Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 20… (NCT05417737) | Clinical Trial Compass
RecruitingNot Applicable
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025
Spain105 participantsStarted 2022-06-15
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults \> = 18 years old.
✓. Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. NegrÃn 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 criteria
✕. 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.
What they're measuring
1
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)