Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

Centre Medicina Esportiva i Osteopatia, Spain

Status: Completed

Conditions: Ascorbic Acid; Adverse Effects; Oxidative Stress

Treatments: Dietary Supplement: 1gr. Vitamine C; Other: control group; Other: 1gr Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06102577

OMT and Vit.C

Details and patient eligibility

About

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].

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

1gr. Vitamine C

Experimental group

Description:

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

Treatment:

Dietary Supplement: 1gr. Vitamine C

1gr.Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: 1gr Placebo

control group

Sham Comparator group

Description:

control

Treatment:

Other: control group