Chronic Pain, Complex Regional Pain Syndrome
Conditions
Keywords
Complex Regional Pain Syndrome, Chronic Pain, Hyperbaric Oxygen Therapy
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREEarly hyperbaric oxygen therapy (HBOT)
The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment
PROCEDUREDelayed hyperbaric oxygen therapy (HBOT)
The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.
Sponsors
University Hospital Ostrava
Municipal Hospital Ostrava Fifejdy
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will use a two-period, delayed-start (cross-over) randomization design, in which participants are randomly allocated in a 1:1 ratio to receive either immediate HBOT (EARLY group) or delayed HBOT (DELAYED group). Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0), whereas 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical functional test - active wrist range of motion | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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 | 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 | 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 | 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 | 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. |
Countries
Czechia
Contacts
CONTACTMichal Hájek, MD, Ph.D.
PRINCIPAL_INVESTIGATORMichal Hájek, MD, Ph.D.,
Municipal Hospital Ostrava Fifejdy
Outcome results
None listed