Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome
ID: NCT07446712
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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.
Read Full Scientific Objectives & Methods
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.
The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment
The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.
Treatment Arms Description
Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0).
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.
- \- Diagnosis of CRPS Type I (without nerve injury)
- 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
Primary Outcome Measures
- 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.
- 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).
View Secondary Outcome Measures (5)
- 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).
- 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.
- 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.
- 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.
- 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.
This trial is recruiting at 2 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 2 Facilities & Contact Sites
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View Official Medical/Scientific Title
Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome: a Randomised Controlled Trial