Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

Sponsor

Centre Medicina Esportiva i Osteopatia, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT06102577

Collaborator

(none)

Enrollment

Location

Arms

20.9

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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].

Condition or Disease	Intervention/Treatment	Phase
Adverse Effects Ascorbic Acid Oxidative Stress	Dietary Supplement: 1gr. Vitamine C Other: 1gr Placebo Other: control group	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jul 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1gr. Vitamine C

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

Dietary Supplement: 1gr. Vitamine C

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

Placebo Comparator: 1gr.Placebo

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

Other: 1gr Placebo

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

Sham Comparator: control group

control

Other: control group

control

Outcome Measures

Primary Outcome Measures

Probability of suffering systemic adverse effects [3 days]
Odds Ratio

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medicina Esportiva i Osteopatia	Mollet Del Vallès	Barcelona	Spain	08100

Sponsors and Collaborators

Centre Medicina Esportiva i Osteopatia, Spain

Investigators

Principal Investigator: Rafael Merino Solis, MD, CMosteoesport

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rafael Merino Solis, Dr. Rafael Merino Solis MD., Centre Medicina Esportiva i Osteopatia, Spain

ClinicalTrials.gov Identifier:

NCT06102577

Other Study ID Numbers:

OMT and Vit.C

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rafael Merino Solis, Dr. Rafael Merino Solis MD., Centre Medicina Esportiva i Osteopatia, Spain

Osteopathic Medicine

Manipulation, Osteopathic

Additional relevant MeSH terms:

Iatrogenic Disease

Study Results

No Results Posted as of Oct 31, 2023