An interventional study of Early hyperbaric oxygen therapy (HBOT) and Delayed hyperbaric oxygen therapy (HBOT) in Chronic Pain and Complex Regional Pain Syndrome, sponsored by University Hospital Ostrava. Recruiting at 2 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
The aim of the study is to investigate the efficacy of hyperbaric oxygen therapy as an adjunct in the management of severe complex regional pain syndrome.
Randomised controlled trial (RCT) with delayed start of therapy (delayed-start / wait-list). The intervention (early) group initiates therapy immediately after baseline (T0). The control (delayed) group initiates therapy only after the first follow-up (T1). The primary inter-group comparison is planned at time T1 (4-6 weeks after T0). In addition, for the delayed group, the post-treatment evaluation of T2 (4-6 weeks after T1) is supportive of the effect.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Diagnosis of CRPS Type I (without nerve injury)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0).
Procedure: Early hyperbaric oxygen therapy (HBOT)
Participants in the DELAYED group will receive usual care until T1 (4-6 weeks), after which they will cross over to receive the same HBOT regimen.
Procedure: Delayed hyperbaric oxygen therapy (HBOT)
The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment
The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.
Clinical functional test - active wrist range of motion
The active wrist range of motion (palmar and dorsal flexion) will be assessed as an indicator of swelling.
Time frame: The early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
Assessment of functional indicator - WHODAS 2.0
The primary outcome will be functional indicators, assessed through a combination of patient-reported disability measured by the WHODAS 2.0 (12-item) scale (0-100 points).
Time frame: The early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
Pain intensity
The pain intensity will be measured by the Visual Analogue Scale (VAS 0-100).
Time frame: he early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
Pain responder status
The pain responder status (≥30% reduction from baseline will be assessed.
Time frame: The early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
CRPS Severity Score
The Complex Regional Pain Syndrome (CRPS) Severity Score is a validated tool for quantifying the severity of Complex Regional Pain Syndrome by measuring 17 signs and symptoms, ranging from 0 to 17, where higher scores indicate greater severity.
Time frame: The early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
SF-12 PCS/MCS
The SF-12 is a 12-item, patient-reported survey that measures health-related quality of life, containing, among others the PCS and MCS components. Physical Component Summary (PCS) measures physical functioning, role limitations due to physical health, bodily pain, and general health perceptions. Mental Component Summary (MCS) measures vitality, social functioning, role limitations due to emotional problems, and general mental health.
Time frame: The early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
Patient Global Impression of Change
The Patient Global Impression of Change (PGIC) is a single-question, 7-point Likert scale (1=no improvement, 7=very much improved) that assesses a patient's self-reported belief regarding the efficacy of their treatment.
Time frame: The early group will receive 20-30 HBOT sessions over 4-6 week period and will be evaluated (T1) at baseline. The same evaluation T1 will be made for the second (delayed) group 4-6 weeks after baseline evaluation T0.
Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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