Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute PainNCT07454083
Real-World Study of Acupuncture for Pain Control
An observational study of Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain, run by Qi's Clinic.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
- What is being tested?
- Acupuncture-First Stepped Care Pathway (Routine Clinical Care)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2026to 21 Sep 2027
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18 years or older
- Patients presenting with non-cancer-related pain conditions
- Patients receiving acupuncture as part of routine outpatient clinical care
Who cannot join
- Cancer-related pain conditions
- Patients who opt out of research use of their clinical data
About this study
Official 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
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:
Read more
- 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.
- Being tested
- Acupuncture-First Stepped Care Pathway (Routine Clinical Care)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture-First Stepped Care Pathway (Routine Clinical Care)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture-First Stepped Care Cohort | Not described Receives: Procedure: Acupuncture-First Stepped Care Pathway (Routine Clinical Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (initial visit) through episode closure, up to 12 weeks (maximum of 8 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start21 Mar 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion21 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Qi's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454083
- Sponsor's protocol ID
- Pro00093169
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07454083
- Acronym / sponsor ID
- Pro00093169
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qi's ClinicUniversity, hospital or other
- Study start
- 21 Mar 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 21 Sep 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture-First Stepped Care Cohort | – | Procedure: Acupuncture-First Stepped Care Pathway (Routine Clinical Care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Patients presenting with non-cancer-related pain conditions
- Patients receiving acupuncture as part of routine outpatient clinical care
Key exclusion criteria (2 listed)
- Cancer-related pain conditions
- Patients who opt out of research use of their clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Acupuncture-First Stepped Care Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain, run by Qi's Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.