Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 723
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Care was provided by chiropractors,
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chiropractic patients active when lockdown was declared, over the age of 14
排除标准
- •new patients in the clinic, patients with no current pain at the time of the trial
研究组 & 干预措施
Group Control
Patients having no access to chiropractic treatment during the trial
Group Chiropractic Care one session
Patients having access to in-person chiropractic treatment once during the trial
干预措施: Chiropractic care (one visit) (Other)
Group Chiropractic Care multiple sessions
Patients having access to in-person chiropractic treatment more than once during the trial
干预措施: Chiropractic care (more than one visit) (Other)
结局指标
主要结局
Pain intensity
时间窗: 14 days
Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Pain frequency
时间窗: 14 days
Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Pain evolution
时间窗: 14 days
Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
Pain interference
时间窗: 14 days
Validated subscale form the Brief Pain Inventory, 6 categories from 0 to 10 each, the lower, the better outcomes, out of a minimal of 0 and total of 60.
次要结局
- Pain Catastrophizing Scale(14 days)
- Tampa Scale Kinesiophobia(14 days)
- General Anxiety Disorder scale(14 days)
- Intolerance of Uncertainty Scale(14 days)
- General Self-Efficacy scale(14 days)
- Fear of Illness and Virus Evaluation(14 days)