Real-World Study of Acupuncture for Pain Control

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
• Intervention / Treatment: Procedure: Acupuncture-First Stepped Care Pathway (Routine Clinical Care)

• Study Type: Observational
• Enrollment (Estimated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The initial analytic cohort will include approximately 300 pain episodes, anticipated to be derived from 250-350 unique adult patients, recognizing that some patients may contribute more than one episode over time. Pain episodes may originate from either clinical site and are analyzed together under the same episode-based framework.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Acupuncture-First Stepped Care Cohort

Procedure: Acupuncture-First Stepped Care Pathway (Routine Clinical Care); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Pain Episodes Achieving Clinically Meaningful Improvement	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.	From baseline (initial visit) through episode closure, up to 12 weeks (maximum of 8 visits)

Collaborators and Investigators

• Sponsor: Qi's Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): March 21, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): September 21, 2027

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00093169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No