Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBernardino Clavo, MD, PhD

About this trial

The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms who have been referred to the Dr. Negrín University Hospital Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between January 2026 and December 2029. Additionally, the study aims to evaluate several specific symptoms, hyperspectral and thermal images, non-invasive clinical parameters related to the Autonomic Nervous System (such as heart rate variability, electrochemical skin conductance, and vibration perception thresholds), oxidative stress and inflammatory parameters, and gut microbiota composition.

Eligibility criteria

Qualifiers

1. Adults ≥ 18 years old.

2. Patients referred to the Chronic Pain Unit of the Dr. Negrín University Hospital for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, has failed, has offered insufficient results, or is associated with high risk/morbidity.

3. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.

4. Patients have no contraindications for ozone treatment.

Disqualifiers

1. Age < 18 years old.

2. Psychiatric illness or social situations that would limit compliance with study requirements.

3. Contraindication or disability to attend scheduled treatments.

4. Uncontrolled clinical conditions (e.g., severe heart failure, massive hemorrhage, status epilepticus).

Trial design

Treatments tested in this trial

  • Ozone Therapy

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bernardino Clavo, MD, PhD

Lead sponsor

Dr. Negrin University Hospital

Sponsor institution

Dr. Negrin University Hospital

Collaborator

Fundación Canaria Instituto de Investigación Sanitaria de Canarias

Collaborator

Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI)

Collaborator

Instituto Universitario de Microelectrónica Aplicada de la Universidad de Las Palmas de Gran Canaria (IUMA-ULPGC)

Collaborator

Council of Gran Canaria

Collaborator