FibromyalgiaNCT02467218
HBOT in Fibromyalgia
A study testing Hyperbaric Oxygen Treatment in people with Fibromyalgia and Chronic Pain, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians. Although the etiology and pathophysiology are poorly understood, there is a well-recognized association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia, abnormal muscle metabolism and oxidative stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- Hyperbaric Oxygen Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Function Improvement Questionnaire (Revised) score ≥ 60 during the baseline assessment.
Who cannot join
- Women with positive pregnancy test or plans to become pregnant during the study period
- Claustrophobia
- Seizure disorder
- Active asthma
- Severe chronic obstructive pulmonary disease
- Previous thoracic surgery
Show all 13Show fewer
- History of pneumothorax
- History of severe congestive heart failure with left ventricular ejection fraction < 30%
- Unstable angina
- Chronic sinusitis
- Chronic or acute otitis media or major ear drum trauma
- Current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
- Participation in another investigative drug or device trial currently or within the last 30 days
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University Health Network
Toronto, Ontario, M5G 2C4
Mount Sinai Hospital
Toronto, Ontario
About this study
Official title: Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians. Although the etiology and pathophysiology are poorly understood, there is a well-recognized association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia, abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM. Pharmacological and non-pharmacological strategies are directed to control symptoms such as pain, fatigue, non-restorative sleep and depression.
Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is based on a dramatic increase in the amount of dissolved oxygen carried by the blood which enables oxygenation of ischemic areas with compromised circulation. It also activates oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory response, induces brain neuroplasticity and possesses analgesic effect.
While some interventions offer benefit for some patients, additional treatment alternatives are needed for patients with FM in whom currently available options are either ineffective or poorly tolerated. Given its physiological effect, HBOT could be considered as a potential therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system and controlling FM symptoms. The results from this study could therefore provide new information supporting the basic science underling the pathophysiology of this disease and stimulate novel therapies for patients suffering with FM.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- Hyperbaric Oxygen Treatment
- Keywords
- Hyperbaric Oxygen Treatment, Fibromyalgia, Global Function, Sleep, Chronic Pain, Depression, Anxiety
- Medical subject headings
- Fibromyalgia, Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TreatmentOther
Baseline and follow up fMRI and Oxygen treatment, 90 minutes, once daily, five times a week for 8 consecutive weeks in the hyperbaric chamber (40 treatments with 100% oxygen at 2.0 ATA)
| Study group | Role | What they receive |
|---|---|---|
| Immediate Hyperbaric Oxygen Treatment | Experimental | If a participant is randomized to the group receiving the intervention, the participant will be receiving a baseline assessment functional magnetic resonance imaging (fMRI) and subsequently receiving hyperbaric oxygen treatment for 90 minutes, once daily, five times a week for 8 consecutive weeks (40 treatments with 100% oxygen at 2.0 ATA). A follow-up fMRI will be performed after the last day of treatment. Receives: Other: Hyperbaric Oxygen Treatment |
| Delayed Hyperbaric Oxygen Treatment | Experimental | If the participant is assigned to the cross group, the participant will also receive a baseline assessment functional magnetic resonance imaging (fMRI). However, it will be followed-up in a controlled manner for 3 months. After 3 months, the participant will be receiving hyperbaric oxygen treatment identical to Group A and a follow-up fMRI will be performed after the last treatment. Receives: Other: Hyperbaric Oxygen Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants finishing the study protocol
Feasibility as a number of participants finishing the study protocol
Measured: 3 months post treatment
Number of participants experiencing intervention related adverse events
Safety as a proportion of patients experiencing intervention-related adverse events during the study period
Measured: Start of Treatment to post 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Katznelson, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467218
- Sponsor's protocol ID
- 14-7888-A
- Status last verified
- Oct 2018
- First submitted
- 20 Apr 2015
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Curtis K, Katz J, Djaiani C, O'Leary G, Uehling J, Carroll J, Santa Mina D, Clarke H, Gofeld M, Katznelson R. Evaluation of a Hyperbaric Oxygen Therapy Intervention in Individuals with Fibromyalgia. Pain Med. 2021 Jun 4;22(6):1324-1332. doi: 10.1093/pm/pnaa416.
