Safety and Efficacy of Pulsed RF Neuromodulation and Leukocyte-Rich PRP for the Treatment of Refractory Low Back Pain Due to Multifidus Dysfunction
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (0-50)
研究概览
简要总结
This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. The trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy.
详细描述
Low back pain is a common condition, often associated with multifidus muscle dysfunction, which can result from aging, obesity, or limited movement. This dysfunction is characterized by fatty infiltration and loss of muscle function. Surgical procedures involving posterior or transpedicular screw insertion can exacerbate this issue by damaging the multifidus muscle, leading to persistent pain.
This study will investigate the effects of pulsed RF neuromodulation on the L2 and L3 segments bilaterally, with each side receiving treatment for 6 minutes. In addition, leukocyte-rich PRP will be injected into the multifidus muscle, and patients will undergo a physiotherapy regimen. The primary outcomes will be compared with those of a control group receiving only physical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory low back pain due to multifidus dysfunction.
- •Pain persisting for more than 6 months despite conventional treatments.
- •Ability to provide informed consent.
排除标准
- •Previous spinal surgery within the last year.
- •Current use of systemic steroids or immunosuppressive medications.
- •Known bleeding disorders or anticoagulant therapy.
- •Pregnancy or lactation.
- •Severe psychiatric or cognitive disorders.
- •Any Congenital or Non-congenital disorders
研究组 & 干预措施
Experimental Group
Pulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each.
Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen.
干预措施: Pulsed RF Neuromodulation (Procedure)
Experimental Group
Pulsed RF Neuromodulation: Administered to the L2 and L3 segments bilaterally for 6 minutes each.
Leukocyte-Rich PRP Injection: Injected into the multifidus muscle. Physiotherapy: Standard physiotherapy regimen.
干预措施: Leukocyte-Rich PRP Injection (Biological)
Control Group
Physiotherapy: Standard physiotherapy regimen only
干预措施: Physiotherapy Alone (Procedure)
结局指标
主要结局
Oswestry Disability Index (0-50)
时间窗: 1 Year
Change in disability index from baseline
Pain Visual Analog Scale (0-10)
时间窗: 1 Year
Change in pain intensity from baseline
Quality of Life (0-100)
时间窗: 1 Year
Change in Quality of life from baseline
Hospital Anxiety and Depression Scale (0-14)
时间窗: 1 Year
Change in anxiety and depression levels from baseline
次要结局
未报告次要终点