FibromyalgiaFMSRCTNCT03325959
Hyperbaric Oxygen Compared to Pharmaceutical Therapies for Fibromyalgia Syndrome
A study testing Hyperbaric oxygen therapy (HBOT) treatment, Cymbalta / Lyrica treatment and Crossover Hyperbaric oxygen therapy in people with Fibromyalgia and Hyperbaric Oxygen, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Hyperbaric Oxygen
- What is being tested?
- Hyperbaric oxygen therapy (HBOT) treatment, Cymbalta / Lyrica treatment and Crossover Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 1 Jun 2022
- 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
- FMS diagnosis, based on the updated 2016 diagnostic criteria
- previous physical trauma (such as traumatic brain injury)
Who cannot join
- the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
- active malignancy,
- chronic ongoing infection
- major psychiatric disorders (excluding anxiety)
- Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded
- previous HBOT for any other reason prior to their inclusion;
Show all 15Show fewer
- Chest pathology incompatible with pressure changes (including active asthma);
- Inner ear disease
- Claustrophobia;
- Inability to perform awake brain MRI test;
- Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.);
- Brain tumors;
- Skull base fractures;
- s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, (Patients suffering from Encephalomalacia per MRI imaging will not be excluded).
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome - Prospective, Randomized Crossover Clinical Trial
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.
In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment.
In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
Read the detailed description
The study will include 70 fibromyalgia patients in whom physical trauma, such mild traumatic brain injury (mTBI), could be considered as the trigger for FMS. Each participant will be examined at the time of recruitment and a diagnosis of FMS will be verified, based on the updated 2016 diagnostic criteria In the current study the investigators will recruit patients not currently being treated with medications specific for FMS, including anti-depression drugs, gabapentanoids and tricyclics, opiods and medical cannabis. Patients who are on such treatment will be required to discontinue treatment 2 weeks before recruitment.
Patients will undergo randomization upon recruitment to one of the two study groups. One group will proceed to a course of HBOT treatment while the second group will commence with standard treatment for FMS, as outlined in the Israeli guidelines for the diagnosis and treatment of FMS [41]. These patients will be given detailed education regarding the nature of FMS as well as recommendations regarding non - pharmacological interventions recommended for FMS, including graded physical exercise, hydrotherapy, movement-meditative treatments (e.g. Tai Chi) and cognitive behavioral treatment (CBT).
HBOT protocol: a total of 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. 60 sessions will include exposure of 90 minutes to 100% at 2 Absolute atmospheres (ATA), with 5 minutes air breaks every 20 minutes.
Pharmaceutical protocol: patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment.
Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.
- Conditions
- Fibromyalgia, Hyperbaric Oxygen
- Being tested
- Hyperbaric oxygen therapy (HBOT) treatment, Cymbalta / Lyrica treatment, Crossover Hyperbaric oxygen therapy
- Keywords
- hyperbaric oxygen, HBOT, fibromyalgia, pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapy (HBOT) treatmentDevice
60 HBOT sessions at 2 ATA 100% oxygen
Cymbalta / Lyrica treatmentDrug
Also called Cymbalta / Lyrica
one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica.
Crossover Hyperbaric oxygen therapyDevice
60 HBOT sessions at 2 ATA 100% oxygen after crossover
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Active comparator | 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group. Receives: Device: Hyperbaric oxygen therapy (HBOT) treatment |
| Pharmacotherapy | Active comparator | patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment.
Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group. Receives: Drug: Cymbalta / Lyrica treatment; Device: Crossover Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue Scale (VAS)
The primary end point of the study will be the measurement of daily pain on a (0-10) Visual analogue Scale
Measured: at 3 months
Visual analogue Scale (VAS)
The primary end point of the study will be the measurement of daily pain on a (0-10 scale) Visual analogue Scale
Measured: at 6 months
Secondary outcomes (30)
Global Pain Scale (GPS)
Fibromyalgia syndrome symptoms questionnaire named Global Pain Scale (GPS) questionnaire (0-100 scale)
Measured: baseline, at 3 months, at 6 months
Patient global impression of change
Fibromyalgia syndrome symptoms questionnaire named: Patient global impression of change (yes/no)
Measured: baseline, at 3 months, at 6 months
Fibromyalgia Impact Questionnaire
Fibromyalgia syndrome symptoms questionnaire named: Fibromyalgia Impact Questionnaire - FIQ (Hebrew version) (0-100 scale)
Measured: baseline, at 3 months, at 6 months
Wide Spread Pain Index
Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (WPI) Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (scale 0-19)
Measured: baseline, at 3 months, at 6 months
Symptom Severity Scale
Fibromyalgia syndrome symptoms questionnaire named:Symptom Severity Scale (SSS) (scale 0-12)
Measured: baseline, at 3 months, at 6 months
SF-36 questionnaire
Quality of life questionnaire named short-form 36 (SF-36) (scale 0-100)
Measured: baseline, at 3 months, at 6 months
Medical Outcome Sleep Scale
Sleep qualtiy questionnaire named: Medical Outcome Sleep Scale (MOS) questionnaire (0-100 scale)
Measured: baseline, at 3 months, at 6 months
Beck Depression Inventory
Depression questionnaire named Beck Depression Inventory (BDI-II) (scale 0-63)
Measured: baseline, at 3 months, at 6 months
EQ-5D
Quality of life questionnaire named EQ-5D (scale 0-25)
Measured: baseline, at 3 months, at 6 months
Cognitive function
The Mindstreams battery includes several cognitive tests devised to check various aspects of brain capabilities. In the current study we will evaluate the cognitive indices based on the scores of the 6 cognitive tests listed below, which are expected to be relevant for mild TBI. For detailed description of all cognitive tests in Mindstreams battery
Measured: baseline, at 3 months, at 6 months
Cognitive function - CANTAB
Patients' cognitive functions will be assessed by CANTAB computerized cognitive tests (Cambrdige cognition , England) [52]. The CANTAB is a semiautomated test battery which can be administered on a laptop PC and more recently has been modified for administration on a handheld tablet. The current release of CANTAB Eclipse comprises 25 tests designed to assess components of cognitive function which fall into 7 broad groups of tests: visual memory, executive function, working memory and planning, attention, semantic/verbal memory, decision making and response control, social cognition, and screening/familiarization.
Measured: baseline, at 3 months, at 6 months
Cerebral blood volume
Cerebral blood volume (in mililiter) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
- DSC: 50 T2*-weighted gradient-echo echo planar imaging (EPI) volumes will be acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA.
Measured: baseline, at 3 months, at 6 months
Cerebral blood flow
Cerebral blood volume (in mililiter/min) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
- DSC: 50 T2*-weighted gradient-echo echo planar imaging (EPI) volumes will be acquired, 2 repetitions before a bolus injection of Gadolinium-DTPA (Gd-DTPA), 48 repetitions after injection of Gd-DTPA.
Measured: baseline, at 3 months, at 6 months
Fractional anistropy
Brain microstructure imaging will evalute fractional anistropy (FA , scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI).
MRI sequence parameters:
- DTI: 30 diffusion weighted images will be scanned with different gradient directions (b=1000) and one volume without diffusion weighting
Measured: baseline, at 3 months, at 6 months
Mean diffusivity
Brain microstructure imaging will evalute mean diffusivity (MD, scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI).
MRI sequence parameters:
- DTI: 30 diffusion weighted images will be scanned with different gradient directions (b=1000) and one volume without diffusion weighting
Measured: baseline, at 3 months, at 6 months
Brain function imaging
Resting state fMRI(rsfMRI or R-fMRI)- a method of functional brain imaging that can be used to evaluate regional interactions that occur when a subject is not performing an explicit task. This resting brain activity is observed through changes in blood flow in the brain which creates what is referred to as a blood-oxygen-level dependent (BOLD) signal that can be measured using functional Magnetic Resonance Imaging (fMRI).
Measured: baseline, at 3 months, at 6 months
brain function imaging
Brain photon emission computed tomography (PET-CT) will be conducted using FDG.
Measured: baseline, at 3 months, at 6 months
Brain network analysis
EEG activity will be recorded at resting state , during performing cognitive tasks and following a trans-magnetic stimulation. EEG recording will be performed using a 64 electrodes cap.
Measured: baseline, at 3 months, at 6 months
Heat/Cold Pain threshold evaluation
Thermal pain is induced with thermal electrode (thermode). Thermode temperature will initially be set at 32.0°C and gradually increase at a rate of 0.3°C/sec. Participants will be instructed to report when the sensation produced by the thermode changed from heat sensation to pain (heat pain threshold) and when the pain became unbearable (heat pain tolerance). This procedure will be conducted twice for every subject and the mean of the two trials will be calculated. The thermode will be placed on adjacent areas of the forearm for every trial to avoid primary skin hyperalgesia.
