Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

NCT ID: NCT06102577

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-07-30

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.

Conditions

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Adverse Effects Ascorbic Acid Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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1gr. Vitamine C

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

Group Type EXPERIMENTAL

1gr. Vitamine C

Intervention Type DIETARY_SUPPLEMENT

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

1gr.Placebo

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

Group Type PLACEBO_COMPARATOR

1gr Placebo

Intervention Type OTHER

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

control group

control

Group Type SHAM_COMPARATOR

control group

Intervention Type OTHER

control

Interventions

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1gr. Vitamine C

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

Intervention Type DIETARY_SUPPLEMENT

1gr Placebo

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

Intervention Type OTHER

control group

control

Intervention Type OTHER

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Medicina Esportiva i Osteopatia, Spain

OTHER

Sponsor Role lead

Responsible Party

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Rafael Merino Solis

Dr. Rafael Merino Solis MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Merino Solis, MD

Role: PRINCIPAL_INVESTIGATOR

CMosteoesport

Locations

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Medicina Esportiva i Osteopatia

Mollet del Vallès, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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OMT and Vit.C

Identifier Type: -

Identifier Source: org_study_id

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