Long COVIDNCT06476496
Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
A study testing Acupuncture in people with Long COVID and Pain, run by University of Washington at 1 site in United States.
Trial summary
The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of consent.
- Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization
- Report pain symptoms including musculoskeletal pain (joint, muscle, bone pain), chest pain, abdominal pain, headache, back pain, nerve pain, and pain in ear following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent.
- Report pain intensity (0-10 scale) ≥4 in the last 7 days.28
- As of today, has been seen by a clinician in the UW Long COVID Clinic either in-person or via telehealth/virtual visit
- Able to speak and read English and provide informed consent to complete the study requirements.
Who cannot join
- <18 years of age at the time of consent.
- Reports absence of pain, pain for less than 12 weeks, or a pain intensity <4 over the last 7 days.
- Report baseline level of pain for those who have pre-existing chronic pain (i.e., chronic pain condition(s) present prior to COVID-19 illness AND chronic pain not worsened post-COVID).
- Already received acupuncture treatment for long COVID symptoms.
- Unable to travel to the UW Northgate Clinic once a week for 8 weeks for acupuncture treatments.
- Has seizure disorder with high risk of seizure (i.e., new diagnosis of seizure disorder and/or new medication in the last 3 months, or uncontrolled/unclear triggers for seizures).
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- Is currently Pregnant
- Is receiving active cancer therapy
- Has severe neutropenia (<500 WBC) due to any cause within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Medicine Primary Care at Northgate
Seattle, Washington, 98125
About this study
The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care.
Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions.
Read the detailed description
Long-COVID has negatively impacted millions of individuals' quality of life, daily functioning, and ability to work, and has placed enormous demands on the healthcare system. Pain-related symptoms are reported by a large subset of patients with long COVID, and yet pain is still not consistently addressed in workups or treatment plans. Thus, we have chosen to study acupuncture for improving pain, quality of life, and function in individuals experiencing long COVID-related pain. Acupuncture has been shown to be successful in treating various types of chronic pain and should lend itself to similar results with pain related to long COVID. Furthermore, acupuncture focuses on treating the whole patient, which makes it uniquely well-suited for a complex condition affecting multiple body systems, like long COVID.
We propose an initial study to determine the feasibility of successfully conducting a subsequent fully-powered pragmatic randomized trial evaluating the effectiveness of Traditional Chinese Medicine (TCM) acupuncture for persistent pain problems experienced by persons with long COVID. Acupuncture is a physical treatment that aims to correct imbalances in the body (including inflammation and pain) within a Chinese Medicine paradigm.
Our specific aims are to:
- Assess the feasibility of conducting a randomized clinical trial comparing acupuncture with usual care alone for reducing pain in patients with long COVID;
- Evaluate the overall patient experience with participation in the feasibility trial and solicit suggestions about how the study procedures, documents, and treatment protocols could be improved to facilitate participation and better meet participants' needs; and
- Revise study procedures, protocols, and instruments to prepare for a fully-powered pragmatic randomized trial.
Participants randomized to acupuncture will receive a total of 8 weekly individual treatments lasting one hour each. Participants will lie supine on a treatment table while the acupuncturist inserts needles in selected body points. Bilateral needling of the pre-specified acupuncture points will be performed according to TCM principles and will include efforts to obtain De Qi.
This study has the potential to help patients with long COVID improve function and quality of life, and to provide clinicians with more tools to effectively respond to their patients' needs. This study will occur through the University of Washington (UW) Long COVID Clinic at the UW Primary Care Northgate Clinic site.
- Conditions
- Long COVID, Pain
- Being tested
- Acupuncture
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
A licensed acupuncturist will insert sterile disposable acupuncture needles in the selected body and ear acupoints aiming to alleviate long COVID related pain symptoms. Needles will be removed after 20 minutes of retention. After all the needles are removed, the acupuncturist will insert Pyonex press tack needles (0.3mm) in the participants' left ears and suggest the participants retain them in their ears for up to 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Participants will receive 8 sessions of acupuncture treatment Receives: Procedure: Acupuncture |
| Usual Care | No intervention | Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Enjoyment and General Activity (PEG)
The PEG is a widely used brief, three-item instrument that measures average pain intensity, enjoyment of life, and general activity in the past week, each rated on a 0 to 10 scale. Scores are calculated by averaging the scores of each of the three items. A higher score indicates worse pain impact.
Measured: Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20)
Secondary outcomes (4)
Pain Catastrophizing Scale (PCS) Short Form
The Pain Catastrophizing Scale (PCS) - Short Form is a 6-item self-report measure of catastrophic thinking related to pain, including rumination, magnification, and helplessness. PCS is a commonly used measure of pain experience and catastrophizing. Each measure is scored on a scale of 0 to 4. The PCS-SF score is determined by the sum of all 6 items; scores range from 0 to 24. Higher scores indicate greater catastrophizing.
Measured: Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20)
PROMIS-29
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a collection of person-centered tools that assess and track physical, mental, and social health in both adults and children. The PROMIS-29 Questionnaire includes 4-item short forms that measure anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and social role participation, along with a single item for pain intensity.
Raw scores were converted to T-scores (using an adult referent population), ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10 in the reference population. High scores indicate more of the concept being measured (e.g., for physical function and ability to participate in social activities, a higher score signifies greater function; for all other domains, a higher score indicates worse function). Pain intensity is a single item scored separately on a scale of 0 to 10, with higher scores representing worse pain.
