Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome

University Hospital Ostrava

Status: Not yet enrolling

Conditions: Chronic Pain; Complex Regional Pain Syndrome

Treatments: Procedure: Delayed hyperbaric oxygen therapy (HBOT); Procedure: Early hyperbaric oxygen therapy (HBOT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07446712

HOTCom

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Early group

Experimental group

Description:

Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0).

Treatment:

Procedure: Early hyperbaric oxygen therapy (HBOT)

Delayed group

Experimental group

Description:

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.

Treatment:

Procedure: Delayed hyperbaric oxygen therapy (HBOT)