Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
Early hyperbaric oxygen therapy (HBOT)
Procedure/SurgeryThe hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment
Delayed hyperbaric oxygen therapy (HBOT)
Procedure/SurgeryThe hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Early groupExperimental treatment 1 intervention
Group B: Delayed groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 T0.2
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.Secondary outcomes
1
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 T0.2
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 T0.3
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 T0.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Ostrava
Lead sponsor
Municipal Hospital Ostrava Fifejdy
Collaborator
Source ClinicalTrials.gov