The goal of this preliminary study is to test methods and procedures to be used in afully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, wewill test the feasibility of conducting a 2-arm randomized clinical trial for evaluatingthe effectiveness of acupuncture for pain in patients with long COVID. Researchers willcompare pain intensity and impact on general activities over 5 months in those whoreceive acupuncture treatment compared to patients who are receiving usual long COVIDcare.Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveysinclude validated mental and physical health questionnaires. Participants who arerandomly selected to receive the intervention will receive 8 acupuncture treatmentsessions.
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:
1. Assess the feasibility of conducting a randomized clinical trial comparing
acupuncture with usual care alone for reducing pain in patients with long COVID;
2. 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
3. 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.
Procedure: Acupuncture
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.
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
UW Medicine Primary Care at Northgate
Seattle, Washington, United States
Nikki Gentile, MD, PhD, Principal Investigator
University of Washington