An interventional study of Acupuncture in Long COVID and Pain, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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:
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.
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This study's enrollment of 93 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
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Exclusion Criteria:
Participants will receive 8 sessions of acupuncture treatment
Procedure: Acupuncture
Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms.
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.
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.
Time frame: Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 0, 8, 20
Total Time to Recruit All Study Participants
Timely recruitment of study participants (criteria: complete recruitment of 60 participants within five months);
Time frame: Prior to enrollment
Study Participants' Retention in Treatment Arm
Retention of participants in the treatment (criteria: 75% of participants attend at least 6 of 8 acupuncture visits)
Time frame: Weeks 1-8
Survey Response Rates
Questionnaire Response Rates: (criterion: 70% of participants complete baseline, mid-point, and post-treatment questionnaires; 75% complete final questionnaire) The baseline survey was required to complete enrollment.
Time frame: Weeks 0, 4, 8, 20
Adherance to the Treatment Protocol
Intervention fidelity (criteria: 80% of sessions fully adhere to the acupuncture treatment protocol). Each acupuncture visit was tracked, and a secondary acupuncturist provided quality control and reviewed the visit for fidelity to the acupuncture protocol.
Time frame: Weeks 1 - 8
Number of Visits Where Participants Adhered to Treatment Recommendations
Participant Adherence to treatment recommendations (criteria: 50% leave acupuncture needles in place for at least 3 days)
Time frame: Weeks 1-8
Individuals were recruited through the UW Long COVID Clinic. Those who opted in with the clinic to be contacted for research opportunities received an email describing the study and a link to the screener to determine eligibility. Recruitment was open for 2-3 weeks before the acupuncture sessions began until all open acupuncture spots were filled.
| Milestone | Acupuncture | Usual Care |
|---|---|---|
| Started | 46 | 47 |
| Completed | 35 | 46 |
| Not completed | 11 | 1 |
| Withdrew: Withdrawal by subject | 10 | 0 |
| Withdrew: Death | 0 | 01 |
| Withdrew: Withdrawal by study team | 1 | 0 |
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.
| Score | Acupuncture | Usual Care |
|---|---|---|
| Baseline (Week 0) | 6.74 ± 1.43 | 6.74 ± 1.51 |
| Midpoint (Week 4) | 8.33 ± 2.08 | 9.33 ± 1.91 |
| Post-Intervention (Week 8) | 4.95 ± 2.14 | 6.03 ± 2.11 |
| Final Follow-Up (Week 20) | 4.77 ± 2.22 | 5.89 ± 1.97 |
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.
| Score | Acupuncture | Usual Care |
|---|---|---|
| Baseline (Week 0) | 12.37 ± 5.91 | 12.62 ± 5.38 |
| Post-Intervention (Week 8) | 9.48 ± 5.81 | 11.68 ± 5.96 |
| Final Follow-Up (Week 20) | 7.52 ± 5.91 | 11.97 ± 5.45 |
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.
| Scores | Acupuncture | Usual Care |
|---|---|---|
| Ability to Participate in Social Roles: Baseline (Week 0) | 37.44 ± 6.44 | 37.62 ± 7.86 |
| Ability to Participate in Social Roles: Post Intervention (Week 8) | 38.95 ± 6.7 | 37.03 ± 8.23 |
| Ability to Participate in Social Roles: Final Follow-Up (Week 20) | 40.39 ± 7.4 | 37.97 ± 7.66 |
| Anxiety/Fear: Baseline (Week 0) | 60.47 ± 10.31 | 59.78 ± 9.99 |
| Anxiety/Fear: Post Intervention (Week 8) | 60.3 ± 9.02 | 61.56 ± 8.11 |
| Anxiety/Fear: Final Follow-Up (Week 20) | 60.95 ± 12.16 | 61.29 ± 8.04 |
| Depression/Sadness: Baseline (Week 0) | 58.84 ± 9.42 | 57.78 ± 10.14 |
| Depression/Sadness: Post Intervention (Week 8) | 58.3 ± 9.56 | 58.62 ± 9.48 |
| Depression/Sadness: Final Follow-Up (Week 20) | 58.89 ± 9.7 | 58.41 ± 10.15 |
| Fatigue: Baseline (Week 0) | 68.92 ± 6.72 | 68.26 ± 7.91 |
| Fatigue: Post Intervention (Week 8) | 66.06 ± 7.6 | 69.22 ± 8.15 |
| Fatigue: Final Follow-Up (Week 20) | 66.04 ± 8.42 | 66.1 ± 8.74 |
| Pain Interference: Baseline (Week 0) | 65.69 ± 5.18 | 65.18 ± 6.13 |
| Pain Interference: Post Intervention (Week 8) | 61.11 ± 8.3 | 64.51 ± 6.95 |
| Pain Interference: Final Follow-Up (Week 20) | 62.62 ± 6.94 | 65.11 ± 6.26 |
| Physical Function: Baseline (Week 0) | 36.79 ± 5.66 | 36.74 ± 6.77 |
| Physical Function: Post Intervention (Week 8) | 38.81 ± 6.03 | 37 ± 7.94 |
| Physical Function: Final Follow-Up (Week 20) | 59.06 ± 8.2 | 57.27 ± 7.05 |
| Sleep Disturbance: Baseline (Week 0) | 59.05 ± 7.48 | 59.66 ± 7.22 |
| Sleep Disturbance: Post Intervention (Week 8) | 56.62 ± 6.98 | 59.52 ± 6.88 |
| Sleep Disturbance: Final Follow-Up (Week 20) | 59.06 ± 8.2 | 57.27 ± 7.05 |
| Pain Intensity: Baseline (Week 0) | 6.22 ± 1.26 | 6.38 ± 1.44 |
| Pain Intensity: Post Intervention (Week 8) | 4.81 ± 1.99 | 6.05 ± 1.92 |
| Pain Intensity: Final Follow-Up (Week 20) | 4.9 ± 2.2 | 6.2 ± 1.83 |
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.
