NCT06476496

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Long COVID
• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-21
• Primary completion: 2025-03-30
• Completion: 2025-06-23
• First posted: 2024-06-26
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States