NCT05014945已完成不适用
Effect of Combination Therapy With Atelocollagen in Epidural Nerve Block in Patients With Chronic Low Back Pain From Degenerative Lumbar Spine: Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 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
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
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of patch type atelocollagen in rotator cuff repairDiseases of the musculoskeletal system and connective tissueKCT0005184The Catholic University of Korea, Eunpyeong St. Mary's Hospital55
招募中
4 期
Effect of Atelocollagen Injection in Patients With Calcific TendinitisCalcific Tendinitis of ShoulderAtelocollagenNCT06040112Hyungsuk Kim46
Enrolling By Invitation
不适用
Evaluation of the Efficacy of the ALLYANE Procedure in the Treatment of Central Motor InhibitionNCT06774157Allyane120
已完成
不适用
Effects of Collagen Peptide Supplementation on Muscle and Tendon Damage and FunctionExerciseHealthy Male SubjectsNCT05425407KU Leuven22
Unknown
不适用
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee ArthroplastyPain, PostoperativeNCT04574791Rothman Institute Orthopaedics240