lumbar Flexion Mobility Assessed by the Modified Modified Schober Test (MMST)(Baseline and immediately after the 4-week intervention)
- Change in Back Extensor Muscle Endurance Assessed by the Sorensen Test(Baseline and immediately after the 4-week intervention)
研究者
Ayşenur Yılmaz
Assistant Professor
Burdur Mehmet Akif Ersoy University