Clinical trial NCT06102577: Systemic Adverse Effects After Osteopathic Treatment and Vitamin C
Official title: Systemic Adverse Effects After Osteopathic Treatment and the Preventive Effect of Vitamin C: Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effects
Ascorbic Acid
Oxidative Stress
Keywords: Osteopathic Medicine
Manipulation, Osteopathic
Adverse effects
Vitamine C
Ascorbic Acid
Oxidative Stress
Lead sponsor: Centre Medicina Esportiva i Osteopatia, Spain
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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\].

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Probability of suffering systemic adverse effects
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mollet Del Vallès
country: Spain
facility: Medicina Esportiva i Osteopatia
state: Barcelona
Study officials:
affiliation: CMosteoesport
name: Rafael Merino Solis, MD
role: PRINCIPAL_INVESTIGATOR
References: