Determination and Characterization of Persistent Musculoskeletal Pain in Covid-19 Patients in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Quality of life (QoL)
研究概览
简要总结
Justification: among the sequelae of Covid-19 in clinical practice we frequently find persistent neuromusculoskeletal pain. Prevalence data and the underlying mechanisms of such pain are very limited in the scientific literature. Therefore, with this research we will try to answer these questions.
Main objective: to determine and characterize persistent musculoskeletal pain in Covid-19 patients.
Method: two phases. First, a descriptive cross-sectional study will be carried out to estimate the prevalence of Long Covid Pain (LCP). Second phase, a case-control study will be carried out using the sample obtained in the first phase as the population. The sample will be divided into two groups: post-Covid-19 patients with LCP and post-Covid-19 patients without persistent pain (control group). The two groups will be matched according to sex, age and level of severity of the pathology.
An assessment and comparison between groups will be made of the following variables: central sensitization, healthy physical condition and blood test values, which will be evaluated by means of physical examination, questionnaires and laboratory tests.
Applicability of the results: this is a pioneering project at the national level, which would determine more reliably the prevalence of LCP in postcovid and could be a first step in the search for the best therapeutic strategies for these patients. This would help to improve the quality of life of these patients and to better manage the social and healthcare resources used in their treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have had Covid-19, with a confirmatory PCR+ test or positive antigen test and recorded in their primary care medical record.
- •Subjects between 18-70 years old.
- •Musculoskeletal pain of more than 12 weeks of evolution since the beginning of the infection.
- •Agree to participate in the study and sign the informed consent form.
排除标准
- •History of chronic musculoskeletal pain of more than 12 weeks of evolution prior to Covid-
- •History of diagnosed major depression.
- •Having a diagnosis of fibromyalgia prior to Covid-19 infection.
- •Pregnancy.
- •Pain of oncologic origin.
- •Fracture or surgical intervention on the spine in the last year.
- •Bladder or bowel incontinence.
- •Saddle anesthesia.
结局指标
主要结局
Quality of life (QoL)
时间窗: 1 day
EQ-5D questionnaire (Qualitave of Life 5 Dimension): The EQ-5D-3L is a brief multi-attribute health status measure composed of five questions with Likert response options (descriptive system) and a visual analogue scale (EQ-VAS). The descriptive system covers five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with three levels of severity in each dimension (no problems, some problems, and extreme problems).
次要结局
- Areas of pain(1 day)
- Handgrip Strength assessment(1 day)
- Pain Intensity(1 day)
- Quantitative sensory tests(1 day)
研究者
Laura Barrero Santiago
Phd Candidate
University of Valladolid