NCT06444035Enrolling By Invitation不适用
35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome
Nakhia Impex LLC1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Chronic myofascial pain score
研究概览
简要总结
To verify the efficacy and safety of HA35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study. This study aims to evaluate the 15-day treatment of HA35 on patients with myofascial pain syndrome and to observe the effects for up to 3 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, aged 18-65 years old ;
- •suffering from muscle strain, sprain, fall, wind and other diagnosed as myofascitis in patients with chronic back pain;
- •the pain reported by the subject should reach level 3 or higher on the digital rating scale of 0-10 ( 0 means no pain, 10 represents the strongest pain imaginable );
- •the mental state is good, and the pain level can be evaluated independently;
- •be able to cooperate with the treatment independently and sign a written consent.
排除标准
- •Previous severe trauma with permanent musculoskeletal dysfunction;
- •symptomatic lumbar disc herniation with neurological deficits;
- •specific spinal diseases, including rheumatoid arthritis, ankylosing spondylitis, and osteoporosis;
- •diagnosed with mental illness;
- •agree not to sign the written consent;
- •pregnant, lactating or fertile women;
- •currently participating ( or participating in the past 30 days ) in research-based treatment or equipment trials.
研究组 & 干预措施
Treatment of myofascial pain syndrome by local injection of pain points
Experimental
Subjects received subcutaneous injection of HA35 injection 100mg / 5mL / day near the back pain point for 15 days.
干预措施: HA35 injection (Drug)
结局指标
主要结局
Chronic myofascial pain score
时间窗: after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days
Subjective measurements of pain were submitted using the Numerical Pain Rating Scale (NPRS). Scored at 0-10, the higher the score, the more obvious the pain.
次要结局
- Overall pain assessment during injection therapy and follow-up(after treatment 15 days, 30 days, 60 days, 90 days)
- Satisfaction survey of injection treatment(after treatment 90 days)
研究者
研究点 (1)
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