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 HUGCDN Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between June-2022 and December-2025
Adults > = 18 years old.
Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.
After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.
Patients have no contraindications for ozone treatment.
Age < 18 years old.
Psychiatric illness or social situations that would limit compliance with study requirements.
Those who are incapable to fill in the scales used to measure variables.
Hemodynamically or clinically unstable patients or uncontrolled severe illness.
Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín 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
Other interventionSystemic and/or local ozone administration. Dosage, frequency, and duration of ozone treatment will depend on the treated symptom and clinical evolution. Usually planned 40 sessions.
Change from Baseline in the health-related quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Change from Baseline in Levels of anxiety and depression according to the hospital anxiety/depression scale (at the end of ozone therapy)
HAD scale is a self-administered questionnaire which assesses 14 items pertaining to symptoms of anxiety (seven) and depression (seven) experienced by patients. Each item is scored from 0 (better, no alteration) to 3 (worse level of alteration). For each symptom, overall score is from 0 (better, no anxiety or depression) to 21 (worse, very severe anxiety or depression).
Change from Baseline in pain score according to the visual analog scale (VAS) (at the end of ozone therapy)
Self-reported evaluation of the severity of pain according to the VAS, scored from 0 ("No pain") to 10 ("Pain as bad as you can imagine")
Change from Baseline in the grade of toxicity secondary to cancer-treatment (if applicable) according to the CTCAE v5.0 scale (at the end of ozone therapy)
Grade of toxicity secondary to cancer-treatment according to the CTCAE v5.0 (Common Terminology Criteria for Adverse Events from the National Cancer Institute) scale. Each toxicity is usually scored from 0 (asymptomatic or mild symptoms) to 5 (death).
Changes from Baseline in requirements of invasive procedures (surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management (at the end of ozone therapy)
Number of invasive procedures (surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management.
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Bernardino Clavo, MD, PhD
Lead sponsor
Dr. Negrin University Hospital
Sponsor institution
Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FIISC)
Collaborator
Servicio Canario de Salud
Collaborator
Council of Gran Canaria
Collaborator
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
Collaborator
Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna
Collaborator