Measured: Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20)
PROMIS Cognitive Function
The PROMIS Cognitive Function scale complements the PROMIS-29 with questions relevant to participants with Long COVID comorbidities, such as "brain fog." This scale measures patient-perceived cognitive deficits. Aspects include mental clarity, focus, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions. The scale consists of 8 items, each rated from 1 to 5 to generate a raw score; all 8 items must be answered for the scale to be scored. The T-score converts the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Measured: Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20)
UW Pain Related Self-Efficacy Scale (PRSE)
Pain-related self-efficacy is an individual's belief in their ability to accomplish important tasks and activities despite their pain. Identified subdomains include: Control/tolerance of/cope with symptoms, ability to manage the impact of pain on mood and psychological functioning, interpersonal relationships, and confidence to accomplish goals despite pain. The UW-PRSE was developed in a sample of adults living with chronic pain (mild to severe pain with average pain intensity of 3 or above on a scale from 0 to 10 for six months or longer and for at least half the days).
This study used the 6-item short form. Individual items are summed, and the total sum is then transformed to an IRT-based T-score. T-Scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. The mean score of the calibration sample included only individuals with chronic pain. A higher T-Score indicates higher self-efficacy.
Measured: Weeks 0, 8, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start21 Jun 2024
- Primary completion30 Mar 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Nikki Gentile, University of Washington
- Investigators
- Nikki Gentile, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476496
- Sponsor's protocol ID
- STUDY00019169
- Other IDs
- R34AT012679-01
- Status last verified
- May 2026
- First submitted
- 24 Jun 2024
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
- ClinicalTrials.gov ID
- NCT06476496
- Acronym / sponsor ID
- STUDY00019169
- Conditions
- Long COVID, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Posted 12 May 2026
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 preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care.
Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions.
Detailed description
Long-COVID has negatively impacted millions of individuals' quality of life, daily functioning, and ability to work, and has placed enormous demands on the healthcare system. Pain-related symptoms are reported by a large subset of patients with long COVID, and yet pain is still not consistently addressed in workups or treatment plans. Thus, we have chosen to study acupuncture for improving pain, quality of life, and function in individuals experiencing long COVID-related pain. Acupuncture has been shown to be successful in treating various types of chronic pain and should lend itself to similar results with pain related to long COVID. Furthermore, acupuncture focuses on treating the whole patient, which makes it uniquely well-suited for a complex condition affecting multiple body systems, like long COVID.
We propose an initial study to determine the feasibility of successfully conducting a subsequent fully-powered pragmatic randomized trial evaluating the effectiveness of Traditional Chinese Medicine (TCM) acupuncture for persistent pain problems experienced by persons with long COVID. Acupuncture is a physical treatment that aims to correct imbalances in the body (including inflammation and pain) within a Chinese Medicine paradigm.
Our specific aims are to:
- Assess the feasibility of conducting a randomized clinical trial comparing acupuncture with usual care alone for reducing pain in patients with long COVID;
- Evaluate the overall patient experience with participation in the feasibility trial and solicit suggestions about how the study procedures, documents, and treatment protocols could be improved to facilitate participation and better meet participants' needs; and
- Revise study procedures, protocols, and instruments to prepare for a fully-powered pragmatic randomized trial.
Participants randomized to acupuncture will receive a total of 8 weekly individual treatments lasting one hour each. Participants will lie supine on a treatment table while the acupuncturist inserts needles in selected body points. Bilateral needling of the pre-specified acupuncture points will be performed according to TCM principles and will include efforts to obtain De Qi.
This study has the potential to help patients with long COVID improve function and quality of life, and to provide clinicians with more tools to effectively respond to their patients' needs. This study will occur through the University of Washington (UW) Long COVID Clinic at the UW Primary Care Northgate Clinic site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureParticipants will receive 8 sessions of acupuncture treatment |
| Usual Care | No intervention | –Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age at the time of consent.
- Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization
- Report pain symptoms including musculoskeletal pain (joint, muscle, bone pain), chest pain, abdominal pain, headache, back pain, nerve pain, and pain in ear following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent.
- Report pain intensity (0-10 scale) ≥4 in the last 7 days.28
- As of today, has been seen by a clinician in the UW Long COVID Clinic either in-person or via telehealth/virtual visit
Key exclusion criteria (9 listed)
- <18 years of age at the time of consent.
- Reports absence of pain, pain for less than 12 weeks, or a pain intensity <4 over the last 7 days.
- Report baseline level of pain for those who have pre-existing chronic pain (i.e., chronic pain condition(s) present prior to COVID-19 illness AND chronic pain not worsened post-COVID).
- Already received acupuncture treatment for long COVID symptoms.
- Unable to travel to the UW Northgate Clinic once a week for 8 weeks for acupuncture treatments.
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 |
|---|---|---|
| AcupunctureA licensed acupuncturist will insert sterile disposable acupuncture needles in the selected body and ear acupoints aiming to alleviate long COVID related pain symptoms. Needles will be removed after 20 minutes of retention. After all the needles are removed, the acupuncturist will insert Pyonex press tack needles (0.3mm) in the participants' left ears and suggest the participants retain them in their ears for up to 5 days. | Procedure or surgery | Acupuncture |
Primary outcome
Pain, Enjoyment and General Activity (PEG)
Time frame: Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20)
The PEG is a widely used brief, three-item instrument that measures average pain intensity, enjoyment of life, and general activity in the past week, each rated on a 0 to 10 scale. Scores are calculated by averaging the scores of each of the three items. A higher score indicates worse pain impact.
4 secondary outcomes
Pain Catastrophizing Scale (PCS) Short Form
Time frame: Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20)
PROMIS-29
Time frame: Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20)
PROMIS Cognitive Function
Time frame: Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20)
UW Pain Related Self-Efficacy Scale (PRSE)
Time frame: Weeks 0, 8, 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
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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. This study is not recruiting at the moment.
Nikki Gentile, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Long COVID and Pain, run by University of Washington at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain, Enjoyment and General Activity (PEG) (time frame: Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20)). 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 12 May 2026.