Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

Study Overview
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Brief Summary
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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].

Detailed Description
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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.

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

Conditions
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Adverse Effects, Ascorbic Acid, Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: 1gr. Vitamine C
* Other: 1gr Placebo
* Other: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first-visit patients of legal age, without food allergies or intelorenacies the ability to receive and send messages via WhatsApp. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1gr. Vitamine C<br>Take 1g. of vitamin C at the end of an osteopathic manual treatment | Dietary Supplement: 1gr. Vitamine C<br>* Take 1g. of vitamin C at the end of an osteopathic manual treatment<br>|
| Placebo Comparator: 1gr.Placebo<br>Take 1g. of placebo at the end of an osteopathic manual treatment | Other: 1gr Placebo<br>* ake 1g. of placebo at the end of an osteopathic manual treatment<br>|
| Sham Comparator: control group<br>control | Other: control group<br>* control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of suffering systemic adverse effects | Odds Ratio | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Medicine, Manipulation, Osteopathic, Adverse effects, Vitamine C, Ascorbic Acid, Oxidative Stress