PubMed 33594439
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function
- ClinicalTrials.gov ID
- NCT02467218
- Acronym / sponsor ID
- 14-7888-A
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Hyperbaric Oxygen Treatment, Fibromyalgia, Global Function, Sleep, Chronic Pain, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Jun 2015 (estimated)
- 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.
Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians. Although the etiology and pathophysiology are poorly understood, there is a well-recognized association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia, abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM. Pharmacological and non-pharmacological strategies are directed to control symptoms such as pain, fatigue, non-restorative sleep and depression.
Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is based on a dramatic increase in the amount of dissolved oxygen carried by the blood which enables oxygenation of ischemic areas with compromised circulation. It also activates oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory response, induces brain neuroplasticity and possesses analgesic effect.
While some interventions offer benefit for some patients, additional treatment alternatives are needed for patients with FM in whom currently available options are either ineffective or poorly tolerated. Given its physiological effect, HBOT could be considered as a potential therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system and controlling FM symptoms. The results from this study could therefore provide new information supporting the basic science underling the pathophysiology of this disease and stimulate novel therapies for patients suffering with FM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Hyperbaric Oxygen Treatment | Experimental | Other: Hyperbaric Oxygen TreatmentIf a participant is randomized to the group receiving the intervention, the participant will be receiving a baseline assessment functional magnetic resonance imaging (fMRI) and subsequently receiving hyperbaric oxygen treatment for 90 minutes, once daily, five times a week for 8 consecutive weeks (40 treatments with 100% oxygen at 2.0 ATA). A follow-up fMRI will be performed after the last day of treatment. |
| Delayed Hyperbaric Oxygen Treatment | Experimental | Other: Hyperbaric Oxygen TreatmentIf the participant is assigned to the cross group, the participant will also receive a baseline assessment functional magnetic resonance imaging (fMRI). However, it will be followed-up in a controlled manner for 3 months. After 3 months, the participant will be receiving hyperbaric oxygen treatment identical to Group A and a follow-up fMRI will be performed after the last treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Function Improvement Questionnaire (Revised) score ≥ 60 during the baseline assessment.
Key exclusion criteria (13 listed)
- Women with positive pregnancy test or plans to become pregnant during the study period
- Claustrophobia
- Seizure disorder
- Active asthma
- Severe chronic obstructive pulmonary disease
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 |
|---|---|---|
| Hyperbaric Oxygen TreatmentBaseline and follow up fMRI and Oxygen treatment, 90 minutes, once daily, five times a week for 8 consecutive weeks in the hyperbaric chamber (40 treatments with 100% oxygen at 2.0 ATA) | Other | Delayed Hyperbaric Oxygen Treatment, Immediate Hyperbaric Oxygen Treatment |
Primary outcome
Number of participants finishing the study protocol
Time frame: 3 months post treatment
Feasibility as a number of participants finishing the study protocol
Number of participants experiencing intervention related adverse events
Time frame: Start of Treatment to post 3 months
Safety as a proportion of patients experiencing intervention-related adverse events during the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Derived from this study: PubMed 33594439Curtis K, Katz J, Djaiani C, O'Leary G, Uehling J, Carroll J, Santa Mina D, Clarke H, Gofeld M, Katznelson R. Evaluation of a Hyperbaric Oxygen Therapy Intervention in Individuals with Fibromyalgia. Pain Med. 2021 Jun 4;22(6):1324-1332. doi: 10.1093/pm/pnaa416.
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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. This study is not recruiting at the moment.
Rita Katznelson principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Treatment in people with Fibromyalgia and Chronic Pain, run by University Health Network, Toronto at 2 sites in Canada.
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 13 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: finished, as of the sponsor's last update on 17 May 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants finishing the study protocol (time frame: 3 months post treatment). 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 NCT02467218, which also lists 1 linked publication.
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 17 May 2019.