Comparison of the Effectiveness of High-Intensity Laser Therapy and Transforaminal Epidural Steroid Injection in Patients With Chronic Axial and Radicular Low Back Pain Due to Lumbar Disc Herniation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Low Back and Leg Pain Intensity Assessed by Visual Analog Scale
研究概览
简要总结
This prospective, randomized, single-blinded, controlled clinical trial aims to compare the effectiveness of high-intensity laser therapy and fluoroscopy-guided transforaminal epidural steroid injection in patients with chronic low back pain and lumbar radiculopathy. Eligible patients will be randomized into two parallel groups. One group will receive high-intensity laser therapy, and the other group will receive transforaminal epidural steroid injection. All participants will also receive a standardized home-based exercise program. Outcomes will be assessed at baseline, 2 weeks, 6 weeks, and 12 weeks after treatment. The primary outcome will be pain intensity measured by the Visual Analog Scale. Secondary outcomes will include functional disability, neuropathic pain symptoms, quality of life, and functional walking capacity.
详细描述
Low back pain is one of the most common musculoskeletal complaints and may lead to substantial disability and reduced quality of life. Lumbar disc herniation is a frequent cause of chronic axial and radicular low back pain.
High-intensity laser therapy is a non-invasive physical therapy modality with analgesic, anti-inflammatory, and biostimulatory effects. Transforaminal epidural steroid injection is a minimally invasive interventional treatment commonly used for radicular pain associated with lumbar disc herniation.
This prospective randomized controlled trial will include adult patients aged 18 to 65 years with chronic axial and radicular low back pain due to lumbar disc herniation. Participants will be randomized into two parallel groups. One group will receive high-intensity laser therapy for 15 sessions over 3 weeks, and the other group will receive fluoroscopy-guided transforaminal epidural steroid injection. All participants will receive a standardized home-based exercise program. Outcomes will be assessed at baseline, 2 weeks, 6 weeks, and 12 weeks after treatment.
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)
盲法说明
The outcomes assessor will be blinded to treatment allocation.
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
- •Age between 18 and 65 years
- •Diagnosis of lumbar disc herniation confirmed by clinical examination and lumbar magnetic resonance imaging
- •Chronic axial low back pain and radicular pain related to lumbar disc herniation
- •Low back and/or radicular pain lasting longer than 3 months
- •Resting low back and/or radicular pain intensity of ≥5 on a 0-10 visual analog scale
- •Willingness to participate in the study and provide written informed consent
排除标准
- •Pregnancy or suspected pregnancy
- •Presence of a cardiac pacemaker
- •History of epilepsy
- •Active or previous malignancy
- •History of spinal surgery
- •Uncontrolled systemic or psychiatric disease
- •Cauda equina syndrome or progressive neurological deficit
- •Peripheral neuropathy, including diabetic or alcohol-related neuropathy
- •Neurodegenerative disease
- •Acute trauma
- •Active systemic infection
- •Local infection or skin disease at the injection site or treatment area
- •Body mass index greater than 40 kg/m²
- •Bleeding disorder that contraindicates treatment
- •Spinal stenosis, spondylolysis, or spondylolisthesis
- •Neurogenic bladder or bowel syndrome
- •Rheumatologic disease
- •Arterial vascular disease or vascular claudication
- •Receipt of other physical therapy modalities within the last 3 months
- •Receipt of spinal injection therapy within the last 3 months
- •History of allergy to injection agents
结局指标
主要结局
Change in Low Back and Leg Pain Intensity Assessed by Visual Analog Scale
时间窗: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Pain intensity at rest will be assessed using the visual analog scale. Participants will be asked to indicate their current low back and radicular leg pain intensity on a 10-cm horizontal line, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
次要结局
- Change in Disability Assessed by the Oswestry Disability Index(Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment)
- Change in Neuropathic Pain Assessed by the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale(Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment)
- Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey(Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment)
- Change in Functional Walking Capacity Assessed by the Six-Minute Walk Test(Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment)
研究者
Esra Ülgen Kıratlıoğlu
MD
Ankara City Hospital Bilkent