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NCT Number: NCT07454083

Real-World Study of Acupuncture for Pain Control

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.

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Key information

Conditions

Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Acupuncture-First Stepped Care Pathway (Routine Clinical Care)

Procedure

This study does not assign or manipulate any intervention. Participants receive routine outpatient acupuncture care delivered within an existing acupuncture-first stepped care pathway.

The pathway represents standard clinical practice and includes individualized acupuncture treatment decisions made by the treating practitioner. Treatment frequency, duration (up to 8 visits per episode), and potential care escalation are determined solely by routine clinical judgment and patient response.

The study does not introduce additional procedures, randomization, comparison groups, or protocol-driven treatment modifications. Data are analyzed observationally from routine clinical documentation.

Primary outcomes

Proportion of Pain Episodes Achieving Clinically Meaningful Improvement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qi's Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 6, 2026
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.