Not yet recruiting NCT07446712
Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early hyperbaric oxygen therapy (HBOT), Delayed hyperbaric oxygen therapy (HBOT).
- Who it may be relevant to
- Registry conditions: Chronic Pain, Complex Regional Pain Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome: a Randomised Controlled Trial
Overview
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
- Procedure Early hyperbaric oxygen therapy (HBOT)
The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment - Procedure Delayed hyperbaric oxygen therapy (HBOT)
The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.
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.]
- 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.]
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.]
- 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.]
- 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.]
- 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.]
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 2 centers
- University Hospital Ostrava — Ostrava
- Municipal Hospital Ostrava Fifejdy — Ostrava
Publications
- O'Connell NE, Wand BM, McAuley J, Marston L, Moseley GL. Interventions for treating pain and disability in adults with complex regional pain syndrome. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009416. doi: 10.1002/14651858.CD009416.pub2. PMID 23633371
- David Clark J, Tawfik VL, Tajerian M, Kingery WS. Autoinflammatory and autoimmune contributions to complex regional pain syndrome. Mol Pain. 2018 Jan-Dec;14:1744806918799127. doi: 10.1177/1744806918799127. Epub 2018 Aug 20. PMID 30124090
- Sarangi PP, Ward AJ, Smith EJ, Staddon GE, Atkins RM. Algodystrophy and osteoporosis after tibial fractures. J Bone Joint Surg Br. 1993 May;75(3):450-2. doi: 10.1302/0301-620X.75B3.8496220. PMID 8496220
- Olander JV, Marasa JC, Kimes RC, Johnston GM, Feder J. An assay measuring the stimulation of several types of bovine endothelial cells by growth factor(s) derived from cultured human tumor cells. In Vitro. 1982 Feb;18(2):99-107. doi: 10.1007/BF02796401. PMID 7084977
- Knudsen LF, Terkelsen AJ, Drummond PD, Birklein F. Complex regional pain syndrome: a focus on the autonomic nervous system. Clin Auton Res. 2019 Aug;29(4):457-467. doi: 10.1007/s10286-019-00612-0. Epub 2019 May 18. PMID 31104164
- Stanton-Hicks MD. CRPS: what's in a name? Taxonomy, epidemiology, neurologic, immune and autoimmune considerations. Reg Anesth Pain Med. 2019 Mar;44(3):376-387. doi: 10.1136/rapm-2018-100064. PMID 30777902
- Bruehl S. Complex regional pain syndrome. BMJ. 2015 Jul 29;351:h2730. doi: 10.1136/bmj.h2730. PMID 26224572
- El-Shewy KM, Kunbaz A, Gad MM, Al-Husseini MJ, Saad AM, Sammour YM, Abdel-Daim MM. Hyperbaric oxygen and aerobic exercise in the long-term treatment of fibromyalgia: A narrative review. Biomed Pharmacother. 2019 Jan;109:629-638. doi: 10.1016/j.biopha.2018.10.157. Epub 2018 Nov 3. PMID 30399600
Identifiers
NCT: NCT07446712 · HOTCom