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.
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.
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).
Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín, between January 2026 and December 2029, for symptomatic/palliative treatment with ozone therapy because standard treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.
Case-only
Prospective
Ozone Therapy
Procedure/SurgerySystemic (rectal, autohemotherapy) and/or local ozone administration (cutaneous, intravaginal, intravesical). Dosage, frequency, and duration will depend on the symptoms treated and clinical evolution. Usually planned 40 sessions over 4 months.
Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at the end of ozone therapy).
Self-reported evaluation of 5 physical and emotional items scored in five levels, plus a Visual Analog Scale (EQ-VAS) from 0 (worst health) to 100 (best health).
Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at 12 weeks after the end of ozone therapy).
Self-reported evaluation of 5 physical and emotional items scored in five levels, plus a Visual Analog Scale (EQ-VAS) from 0 (worst health) to 100 (best health).
Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at 24 weeks after the end of ozone therapy).
Self-reported evaluation of 5 physical and emotional items scored in five levels, plus a Visual Analog Scale (EQ-VAS) from 0 (worst health) to 100 (best health).
Change from Baseline in Anxiety and Depression Levels (HAD Scale) (at the end of ozone therapy).
Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21 for each subscale, where higher scores indicate worse anxiety or depression.
Change from Baseline in Anxiety and Depression Levels (HAD Scale) (at 12 weeks after the end of ozone therapy).
Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21 for each subscale, where higher scores indicate worse anxiety or depression.
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Bernardino Clavo, MD, PhD
Lead sponsor
Hospital Universitario de Gran Canaria Doctor Negrín
Sponsor institution
Hospital Universitario de Gran Canaria Doctor Negrín
Collaborator
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborator
Complejo Hospitalario Universitario Insular Materno Infantil
Collaborator
University of Las Palmas de Gran Canaria
Collaborator
Council of Gran Canaria
Collaborator
