Acupuncture and Chinese Herbal Medicine for Long COVID

Official title

Acupuncture for Long COVID - A Pragmatic Pilot Study

Overview

List of the Hypothesis: Primary hypothesis: A flexible acupuncture and Chinese herbal medicine protocol will be feasible, acceptable, and useful for the treatment of long COVID. Secondary hypothesis: Long COVID patients receiving acupuncture treatment or acupuncture treatment and Chinese herbal supplements over an 8-week period will see improvements in their symptoms, function, and quality of life measurements. Specific Aims of This Research (Purpose of the study): To study the feasibility, acceptability and utility of an acupuncture and Chinese herbal supplement treatment protocol for patients with long COVID and preliminarily assess the effects of treatment. Currently Available Research on This Subject: Studies indicate that acupuncture can effectively treat symptoms that are similar to those often seen in long COVID patients. Additionally, recent studies and clinical evidence suggest that there is substantial potential for acupuncture in the treatment of long COVID. Acupuncture may be beneficial because it can address many symptoms simultaneously with a single intervention, whereas symptom clusters can be difficult to manage with pharmaceuticals due to the need for multiple pharmaceutical agents. Summary of the research protocol/methodology: Five patients will receive acupuncture treatment, and five patients will receive acupuncture and Chinese herbal medicine. Each participant will receive 16 acupuncture treatments over the course of eight weeks (i.e., twice per week). Each treatment session will last for 30 minutes. Follow-up will occur at 12 weeks (i.e., four weeks after the final treatment session). Significance of this research to the health and welfare of general public: There is currently not a single, specific treatment for long COVID. If acupuncture treatment alone and/or acupuncture and Chinese herbal medicine combined are feasible, acceptable, and efficacious in the improvement of long COVID symptoms, it will offer patients additional treatment options, which may help some patients to avoid pharmaceutical treatment side effects or polypharmacy challenges.

Interventions

• Procedure Acupuncture
  The investigators have developed a list of core acupoints, which will be used by all clinicians for each specific TCM diagnosis pattern identified in each patient. Similarly, a list of common herbal formulas, that we will keep in stock based on the specific diagnosis patterns, has been developed. Clinicians will have the option of using additional acupoints as necessary and will be asked to record and explain any variations from the core protocol. 1. Residual Heat: LI-11, KI-6;Bai He Gu Jin Tan

Primary outcome measures

• Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID [Time frame: From enrollment to the final follow-up at 12 weeks]

Secondary outcome measures (12)

• Patient-Reported Acceptability of the Study Procedures and Treatments [Time frame: Week 12 (final follow-up).]
• Clinician-Reported Acceptability of the Study Protocol [Time frame: Week 12 (final follow-up).]
• Change in Health-Related Quality of Life Measured by PROMIS-29 v2.1 [Time frame: Baseline, Week 4, Week 8, and Week 12.]
• Change in Symptom Burden Measured by the Symptom Burden Questionnaire for Long COVID (SBQ™-LC) [Time frame: Baseline, Week 8, and Week 12.]
• Change in Whole Health Person Index (WHPI) [Time frame: Baseline, Week 8, and Week 12.]
• Change in Laboratory Biomarkers - Complete blood count [Time frame: Baseline and Week 8.]
• Incidence and Severity of Adverse Events Associated with Acupuncture and Herbal Medicine [Time frame: Throughout the 12-week study period]
• Change in Laboratory Biomarkers - Comprehensive metabolic panel [Time frame: Baseline and Week 8.]
• Change in Laboratory Biomarkers - C-reactive protein [Time frame: Baseline and Week 8.]
• Change in Laboratory Biomarkers - Erythrocyte sedimentation rate [Time frame: Baseline and Week 8.]
• Change in Laboratory Biomarkers - Tumor necrosis factor-alpha [Time frame: Baseline and Week 8.]
• Change in Laboratory Biomarkers - thyroid panel [Time frame: Baseline and Week 8.]

Eligibility criteria

Inclusion criteria

• 18 years of age or older

• We will include adults of any age in our study. Adults of all ages can experience long COVID symptoms, although it is more common in older adults

• Confirmed and documented COVID-19 illness (confirmed by healthcare provider or test; acceptable documentation includes but is not limited to a doctor's note or a photo of test result)
• COVID-19 illness is a necessary precursor to the development of long COVID

• Experiencing at least one of the following common long COVID symptoms for at least 4 weeks after confirmed COVID-19 illness:
• Fatigue or post-exertional malaise,
• Dyspnea, cough,
• Brain fog, sleep disturbance, depression, anxiety,
• Arthralgia, myalgia, or
• Constipation, diarrhea, stomach pain
• Over 200 different long COVID symptoms have been identified. The proposed study is a small pragmatic pilot study which only plans to enroll 10 participants. It is necessary to limit inclusion to some of the most common symptoms to ensure that the findings are broadly relevant across the long COVID patient population.

• The symptoms were not present prior to the confirmed COVID-19 illness

o If the symptoms were present prior to the confirmed COVID-19 illness, then they are most likely attributable to a cause other than long COVID

• Willingness to comply with the treatment schedule

o It is important that all those who qualify for the study are willing to comply with the protocol that is being adopted. If the patient is not willing to attend acupuncture treatment sessions or comply with the supplement schedule, then they may not be enrolled in the study.

• Ability to read and understand English o Informed consent will be in the English language. Inability to read and understand English will interfere with provision of informed consent. Moreover, compliance is a potential issue with herbal supplementation. Recruiting patients who are able to read and understand English instructions for supplement intake will help to improve compliance with the protocol.
• Ability to provide informed consent o It is important that participants are aware that they are required to provide written informed consent before they are allowed to participate. Some individuals who are eligible might be unwilling to sign the informed consent form.

Exclusion criteria

• • Under 18 years of age

• Pulmonary fibrosis or on continuous oxygen treatment
• Certain preexisting conditions:

• Diagnosed with Alzheimer's or demonstrating onset of dementia
• Uncontrolled hypertension, diabetes, or autoimmune conditions
• Other comorbid conditions that might imitate long COVID symptoms
• Undergoing cancer treatments
• Use of acupuncture or Chinese medicine in the past three months
• Involved in health-related litigation or legal claims
• Missing either baseline visit and deemed unlikely to comply with the study protocol
• Pregnant or breastfeeding or trying to get pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• SCUHS — Whittier

Identifiers

NCT: NCT07285707 · VINJ011 · VINJ011

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