Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
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
🗓️ Study Start (Actual) 21 June 2024
🗓️ Primary Completion (Estimated) 1 June 2025
✅ Study Completion (Estimated) 1 June 2025
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Seattle, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * ≥ 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.

    Exclusion Criteria:

    • * \<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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 June 2024
  • First Submitted that Met QC Criteria 24 June 2024
  • First Posted 26 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 June 2024
  • Last Update Posted 26 June 2024
  • Last Verified June 2024