Early Effects of a Pain Informed Movement Program in Patients With Post COVID-19 Condition Experiencing Persistent Pain: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in catastrophization
研究概览
简要总结
Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of Pain Informed Movement program in patients with post COVID-19 condition experiencing persistent pain. Through the implementation of this program, the investigators seek to determine whether such intervention can offer significant improvements in reducing pain intensity and interference, catastrophizing, kinesiophobia, and functionality of affected patients.
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 (Outcomes Assessor)
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
- •Patients of both sexes.
- •Agreed to participate.
- •Post COVID-19 condition patients meeting the WHO definition for this disease.
- •Patients with moderate or severe pain were included, the cut-off point on the Visual Analogical Scale (VAS) being pain greater than or equal to 3.5 cm.
排除标准
- •Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
- •Cognitive impairment that prevented them from understanding and answering the questionnaires.
- •Patients suffering from a reinfection with SARS-CoV-
- •Patients with a history of severe or critical COVID-19 disease severity.
- •Patients who had pre-existing chronic pain according to the current IASP definition.
- •Patients participating in other studies.
研究组 & 干预措施
Standard medical care and leaflet education
干预措施: Standard medical care and leaflet education (Other)
Pain Informed Movement program
干预措施: Pain Informed Movement program (Other)
结局指标
主要结局
Changes in catastrophization
时间窗: Baseline and at 8 weeks at the end of the intervention
To evaluate the phenomenon of catastrophizing, the Pain Catastrophizing Scale (PCS) was applied. This instrument consists of 13 statements structured on a 5-point Likert scale ranging from 0 (at no time) to 4 (at all times). The PCS breaks down catastrophizing into three components: feelings of helplessness, magnification of difficulties, and rumination about pain. Each of the items describes different thoughts and emotions that people may experience when in pain. The final score is obtained by summing the scores of all the items, resulting in a score ranging from 0 to 52, with higher scores indicating a higher level of catastrophizing.
Changes in functionality
时间窗: Baseline and at 8 weeks at the end of the intervention
Functionality was assessed using the WHODAS 2.0 tool (World Health Organization Disability Assessment Schedule). It consists in 36 items assessing six main areas of functional ability. This questionnaire uses a 5-point Likert scale for respondents to rate their level of difficulty in six main subscales: Cognition, Mobility, Self-Care, Interpersonal Relationships, Home Life and Community Involvement. Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do). The scores obtained in each area are added to obtain a total score that shows the degree of functional limitation.
Changes in pain intensity and pain interference
时间窗: Baseline and at 8 weeks at the end of the intervention
Pain intensity and interference were quantified using the Brief Pain Inventory (BPI). The section intended to measure pain intensity on the BPI comprises four items, while the section related to pain interference includes seven items. In the intensity section, responses range on a scale from 0 (no pain) to 10 (maximum pain), while in the interference section, responses range from 0 (no interference) to 10 (total interference). To calculate the severity and interference index, the values of the corresponding items are averaged, obtaining values ranging from 0 to 10, with a higher score indicating greater pain intensity and interference. The BPI has been validated as a reliable and valid tool to evaluate these aspects of pain.
Changes in kinesiophobia
时间窗: Baseline and at 8 weeks at the end of the intervention
The Tampa Kinesiophobia Scale (TSK) was used to quantify apprehension related to physical activity and the fear of injury (or re-injury). This scale is composed of 11 statements, which are assigned a score on a 4-point scale (1-4). Total scores vary between 11 and 44 points, with higher values being indicative of greater fear of movement and the possibility of (re)injury.
次要结局
未报告次要终点
研究者
Marie Carmen Valenza
Principal Investigator
Universidad de Granada