Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome

NCT07446712 | Not Yet Recruiting

• 1 other identifier: HOTCom
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Complex Regional Pain Syndrome

Keywords

Complex Regional Pain Syndrome; Chronic Pain; Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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).

  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 (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Early group

EXPERIMENTAL

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

Procedure: Early hyperbaric oxygen therapy (HBOT)

Delayed group

EXPERIMENTAL

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.

Procedure: Delayed hyperbaric oxygen therapy (HBOT)

Interventions

Early hyperbaric oxygen therapy (HBOT) PROCEDURE

The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment

Early group

Delayed hyperbaric oxygen therapy (HBOT) PROCEDURE

The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.

Delayed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of CRPS Type I (without nerve injury)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (2)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Municipal Hospital Ostrava Fifejdy

Ostrava, Moravian-Silesian Region, 728 80, Czechia

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bruehl S. Complex regional pain syndrome. BMJ. 2015 Jul 29;351:h2730. doi: 10.1136/bmj.h2730.

  PMID: 26224572 BACKGROUND

• 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 BACKGROUND

• Tsang A, Von Korff M, Lee S, Alonso J, Karam E, Angermeyer MC, Borges GL, Bromet EJ, Demytteneare K, de Girolamo G, de Graaf R, Gureje O, Lepine JP, Haro JM, Levinson D, Oakley Browne MA, Posada-Villa J, Seedat S, Watanabe M. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain. 2008 Oct;9(10):883-91. doi: 10.1016/j.jpain.2008.05.005. Epub 2008 Jul 7.

  PMID: 18602869 BACKGROUND

• Elliott AM, Smith BH, Penny KI, Smith WC, Chambers WA. The epidemiology of chronic pain in the community. Lancet. 1999 Oct 9;354(9186):1248-52. doi: 10.1016/s0140-6736(99)03057-3.

  PMID: 10520633 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Ondřej Jor, MD, Ph.D., MBA

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

+42059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)