Measured: baseline, at 3 months, at 6 months
Conditioned pain modulation
In the current study CPM efficiency will be evaluated by computing the difference in mean pain intensity induced by the Heat test-stimulus (HTS) before and during immersion of non-dominant hand to 10 degrees cold water (the Cold pressor test) (i.e., pain during pre-immersion HTS - pain during post-immersion HTS). Thus, effective pain inhibitory mechanisms are represented by higher (positive) values.
Measured: baseline, at 3 months, at 6 months
Physical activity
The daily physical activity will be objectively tracked by FitBit watch technology. The FitBit watch will be also wired during night for measurements of the time asleep, restless and awake, Fitbit trackers help you understand each night to make the most of each day
Measured: baseline, at 3 months, at 6 months
Exercise capacity
Participants will undergo exercise testing using a modified Balke treadmill protocol and continuous expired gas analysis. Resting and exercise vital signs will monitored continuously. The exercise duration and exercise-limiting symptoms will be recorded. The peak VO2, VCO2 and respiratory exchange ratio (RER) will be averaged over the last 15 seconds of the exercise test. The ventilatory equivalent (VE/VCO2 slope) will be calculated from start of exercise to the end of exercise.
Measured: baseline, at 3 months, at 6 months
Inflammatory cytokines
Blood Tests will include: IL-1, IL-6, Tumor necrosis factor-alpha, CRP.
Measured: baseline, at 3 months, at 6 months
CD4 number
CD4 number (cells per ml) .Using a 4-color FACS CD4 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis.
PBMCs will be will behed twice in PBS with 3% FCS. 1X10^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies.
Measured: baseline, at 3 months, at 6 months
CD8 number
CD8 number (cells per ml) .Using a 4-color FACS CD8 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis.
PBMCs will be will behed twice in PBS with 3% FCS. 1X10^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies.
Measured: baseline, at 3 months, at 6 months
CD4:CD8 ratio
CD4:CD8 number (ratio) .Using a 4-color FACS CD4:CD8 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis.
PBMCs will be will behed twice in PBS with 3% FCS. 1X10^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies.
Measured: baseline, at 3 months, at 6 months
CD8+CD28null
CD8+CD28null number (cells/ml) .Using a 4-color FACS CD8+CD28null number will be evaluated.
Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis.
PBMCs will be will behed twice in PBS with 3% FCS. 1X10^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies.
Measured: baseline, at 3 months, at 6 months
Naïve B-Cells number
B cell number (cells/ml) .Using a 4-color FACS B cells number will be evaluated.
Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis.
PBMCs will be will behed twice in PBS with 3% FCS. 1X10^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies.
Measured: baseline, at 3 months, at 6 months
CD4CD25 positive number
CD4CD25 cell number (cells/ml) .Using a 4-color FACS CD4CD25 number will be evaluated.
Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis.
PBMCs will be will behed twice in PBS with 3% FCS. 1X10^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies.
Measured: baseline, at 3 months, at 6 months
Microbiome
Microbiome evaluation method: Using our cutting-edge facilities, 16S ribosomal RNA (rRNA) next-generation sequencing of fecal samples will be performed to identify bacteria present in the gut. 16S rRNA gene sequencing is a well-established method for studying phylogeny and taxonomy (the description, identification and evolutionary classification) of samples from complex microbial environments that are difficult to study.
Measured: baseline, at 3 months, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Mar 2017
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- randomized controlled trial using conventional pharmacotherapy treatment compared to hyperbaric oxygen therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325959
- Sponsor's protocol ID
- 0058-17-ASF
- Acronym
- FMSRCT
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome - Prospective, Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT03325959
- Acronym / sponsor ID
- FMSRCT / 0058-17-ASF
- Conditions
- Fibromyalgia, Hyperbaric Oxygen
- Keywords
- hyperbaric oxygen, HBOT, fibromyalgia, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 30 Oct 2017 (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 investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.
In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment.
In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
Detailed description
The study will include 70 fibromyalgia patients in whom physical trauma, such mild traumatic brain injury (mTBI), could be considered as the trigger for FMS. Each participant will be examined at the time of recruitment and a diagnosis of FMS will be verified, based on the updated 2016 diagnostic criteria In the current study the investigators will recruit patients not currently being treated with medications specific for FMS, including anti-depression drugs, gabapentanoids and tricyclics, opiods and medical cannabis. Patients who are on such treatment will be required to discontinue treatment 2 weeks before recruitment.
Patients will undergo randomization upon recruitment to one of the two study groups. One group will proceed to a course of HBOT treatment while the second group will commence with standard treatment for FMS, as outlined in the Israeli guidelines for the diagnosis and treatment of FMS [41]. These patients will be given detailed education regarding the nature of FMS as well as recommendations regarding non - pharmacological interventions recommended for FMS, including graded physical exercise, hydrotherapy, movement-meditative treatments (e.g. Tai Chi) and cognitive behavioral treatment (CBT).
