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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06102577
Enrollment
99
Registered
2023-10-26
Start date
2021-11-01
Completion date
2023-07-30
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effects, Ascorbic Acid, Oxidative Stress

Keywords

Osteopathic Medicine, Manipulation, Osteopathic, Adverse effects, Vitamine C, Ascorbic Acid, Oxidative Stress

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.

Interventions

DIETARY_SUPPLEMENT1gr. Vitamine C

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

OTHER1gr Placebo

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

OTHERcontrol group

control

Sponsors

Centre Medicina Esportiva i Osteopatia, Spain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Probability of suffering systemic adverse effects3 daysOdds Ratio

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026