Chronic PainNCT07446712
Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome
A study testing Early hyperbaric oxygen therapy (HBOT) and Delayed hyperbaric oxygen therapy (HBOT) in people with Chronic Pain and Complex Regional Pain Syndrome, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Complex Regional Pain Syndrome
- What is being tested?
- Early hyperbaric oxygen therapy (HBOT) and Delayed hyperbaric oxygen therapy (HBOT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CRPS Type I (without nerve injury)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, +42059737 ext. 2587, jiri.hyncica@fno.cz
Ondřej Jor, MD, Ph.D., MBA
- Recruiting
Municipal Hospital Ostrava Fifejdy
Ostrava, Moravian-Silesian Region, 728 80
Michal Hájek, MD, Ph.D., +42059619 ext. 2483, michal.hajek@mnof.cz
Michal Hájek, MD, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Complex Regional Pain Syndrome
- Being tested
- Early hyperbaric oxygen therapy (HBOT), Delayed hyperbaric oxygen therapy (HBOT)
- Keywords
- Complex Regional Pain Syndrome, Chronic Pain, Hyperbaric Oxygen Therapy
- Medical subject headings
- Chronic Pain, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early hyperbaric oxygen therapy (HBOT)Procedure or surgery
The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment
Delayed hyperbaric oxygen therapy (HBOT)Procedure or surgery
The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment.
| Study group | Role | What they receive |
|---|---|---|
| Early group | Experimental | Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0). Receives: 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. Receives: Procedure: Delayed hyperbaric oxygen therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
The pain intensity will be measured by the Visual Analogue Scale (VAS 0-100).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Municipal Hospital Ostrava Fifejdy
- Responsible party
- Sponsor
- Investigators
- Michal Hájek, MD, Ph.D.,, Principal investigator, Municipal Hospital Ostrava Fifejdy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446712
- Sponsor's protocol ID
- HOTCom
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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.
PubMed 23633371David 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.
PubMed 30124090Sarangi 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.
PubMed 8496220Olander 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.
PubMed 7084977Knudsen 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.
PubMed 31104164Stanton-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.
PubMed 30777902Bruehl S. Complex regional pain syndrome. BMJ. 2015 Jul 29;351:h2730. doi: 10.1136/bmj.h2730.
PubMed 26224572El-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.
PubMed 30399600Tsang 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.
PubMed 18602869Elliott 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.
PubMed 10520633
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07446712
- Acronym / sponsor ID
- HOTCom
- Conditions
- Chronic Pain, Complex Regional Pain Syndrome
- Keywords
- Complex Regional Pain Syndrome, Chronic Pain, Hyperbaric Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Municipal Hospital Ostrava Fifejdy
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early group | Experimental | Procedure: Early hyperbaric oxygen therapy (HBOT)Participants in the EARLY group will undergo HBOT immediately after baseline assessment (T0). |
| Delayed group | Experimental | Procedure: Delayed hyperbaric oxygen therapy (HBOT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of CRPS Type I (without nerve injury)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early hyperbaric oxygen therapy (HBOT)The hyperbaric oxygen therapy (HBOT) will be initiated immediately after enrolment | Procedure or surgery | Early group |
| Delayed hyperbaric oxygen therapy (HBOT)The hyperbaric oxygen therapy (HBOT) will be initiated 4-6 weeks after enrolment. | Procedure or surgery | Delayed group |
Primary outcome
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.
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
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.
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).
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 23633371O'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.
- Background: PubMed 30124090David 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.
- Background: PubMed 8496220Sarangi 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.
- Background: PubMed 7084977Olander 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.
- Background: PubMed 31104164Knudsen 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.
- Background: PubMed 30777902Stanton-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.
- Background: PubMed 26224572Bruehl S. Complex regional pain syndrome. BMJ. 2015 Jul 29;351:h2730. doi: 10.1136/bmj.h2730.
- Background: PubMed 30399600El-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.
- Background: PubMed 18602869Tsang 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.
- Background: PubMed 10520633Elliott 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Hájek, MD, Ph.D., principal investigator
Municipal Hospital Ostrava Fifejdy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early hyperbaric oxygen therapy (HBOT) and Delayed hyperbaric oxygen therapy (HBOT) in people with Chronic Pain and Complex Regional Pain Syndrome, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Hájek, MD, Ph.D. (+42059619 ext. 2483, michal.hajek@mnof.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07446712, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.