Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome

Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome: a Randomised Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Complex Regional Pain Syndrome
• Intervention / Treatment: Procedure: Early hyperbaric oxygen therapy (HBOT); Procedure: Delayed hyperbaric oxygen therapy (HBOT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 +42059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 +42059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Ondřej Jor, MD, Ph.D., MBA
    • Ostrava, Moravian-Silesian Region, Czechia, 728 80
      • Municipal Hospital Ostrava Fifejdy
      • Contact: Michal Hájek, MD, Ph.D.; Phone Number: 2483 +42059619; Email: michal.hajek@mnof.cz
      • Principal Investigator: Michal Hájek, MD, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early group; Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0).	Procedure: Early hyperbaric oxygen therapy (HBOT); The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment
Experimental: Delayed group; 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); The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	The pain intensity will be measured by the Visual Analogue Scale (VAS 0-100).	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 pain responder status (≥30% reduction from baseline will be assessed.	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 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.	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 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.	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 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.	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.

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Ondřej Jor, MD, Ph.D., MBA, University Hospital Ostrava

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Complex Regional Pain Syndrome; Hyperbaric Oxygen Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Complex Regional Pain Syndromes
• Other Study ID Numbers: HOTCom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No