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NCT Number: NCT07446712

Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome

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.

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Key information

Conditions

Chronic Pain Autonomic Nervous System Diseases Complex Regional Pain Syndrome Complex Regional Pain Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Municipal Hospital Ostrava Fifejdy, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early hyperbaric oxygen therapy (HBOT)

Procedure

The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment

Delayed hyperbaric oxygen therapy (HBOT)

Procedure

The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.

Primary outcomes

  1. Clinical functional test - active wrist range of motion

    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.

    The active wrist range of motion (palmar and dorsal flexion) will be assessed as an indicator of swelling.

  2. Assessment of functional indicator - WHODAS 2.0

    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.

    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).

Secondary outcomes

  1. Pain intensity

    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.

    The pain intensity will be measured by the Visual Analogue Scale (VAS 0-100).

  2. Pain responder status

    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.

    The pain responder status (≥30% reduction from baseline will be assessed.

  3. CRPS Severity Score

    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.

    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.

  4. SF-12 PCS/MCS

    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.

    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.

  5. Patient Global Impression of Change

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

+42059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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