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Behavioural Intervention
Acupuncture for Post-COVID Syndrome
N/A
Recruiting
Led By Nikki Gentile, MD, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Report pain intensity (0-10 scale) ≥4 in the last 7 days
≥ 18 years of age at the time of consent
Must not have
Is receiving active cancer therapy
Has severe neutropenia (<500 WBC) due to any cause within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 4, 8, 20
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test methods for a larger study on acupuncture treatment for pain in long COVID patients. They will compare the effectiveness of acupuncture treatment to usual care by looking at pain levels and daily activities impact
Who is the study for?
This trial is for individuals experiencing pain due to long COVID. Participants must be willing to complete online health surveys and attend acupuncture sessions if selected. Specific inclusion and exclusion criteria details are not provided, but typically involve factors like age, overall health status, and the severity of symptoms.
What is being tested?
The study is testing whether acupuncture can help reduce pain in patients with long COVID compared to usual care. It's a preliminary study designed as a randomized clinical trial where some participants will receive acupuncture over five months while others continue their regular treatments.
What are the potential side effects?
Acupuncture is generally considered safe when performed by an experienced practitioner. Possible side effects include soreness, minor bleeding or bruising at needle sites, dizziness or fainting. Serious side effects are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain level has been 4 or higher in the past week.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently undergoing treatment for cancer.
Select...
I have had very low white blood cell counts in the last 6 months.
Select...
I am under 18 years old.
Select...
I have received acupuncture for long COVID symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 4, 8, 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 8, 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain, Enjoyment and General Activity (PEG)
Secondary study objectives
PROMIS Cognitive Function
PROMIS-29
Pain Catastrophizing Scale (PCS)
+1 moreSide effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AcupunctureExperimental Treatment1 Intervention
Participants will receive 8 sessions of acupuncture treatment
Group II: Usual CareActive Control1 Intervention
Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
National Center for Complementary and Integrative Health (NCCIH)NIH
854 Previous Clinical Trials
671,680 Total Patients Enrolled
35 Trials studying Pain
21,589 Patients Enrolled for Pain
University of WashingtonLead Sponsor
1,814 Previous Clinical Trials
1,912,953 Total Patients Enrolled
25 Trials studying Pain
13,753 Patients Enrolled for Pain
Nikki Gentile, MD, PhDPrincipal InvestigatorUniversity of Washington
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