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
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