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临床试验/NCT06102577
NCT06102577已完成不适用

Systemic Adverse Effects After Osteopathic Treatment and the Preventive Effect of Vitamin C: Triple-blind Clinical Trial

Centre Medicina Esportiva i Osteopatia, Spain2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
2
主要终点
Probability of suffering systemic adverse effects

研究概览

简要总结

The goal of this triple-blind randomized clinical trial is to learn about systemic adverse effects in first visit patients who attend an osteopathic medicine center in Barcelona. The main question it aims to answer are:

• Check if there is a relationship between taking vitamin C and the reduction in the appearance of systemic adverse effects after osteopathic treatment (24-72 hours) First-visit patients, at the end of treatment, are asked to enter the study. If they accept, they are administered 1g. of vitamin C, or 1g. placebo or nothing.

If there is a comparison group: Researchers will compare placebo group, control group and intervention group to see if there is a relationship between taking vitamin C and the appearance of systemic adverse effects].

详细描述

Introduction Systemic adverse effects (SAE) after osteopathic treatment are rarely reported in the scientific literature. There is a consensus in the scientific literature that these adverse effects occur with a certain frequency, without it being clear what the pathophysiology of such effects is. The relationship between free radicals and central sensitization to pain is increasingly evident. Vitamin C is known as a good electron receptor that is used by the body's antioxidant systems to reduce and also has anti-inflammatory properties. The brain has deficiencies in antioxidant systems and vitamin C has a very important role in the control of oxidative stress.

Objective Check if there is a relationship between taking vitamin C and the reduction in the appearance of systemic adverse effects after osteopathic treatment (24-72 hours).

Design Triple-blind randomized clinical trial, where one group was given 1g of vitamin C, another group was given 1g of placebo and the third group was given nothing. From April 1 to May 30, 2022, patients without food allergies or intolerances were recruited. The patients were randomly assigned to the study groups and neither the patient, nor the therapist, nor the person in charge of collecting the data was aware of which group each patient belonged to. Adverse reactions were classified in relation to pain and fatigue. Data collection was carried out through WhatsApp messages to the patients 72 hours after receiving the treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The patient is randomized at the end of the treatment and the person in charge of collecting the data does not know which group each patient belongs to.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • first-visit patients
  • of legal age,
  • without food allergies or intelorenacies
  • the ability to receive and send messages via WhatsApp.

排除标准

  • 未提供

研究组 & 干预措施

1gr. Vitamine C

Experimental

Take 1g. of vitamin C at the end of an osteopathic manual treatment

干预措施: 1gr. Vitamine C (Dietary Supplement)

1gr.Placebo

Placebo Comparator

Take 1g. of placebo at the end of an osteopathic manual treatment

干预措施: 1gr Placebo (Other)

control group

Sham Comparator

control

干预措施: control group (Other)

结局指标

主要结局

Probability of suffering systemic adverse effects

时间窗: 3 days

Odds Ratio

次要结局

未报告次要终点

研究者

发起方
Centre Medicina Esportiva i Osteopatia, Spain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rafael Merino Solis

Dr. Rafael Merino Solis MD.

Centre Medicina Esportiva i Osteopatia, Spain

研究点 (2)

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