Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID

NCT06476496 | Completed Results DMC

• 2 other identifiers: STUDY00019169R34AT012679-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Long COVID; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20)

• PROMIS-29

  Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20)

• PROMIS Cognitive Function

  Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20)

• UW Pain Related Self-Efficacy Scale (PRSE)

  Weeks 0, 8, 20

Other Outcomes (5)

• Total Time to Recruit All Study Participants

  Prior to enrollment

• Study Participants' Retention in Treatment Arm

  Weeks 1-8

• Survey Response Rates

  Weeks 0, 4, 8, 20

Study Arms (2)

Acupuncture

EXPERIMENTAL

Participants will receive 8 sessions of acupuncture treatment

Procedure: Acupuncture

Usual Care

NO INTERVENTION

Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms.

Interventions

Acupuncture PROCEDURE

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.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• \<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).
• Is currently Pregnant
• Is receiving active cancer therapy
• Has severe neutropenia (\<500 WBC) due to any cause within the last 6 months

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UW Medicine Primary Care at Northgate

Seattle, Washington, 98125, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

This is a small proof-of-concept study.

Results Point of Contact

• Title: Nicole Gentile
• Organization: University of Washington

ngentile@uw.edu

206-616-3961

Study Officials

• Nikki Gentile, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Medicine

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 26, 2024
• Study Start: June 21, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 23, 2025
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-05

Locations

US (1)