Effect of Combination Therapy With Atelocollagen in Epidural Nerve Block in Patients With Chronic Low Back Pain From Degenerative Lumbar Spine: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- cross-sectional area of the multifidus muscle
研究概览
简要总结
"In this study, the investigators plan to evaluate muscle mass and pain relief 4 weeks after performing epidural nerve block and Type I porcine atelocollagen injection into multifidus muscle in patients with chronic low back pain due to degenerative spinal disease for more than 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for epidural nerve block for lower back pain
- •Patients over 21 years of age
- •Back pain lasting more than 6 months
- •Patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain
- •Patients with spinal stenosis or disc herniation at the lumbar 4-5 or lumbar 5-sacral 1 level on MRI, and the cross-sectional area of the multifidus muscle at the lesion site is less than 5 cm2 when measured by ultrasound.
排除标准
- •When the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter NRS)
- •If lower back pain has rapidly worsened within the last week
- •If you have other diseases that may cause low back pain: osteoarthritis of the hip joint, cancer, inflammatory arthritis, spondylitis, fibromyalgia, complex regional pain syndrome, herpes zoster, postherpetic neuralgia, etc.
- •When a diagnostic epidural nerve block is planned
- •In the case of receiving conservative treatment, procedure, or surgery other than oral drugs such as epidural nerve block or proliferation treatment for the treatment of lower back pain within 4 weeks of screening
- •When the low back pain assessed by NRS decreased by more than 50% after epidural nerve block in screening
- •If back surgery is planned within 3 months of the procedure
- •When NRS and ODI measurements cannot be made
- •When collagen injection is contraindicated (eg when allergic to swine)
- •Pregnant women
- •If you cannot read or agree to the consent form
- •If you are unable to sign the consent form yourself
研究组 & 干预措施
Atelocollagen group
After obtaining informed consent for the study, epidural nerve block was performed. The patient is asked to return to the outpatient clinic of the pain center after 2 weeks. At this time, when the NRS of back pain does not improve by more than 50% compared to before the epidural nerve block and the cross-sectional area of the multifidus muscle using ultrasound is 5 cm2 or less, final enrollment is decided. The evaluation of the cross-sectional area and thickness of the multifidus muscle using ultrasound is performed with the patient prone, and the cross-sectional area of the multifidus muscle is measured at the same position as the level of the lesion on MRI.
干预措施: (atelocollagen group) (Procedure)
结局指标
主要结局
cross-sectional area of the multifidus muscle
时间窗: 28 days after atelocollagen injection
Changes in the cross-sectional area of the multifidus muscle at the 4th week of the intervention compared to before the intervention (measured value using ultrasound at outpatient).
次要结局
- numeric rating score(28 days after atelocollagen injection)
- oswestry disability index(28 days after atelocollagen injection)
研究者
Ji Yeong Kim
Associate Professor
Gangnam Severance Hospital