Evaluation of an Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain: A Prospective, Randomized, Comparative Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain changes in low back pain
研究概览
简要总结
The purpose of this study was to evaluate the effectiveness and safety of atelocollagen in the management of chronic low back pain with sarcopenia due to degenerative changes.
详细描述
Patients with chronic low back pain are enrolled and divided into group A (atelocollagen) and group B (control) through randomization after obtaining informed consent.
Investigators record tender points for the multifidus, erector spinae, and quadratus lumborum muscles by physical examination.
Investigators evaluate each muscle using ultrasound according to the assignment of each group, and apply atelocollagen mixture (atelocollagen 3 mL + 1% lidocaine 3 mL) or local anesthetics only (normal saline 3 mL + 1% lidocaine 3 mL) to each muscle on both sides.
The subject of the study performs a total of 3 injections at intervals of 2 weeks, and each measurement variable is collected by visiting 4 weeks and 12 weeks after the last injection.
Changing medications or additive interventions are not allowed before 4 weeks after last injection. Only acetaminophen is allowed as a rescue drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-specific low back pain with persistent paraspinal tenderness of NRS 4 or higher despite conservative treatment (including physical therapy, exercise therapy, oral drug administration, and epidural block) for at least 3 months.
- •Adults 19 years of age or older
排除标准
- •Systemic or local infection Coagulopathy Patients whose structure is difficult to confirm on ultrasound due to significant deformity of the lumbar spine Neoplasm of spine Cognitive disorder Patients with hypersensitivity to local anesthetics or amide-based local anesthetics Patients those who are allergic to or sensitive to atelocollagen ingredients or pork Women who are pregnant, lactating, or planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods Those who participated in other clinical trials within 30 days prior to screening or 5 times the half-life of the investigational drug in the clinical trial in which they participated, whichever is longer, whichever is longer Patients with serious systemic diseases
结局指标
主要结局
Pain changes in low back pain
时间窗: 4 weeks after last intervention
The changes of the 11-point Numeric Rating Scale(NRS) pain score (numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")) after intervention between two groups.
次要结局
- Oswestry Disability Index(ODI) score(4, 12 weeks after last intervention)
- Pain changes in low back pain(12 weeks after last intervention)
- Satisfaction (pain physician)(4 weeks after first intervention)
- Pain related to intervention(4 weeks after first intervention)
- Satisfaction (participants)(4 weeks after first intervention)
- Medication(12 weeks after last intervention)
- Cross-sectional area(4, 12 weeks after last intervention)
研究者
Jeeyoun Moon
Associate professor
Seoul National University