Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 20… (NCT07325851) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029.
Spain120 participantsStarted 2026-01-14
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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 5\. Patients must sign the specific Informed Consent for this study and for the ozone treatment.
Exclusion Criteria:
* 1\. Age \< 18 years old.
* 2\. Psychiatric illness or social situations that would limit compliance with study requirements.
Contraindication or disability to attend scheduled treatments.
* 3\. Contraindication or disability to attend scheduled treatments.
* 4\. Uncontrolled clinical conditions (e.g., severe heart failure, massive hemorrhage, status epilepticus).
* 5\. Life expectancy \< 6 months.
* 6\. Known allergy to ozone.
* 7\. Hemochromatosis (for systemic ozone treatment).
* 8\. Pregnancy (for systemic ozone treatment).
* 9\. Significant Glucose-6-Phosphate Dehydrogenase deficiency (Favism) (for systemic ozone treatment).
* 10\. Patients who do not meet the inclusion criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at the end of ozone therapy).
Timeframe: At the end of ozone therapy (approx. week 16).