Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476496
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-24
Brief Title:
Pain Relief With Integrative Medicine PRIMe Feasibility of Acupuncture for Long COVID
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Pain Relief With Integrative Medicine PRIMe Feasibility of Acupuncture for Long COVID
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AT012679-01 | NIH | None | None |