HBOT protocol: a total of 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. 60 sessions will include exposure of 90 minutes to 100% at 2 Absolute atmospheres (ATA), with 5 minutes air breaks every 20 minutes.
Pharmaceutical protocol: patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment.
Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial using conventional pharmacotherapy treatment compared to hyperbaric oxygen therapy
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Active comparator | Device: Hyperbaric oxygen therapy (HBOT) treatment60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group. |
| Pharmacotherapy | Active comparator | Drug: Cymbalta / Lyrica treatment, Device: Crossover Hyperbaric oxygen therapypatients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment. Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- FMS diagnosis, based on the updated 2016 diagnostic criteria
- previous physical trauma (such as traumatic brain injury)
Key exclusion criteria (15 listed)
- the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
- active malignancy,
- chronic ongoing infection
- major psychiatric disorders (excluding anxiety)
- Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded
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 therapy (HBOT) treatment60 HBOT sessions at 2 ATA 100% oxygen | Device | Hyperbaric oxygen therapy |
| Cymbalta / Lyrica treatmentAlso: Cymbalta / Lyricaone of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. | Drug | Pharmacotherapy |
| Crossover Hyperbaric oxygen therapy60 HBOT sessions at 2 ATA 100% oxygen after crossover | Device | Pharmacotherapy |
Primary outcome
Visual analogue Scale (VAS)
Time frame: at 3 months
The primary end point of the study will be the measurement of daily pain on a (0-10) Visual analogue Scale
Visual analogue Scale (VAS)
Time frame: at 6 months
The primary end point of the study will be the measurement of daily pain on a (0-10 scale) Visual analogue Scale
30 secondary outcomes
Global Pain Scale (GPS)
Time frame: baseline, at 3 months, at 6 months
Patient global impression of change
Time frame: baseline, at 3 months, at 6 months
Fibromyalgia Impact Questionnaire
Time frame: baseline, at 3 months, at 6 months
Wide Spread Pain Index
Time frame: baseline, at 3 months, at 6 months
Symptom Severity Scale
Time frame: baseline, at 3 months, at 6 months
SF-36 questionnaire
Time frame: baseline, at 3 months, at 6 months
Medical Outcome Sleep Scale
Time frame: baseline, at 3 months, at 6 months
Beck Depression Inventory
Time frame: baseline, at 3 months, at 6 months
EQ-5D
Time frame: baseline, at 3 months, at 6 months
Cognitive function
Time frame: baseline, at 3 months, at 6 months
Cognitive function - CANTAB
Time frame: baseline, at 3 months, at 6 months
Cerebral blood volume
Time frame: baseline, at 3 months, at 6 months
Cerebral blood flow
Time frame: baseline, at 3 months, at 6 months
Fractional anistropy
Time frame: baseline, at 3 months, at 6 months
Mean diffusivity
Time frame: baseline, at 3 months, at 6 months
Brain function imaging
Time frame: baseline, at 3 months, at 6 months
brain function imaging
Time frame: baseline, at 3 months, at 6 months
Brain network analysis
Time frame: baseline, at 3 months, at 6 months
Heat/Cold Pain threshold evaluation
Time frame: baseline, at 3 months, at 6 months
Conditioned pain modulation
Time frame: baseline, at 3 months, at 6 months
Physical activity
Time frame: baseline, at 3 months, at 6 months
Exercise capacity
Time frame: baseline, at 3 months, at 6 months
Inflammatory cytokines
Time frame: baseline, at 3 months, at 6 months
CD4 number
Time frame: baseline, at 3 months, at 6 months
CD8 number
Time frame: baseline, at 3 months, at 6 months
CD4:CD8 ratio
Time frame: baseline, at 3 months, at 6 months
CD8+CD28null
Time frame: baseline, at 3 months, at 6 months
Naïve B-Cells number
Time frame: baseline, at 3 months, at 6 months
CD4CD25 positive number
Time frame: baseline, at 3 months, at 6 months
Microbiome
Time frame: baseline, at 3 months, at 6 months
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy (HBOT) treatment, Cymbalta / Lyrica treatment and Crossover Hyperbaric oxygen therapy in people with Fibromyalgia and Hyperbaric Oxygen, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 15 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Visual analogue Scale (VAS) (time frame: at 3 months). 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?
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 22 Apr 2026.