Effect of Stellate Ganglion Block Treatment on Long COVID Symptoms: A Single-Blind, Single-Center Randomized Controlled Trial (STAR-CO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post-COVID-19 Functional Status Scale (PCFS)
研究概览
简要总结
This single-center, randomized, controlled, single-blind clinical trial evaluates whether a stellate ganglion block (SGB) using bupivacaine can improve persistent symptoms in adults with long COVID. Participants are assigned in a 1:1 ratio to receive either an ultrasound-guided right-sided SGB or a placebo saline injection delivered to the sternocleidomastoid muscle. After the intervention, participants are followed for 26 weeks with scheduled evaluations that include symptom questionnaires and functional tests.
The study assesses changes in functional status, fatigue, cognitive complaints, quality of life, dyspnea, lower-limb endurance, and orthostatic tolerance over time. Safety is monitored throughout all follow-up visits. Approximately 40 participants meeting predefined eligibility criteria will be enrolled. This trial seeks to determine whether a single stellate ganglion block has an effect on persistent long-COVID symptoms compared with placebo.The results will help determine the therapeutic value of SGB in the management of long COVID and inform future research and clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The statistician performing the data analysis will also be masked to group assignment.
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
- •Adults aged 18 years and older
- •Positive COVID-19 test confirmed by RT-PCR, antibody test, or antigen test at least 3 months prior to randomization, OR presumed COVID-19 evaluated by the site investigator (no positive test required) with an acute illness occurring after October 15, 2019 and at least 3 months prior to randomization.
- •Persistent symptoms ≥12 weeks after onset of acute COVID-19 AND symptoms lasting at least 2 months. The onset date is defined as the earliest of: date of first positive test, date of first symptoms
- •Post-COVID Functional Status Scale score ≥
- •Persistent dyspnea ≥2/4 on the mMRC scale at least 12 weeks post-infection.
- •Persistent COVID-19-related symptoms at the time of randomization.
- •If taking medications for fatigue or cognition (e.g., sildenafil, modafinil, armodafinil, guanfacine, N-acetylcysteine, stimulants for ADHD), these must have been initiated and stable for ≥4 weeks prior to randomization. Participants are asked not to stop or alter these medications during the study if possible.
- •Able and willing to provide written informed consent.
- •Able to read and understand French.
排除标准
- •Prior diagnosis of myalgic encephalomyelitis (ME) or fibromyalgia
- •Being on sick leave or disability at the time of the original acute COVID-19 infection.
- •Pregnancy or breastfeeding.
- •Myocardial infarction within the last 12 weeks.
- •Use of anticoagulant therapy.
- •Glaucoma.
- •Emphysema requiring home oxygen.
- •Cardiac conduction abnormalities.
- •Known hypersensitivity to bupivacaine.
- •Previous stellate ganglion block (SGB) procedure.
- •Any condition that, in the judgment of the medical investigator, makes the patient not a candidate for the proposed treatment.
研究组 & 干预措施
Stellate Ganglion Block with Bupivacaine
Participant receives a right-sided stellate ganglion block under ultrasound guidance, using bupivacaine, performed by an anesthesiologist.
干预措施: Stellate Ganglion Block (Bupivacaine) (Procedure)
Placebo Neck Injection
Participant receives a saline injection into the sternocleidomastoid muscle under the same conditions.
干预措施: placebo saline injection (Procedure)
结局指标
主要结局
Post-COVID-19 Functional Status Scale (PCFS)
时间窗: 4 weeks after the intervention
The PCFS measures limitations in daily functioning related to persistent post-COVID-19 symptoms. Scores range from 0 (no functional limitation) to 4 (severe functional limitation). Assesses changes in functional status over time.
Fatigue Severity Scale (FSS)
时间窗: 4 weeks after the intervention
The FSS is a validated 9-item questionnaire assessing the impact of fatigue on daily activities, motivation, and functioning. Each item is scored from 1 to 7; higher scores indicate greater fatigue severity. Clinically significant change is defined as ≥0.45 points.
Brain Fog Scale (BFS)
时间窗: 4 weeks after the intervention
The BFS is a 23-item questionnaire evaluating cognitive symptoms associated with Long COVID, including mental fatigue, cognitive clarity, logical thinking, and concentration. Total scores range from 0 to 92, with higher scores indicating more severe cognitive impairment.
次要结局
- Health-Related Quality of Life (SF-36)(4 weeks after the intervention)
- Dyspnea Severity (mMRC Scale)(4 weeks after the intervention)
- Lower-Limb Muscle Endurance (1-Minute Sit-to-Stand Test)(4 weeks after the intervention)
- Orthostatic Intolerance (NASA Lean Test)(4 weeks after the intervention)
研究者
Marie-Claude Lehoux
Principal Investigator
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec