Clinical trial NCT06476496: Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
Official title: Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long COVID
Pain
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain, Enjoyment and General Activity (PEG)
timeFrame: Weeks 0, 4, 8, 20
Secondary outcomes:
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Weeks 0, 8, 20
measure: PROMIS-29
timeFrame: Weeks 0, 8, 20
measure: PROMIS Cognitive Function
timeFrame: Weeks 0, 8, 20
measure: UW Pain Related Self-Efficacy Scale (PRSE)
timeFrame: Weeks 0, 8, 20
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Medicine Primary Care at Northgate
state: Washington
Study officials:
affiliation: University of Washington
name: Nikki Gentile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: