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临床试验/NCT07454083
NCT07454083尚未招募不适用

Qi's Clinic, Real-World Effectiveness of an Acupuncture-First Stepped Care Pathway for Pain Management: An Episode-Based Observational Study in Routine Outpatient Clinical Practice Supported by an ES-Enabled Clinical System

Qi's Clinic0 个研究点目标入组 300 人开始时间: 2026年3月21日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Proportion of Pain Episodes Achieving Clinically Meaningful Improvement

研究概览

简要总结

The goal of this observational study is to evaluate the real-world effectiveness of an acupuncture-first stepped care pathway for pain management in adults aged 18 years and older receiving routine outpatient clinical care for non-cancer-related pain conditions. The primary purpose is to describe episode-based clinical outcomes and care utilization patterns as they occur in standard practice.

The main questions it aims to answer are:

  • What proportion of completed pain episodes achieve a clinically meaningful improvement, defined as a ≥50% reduction in pain intensity (Numeric Rating Scale or Visual Analog Scale) within an episode treatment window of up to 8 acupuncture visits?
  • What are the visit utilization patterns, time to clinically meaningful improvement, and care escalation patterns within an acupuncture-first stepped care pathway in routine outpatient practice?

There is no comparison group. This study does not introduce or test a new intervention. All care is delivered as part of standard clinical practice.

Participants will:

  • Receive acupuncture treatment as part of routine outpatient care
  • Undergo routine pain assessments (NRS/VAS) at each clinical visit
  • Participate in standard clinical follow-up as determined by usual care practices

No additional research-specific visits, procedures, questionnaires, or interventions are introduced. Data analyzed in this study are derived from routine clinical documentation systems and are de-identified prior to analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older
  • Patients presenting with non-cancer-related pain conditions
  • Patients receiving acupuncture as part of routine outpatient clinical care

排除标准

  • Cancer-related pain conditions
  • Patients who opt out of research use of their clinical data

研究组 & 干预措施

Acupuncture-First Stepped Care Cohort

干预措施: Acupuncture-First Stepped Care Pathway (Routine Clinical Care) (Procedure)

结局指标

主要结局

Proportion of Pain Episodes Achieving Clinically Meaningful Improvement

时间窗: From baseline (initial visit) through episode closure, up to 12 weeks (maximum of 8 visits)

Clinically meaningful improvement is defined as a ≥50% reduction in pain intensity from baseline, measured using the Numeric Rating Scale (NRS) or Visual Analog Scale (VAS). The outcome is assessed at the final observed visit within the episode treatment window (up to 8 acupuncture visits) or at episode closure, whichever occurs first.

次要结局

未报告次要终点

研究者

发起方
Qi's Clinic
申办方类型
Other
责任方
Sponsor

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