RecruitingNCT05417737

Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025

Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025. (EPOOzo)

Sponsor

Bernardino Clavo, MD, PhD

Enrollment

105 participants

Start Date

Jun 15, 2022

Study Type

OBSERVATIONAL

Conditions

Chemotherapy Induced Peripheral Neuropathy Chemotherapeutic Toxicity Radiation Toxicity Chronic Pain Delayed Wound Healing Refractory Pain

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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.
Patients have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study

Exclusion Criteria10

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.
Uncontrolled cancer disease requiring chemotherapy treatment.
Life expectancy \< 6 months
Contraindication or disability or to attend scheduled treatments.
Known allergy to ozone.
Pregnancy at the time of enrollment (for systemic ozone therapy). 10 Hemochromatosis (for systemic ozone therapy).
\. Known significant glucose-6-phosphate dehydrogenase deficiency (favism, acute hemolytic anemia) (for systemic ozone therapy).

Interventions

OTHEROzone therapy

Systemic 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.