Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

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

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].

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Adverse Effects; Ascorbic Acid
• Intervention / Treatment: Dietary supplement: 1gr. Vitamine C; Other: 1gr Placebo; Other: control group

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mollet Del Vallès, Barcelona, Spain, 08100
      • Medicina Esportiva i Osteopatia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Medicina Esportiva i Osteopatia, Spain
• Investigators: Principal Investigator: Rafael Merino Solis, MD, CMosteoesport

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 21, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Oxidative Stress; Ascorbic Acid; Osteopathic Medicine; Adverse effects; Manipulation, Osteopathic; Vitamine C
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Drug-Related Side Effects and Adverse Reactions; Iatrogenic Disease
• Other Study ID Numbers: OMT and Vit.C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No