Acupuncture for Long COVID - A Pragmatic Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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
结局指标
主要结局
Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID
时间窗: From enrollment to the final follow-up at 12 weeks
Feasibility will be measured through a feasibility assessment questionnaire which will evaluate recruitment, retention, and adherence metrics across the 12-week intervention and the final follow-up. Feasibility indicators will be summarized as proportions and descriptive statistics to evaluate the practicality of the study procedures and protocol implementation.
次要结局
- Patient-Reported Acceptability of the Study Procedures and Treatments(Week 12 (final follow-up).)
- Clinician-Reported Acceptability of the Study Protocol(Week 12 (final follow-up).)
- Change in Health-Related Quality of Life Measured by PROMIS-29 v2.1(Baseline, Week 4, Week 8, and Week 12.)
- Change in Symptom Burden Measured by the Symptom Burden Questionnaire for Long COVID (SBQ™-LC)(Baseline, Week 8, and Week 12.)
- Change in Whole Health Person Index (WHPI)(Baseline, Week 8, and Week 12.)
- Change in Laboratory Biomarkers - Complete blood count(Baseline and Week 8.)
- Incidence and Severity of Adverse Events Associated with Acupuncture and Herbal Medicine(Throughout the 12-week study period)
- Change in Laboratory Biomarkers - Comprehensive metabolic panel(Baseline and Week 8.)
- Change in Laboratory Biomarkers - C-reactive protein(Baseline and Week 8.)
- Change in Laboratory Biomarkers - Erythrocyte sedimentation rate(Baseline and Week 8.)
- Change in Laboratory Biomarkers - Tumor necrosis factor-alpha(Baseline and Week 8.)
- Change in Laboratory Biomarkers - thyroid panel(Baseline and Week 8.)
- Change in Laboratory Biomarkers - Vitamin D levels.(Baseline and Week 8.)