Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Hyperbaric oxygen therapy for severe CRPS

Official title: Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome: a Randomised Controlled Trial

Run by University Hospital Ostrava · NCT07446712 · Data updated 2026-11-12

This trial tests whether adding hyperbaric oxygen therapy helps people with severe complex regional pain syndrome compared with a delayed-start approach.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversity Hospital Ostrava
Academic / other
Drugs / interventionsdoxorubicin
Locations2 sites (Ostrava, Moravian-Silesian Region and 1 other locations)
StatusRecruiting
StartedApril 1, 2026
Main results expectedApril 2028
Study endsApril 2029
Registry record updatedAugust 25, 2026
Trial IDNCT07446712 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with CRPS Type I (without nerve injury) who meet HBOT safety criteria and can provide informed consent.

Probably not a fit

Patients with contraindications to HBOT or those unlikely to benefit from this modality may not experience improvement.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, delayed-start study compares immediate versus delayed hyperbaric oxygen therapy in adults with CRPS Type I without nerve injury. The primary comparison occurs 4-6 weeks after baseline, with a secondary assessment after the delayed group's treatment. The study uses an early-treatment group and a wait-list control group to determine if HBOT provides additional benefit when added to standard care. Eligible participants must have CRPS Type I and meet safety criteria for HBOT. The trial is conducted at two hospitals in Ostrava, Czech Republic, led by University Hospital Ostrava with collaboration from Municipal Hospital Ostrava Fifejdy.

Why it matters

Potential benefit: If successful, patients may experience reduced pain and improved function from hyperbaric oxygen therapy.

How similar studies have gone: Previous studies of HBOT for CRPS have shown mixed but promising signals in some patients, though results vary by study design and population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

\- Diagnosis of CRPS Type I (without nerve injury)

Exclusion Criteria:

* HBOT contraindications (pregnancy; use of bleomycin, cisplatin, disulfiram, and doxorubicin; middle ear surgery; untreated pneumothorax or pneumomediastinum; ongoing acute infection; severe decompensation of organ functions or organ failure, severe claustrophobia)
* Inability to sign the consent form

Where it's running

  • University Hospital Ostrava
    Ostrava, Moravian-Silesian Region, Czechia
    Recruiting
  • Municipal Hospital Ostrava Fifejdy
    Ostrava, Moravian-Silesian Region, Czechia
    Recruiting

Study contacts

  • Principal investigator: Michal Hájek, MD, Ph.D., — Municipal Hospital Ostrava Fifejdy
  • Study coordinator: Michal Hájek, MD, Ph.D.
  • Email: michal.hajek@mnof.cz
  • Phone: +42059619

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.