| Scores | Acupuncture | Usual Care |
|---|---|---|
| Baseline (Week 0) | 33.52 ± 8.97 | 31.56 ± 8.36 |
| Post Intervention (Week 8) | 35.62 ± 10.05 | 33.04 ± 8.25 |
| Final Follow-Up (Week 20) | 37.87 ± 10.48 | 32.92 ± 8.44 |
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.
| T-Scores | Acupuncture | Usual Care |
|---|---|---|
| Baseline (Week 0) | 44.24 ± 7.25 | 43.71 ± 8.02 |
| Post Intervention (Week 8) | 47.75 ± 7.88 | 45.23 ± 10.89 |
| Final Follow-Up (Week 20) | 44.9 ± 10.06 | 44.98 ± 9.24 |
Timely recruitment of study participants (criteria: complete recruitment of 60 participants within five months);
| months | Study Participants |
|---|---|
| Total Time to Recruit All Study Participants | 3 |
Retention of participants in the treatment (criteria: 75% of participants attend at least 6 of 8 acupuncture visits)
| Participants | Acupuncture |
|---|---|
| Study Participants' Retention in Treatment Arm | 29 |
Questionnaire Response Rates: (criterion: 70% of participants complete baseline, mid-point, and post-treatment questionnaires; 75% complete final questionnaire) The baseline survey was required to complete enrollment.
| Participants | Acupuncture | Usual Care |
|---|---|---|
| Baseline (Week 0) | 46 | 47 |
| Midpoint (Week 4) | 33 | 38 |
| Post-Intervention (Week 8) | 31 | 38 |
| Final Follow-Up (Week 20) | 31 | 35 |
Intervention fidelity (criteria: 80% of sessions fully adhere to the acupuncture treatment protocol). Each acupuncture visit was tracked, and a secondary acupuncturist provided quality control and reviewed the visit for fidelity to the acupuncture protocol.
| Acupuncture Visits | Acupuncture |
|---|---|
| Adherance to the Treatment Protocol | 228 |
Participant Adherence to treatment recommendations (criteria: 50% leave acupuncture needles in place for at least 3 days)
| AcupunctureVisits | Acupuncture |
|---|---|
| Number of Visits Where Participants Adhered to Treatment Recommendations | 202 |
Collected over From enrollment until the end of follow-up (week 20). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acupuncture | 1/46 (2.2%) | 10/46 (21.7%) | 9/46 (19.6%) |
| Usual Care | 1/47 (2.1%) | 11/47 (23.4%) | 0/47 (0%) |
| Event | Acupuncture | Usual Care |
|---|---|---|
| Musculoskeletal pain or injuryMusculoskeletal and connective tissue disorders | 3/46 | 2/47 |
| Hospitalized for planned surgerySurgical and medical procedures | 1/46 | 3/47 |
| Psychiatric disorders (psychosis)Psychiatric disorders | 2/46 | 0/47 |
| Abdominal painGastrointestinal disorders | 0/46 | 2/47 |
| Accidental injury (fracture or foreign body)Injury, poisoning and procedural complications | 0/46 | 2/47 |
| Cardiac symptoms (palpitations or chest pain)Cardiac disorders | 1/46 | 1/47 |
| Eye disorder (acute vision loss)Eye disorders | 1/46 | 0/47 |
| General symptoms requiring evaluationGeneral disorders | 1/46 | 0/47 |
| Genitourinary or gynecologic symptomsRenal and urinary disorders | 1/46 | 1/47 |
| Genitourinary or gynecologic symptomsReproductive system and breast disorders | 1/46 | 0/47 |
| Event | Acupuncture | Usual Care |
|---|---|---|
| Localized pain at needle siteSkin and subcutaneous tissue disorders | 5/46 | 0/47 |
| Bruising at the needle siteSkin and subcutaneous tissue disorders | 4/46 | 0/47 |
| Age, Continuous(years) | Acupuncture | Usual Care | Total |
|---|---|---|---|
| Mean | 45.15 ± 12.25 | 46.47 ± 12.67 | 45.82 ± 12.41 |
| Sex/Gender, Customized(Participants) | Acupuncture | Usual Care | Total |
|---|---|---|---|
| Female | 34 | 35 | 69 |
| Male | 12 | 11 | 23 |
| Prefer Not to Answer | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Acupuncture | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 33 | 29 | 62 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 5 | 8 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Acupuncture | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 8 | 10 |
| Not Hispanic or Latino | 42 | 36 | 78 |
| Unknown or Not Reported | 2 | 3 | 5 |
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