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Clinical Trials/ChiCTR2200063043
ChiCTR2200063043Not yet recruitingPhase 1

评估注射用胶原酶治疗颈椎间盘突出症的有效性和安全性：一项探索性、单臂、开放、多中心试验

自筹9 sites in 1 country142 target enrollmentStarted: August 28, 2022Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
142
Locations
9
Primary Endpoint
Odom 评分
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

本研究的目的是评估胶原酶溶解术治疗颈椎间盘突出症的有效性和安全性。

Study Design

Study Type
干预性研究
Primary Purpose
单臂

Eligibility Criteria

Ages
18 to 65 (—)
Sex
All

Inclusion Criteria

  • •18≦年龄≦65 岁，性别不限；
  • •临床症状和影像学（包含 X 射线、CT 和 MRI）均符合临床诊断；
  • •保守治 6 周疗无效或在保守治疗过程中出现进行性症状或出现神经根压迫迹象，患者治疗意愿强烈；
  • •主要体征和症状是单侧神经根性颈肩臂痛、上肢及手部的疼痛麻木等；
  • •NDI 指数＞30 分，满分 100 分；
  • •NRS 分数＞3 分，满分 10 分；
  • •患者在社会心理学，精神、身体等层面上完全遵循本协议，包括遵循预定的访问，治疗计划，填写表格且能完成理解量表内容。

Exclusion Criteria

  • •并骨性椎管狭窄出现神经卡压；
  • •颈椎间盘突出症已出现脊髓受压变性或瘫痪者；
  • •严重的原发性疾病或未控制的感染，包括肾脏、心脏或肝病、造血系统、内分泌系统疾病或怀孕或母乳喂养
  • •合并影响肌肉骨骼系统的自身免疫性疾病（即狼疮、类风湿性关节炎或强直性脊柱炎）；
  • •有明显社会心理疾病，沟通障碍的患者；
  • •经研究者评估其他不适合参与研究的患者。

Arms & Interventions

1 组

注射胶原酶

Outcomes

Primary Outcomes

Odom 评分

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
自筹

Study Sites (9)

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