FibromyalgiaNCT04316702
Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
A study testing Hyperbaric oxygen therapy (HBOT) treatment and Cymbalta / Lyrica - Drug treatment in people with Fibromyalgia and Emotional Trauma, 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 to 50 years, women only
- Conditions the study is for
- Fibromyalgia, Emotional Trauma
- What is being tested?
- Hyperbaric oxygen therapy (HBOT) treatment and Cymbalta / Lyrica - Drug treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 30 Nov 2023
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS).
- Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire.
- Ability to provide informed consent
- Age>18
Who cannot join
- Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
- History of traumatic brain injury (TBI)
- Other FM etiologies
- Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)
- Contraindications to both Lyrica and Cymbalta
- Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)
Show all 17Show fewer
- Previous suicidal attempt/s
- Does not take part in psychotherapy on a weekly basis (minimum)
- Previous HBOT for any other reason prior to their inclusion
- Chest pathology (including active asthma)
- Inner ear disease
- Claustrophobia
- Inability to perform awake brain MRI test
- Chronic renal failure (eGFR< 60 ml/min)
- Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery
- Active Smoking
- Pregnancy or not committing to not getting pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms 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 this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma 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 60 fibromyalgia patients in whom emotional trauma, such as childhood abuse, 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 the target medications (Lyrica or Cymbalta).
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 .
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 twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.
- Conditions
- Fibromyalgia, Emotional Trauma
- Being tested
- Hyperbaric oxygen therapy (HBOT) treatment, Cymbalta / Lyrica - Drug treatment
- Medical subject headings
- Fibromyalgia
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 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
Cymbalta / Lyrica - Drug treatmentDrug
one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning).
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen | 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 Receives: Device: Hyperbaric oxygen therapy (HBOT) treatment |
| Pharmacotherapy | Active comparator | Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician. Receives: Drug: Cymbalta / Lyrica - Drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of treatment period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome
Measured: at 3 months
Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of follow up period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome
Measured: at 6 months
Secondary outcomes (24)
Widespread pain index questionnaire
Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (scale 0-19, higher score means worse outcome)
Measured: at baseline, 3 months, 6 months
Symptoms severity scale questionnaire
Fibromyalgia syndrome symptoms questionnaire named:Symptom Severity Scale (SSS) (scale 0-12, higher score means worse outcome)
Measured: at baseline, 3 months, 6 months
Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire
a 17-item semi-structured interview that assesses the presence and severity of Diagnostic and Statistical Manual (DSM-IV) PTSD symptoms related to a single identified traumatic event in individuals with a known trauma history. scale 0-51, higher score means worse outcome
Measured: at baseline, 3 months, 6 months
Medical somatic dissociation questionnaire (MSDQ)
assess somatic dissociation in the healthcare system setting, Scale 5-130, higher score means worse outcome
Measured: at baseline, 3 months, 6 months
Recovery promoting relationships scale (RPRS)
assesses patient-therapist relationships from the patient's perspective.
Measured: at baseline, 3 months, 6 months
the brief symptom inventory (BSI-18)
evaluate psychological distress, three sub-scales: depression, anxiety, and somatization. scale of 0-24, higher score means worse outcome.
Measured: at baseline, 3 months, 6 months
Beck depression inventory (BDI)
a 21-question multiple choice self-report inventory, designed to measure severity of depression. scale of 0-63, higher score means worse outcome
Measured: at baseline, 3 months, 6 months
Short form health survey (sf-36)
Quality of life questionnaire, scale of 0-100, higher score means better outcome
Measured: at baseline, 3 months, 6 months
patient's global impression of change PGIC questionnaire
patient's global impression of change questionnaire, scale of 1-7, higher score means better outcome
Measured: at 3 months, at 6 months
draw a person (DAP) assignment
self drawing tool, allows the expression of hidden or repressed thoughts and feelings in a relatively rapid and simple way by passing the censorship defensive mechanism
Measured: at baseline, 3 months, 6 months
Heat pain threshold
Heat pain threshold is determined as the minimum temperature causing pain. 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). This procedure will be conducted three times for every subject and the mean of the trials will be calculated.
Measured: at baseline, 3 months
conditioned pain modulation using Heat test-stimulus (HTS)
Following heat pain thresholds assessments, the thermode will be applied on the forearm for 120 seconds at constant temperature. The temperature will be individually adapted to induce a mean pain intensity of 50/100, Participant's pain intensity will be evaluated by numeric pain rating scale (NPRS) ranging from 0 (no pain) to 100 (most intense pain tolerable). The 120-second HTS will be done before and during cold water immersion of the contralateral hand in 10 Celsius degrees, using the same thermode temperature to measure conditioned pain modulation (CPM). CPM efficiency will be evaluated by computing the difference in mean pain intensity induced by the pressure stimulus and the Heat test-stimulus (HTS) before and during the Cold water immersion of the opposite hand. Thus, effective pain inhibitory mechanisms are represented by higher (positive) values
Measured: at baseline, 3 months
Cerebral blood volume
Cerebral blood volume (in milliliter) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
Measured: at baseline, 3 months
Cerebral blood Flow
Cerebral blood volume (in milliliter/min) will be measured using perfusion MRI protocol Dynamic susceptibility contrast (DSC).
Measured: at baseline, 3 months
Fractional anisotropy
Brain microstructure imaging will evaluate fractional anisotropy (FA , scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI)
Measured: at baseline, 3 months
Mean diffusivity
Brain microstructure imaging will evaluate mean diffusivity (MD, scale 0-1 in each region of interest. The MRI protocol will include diffusion tensor imaging (DTI).
Measured: at baseline, 3 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: at baseline, 3 months
Metabolic Brain function imaging
Brain Single photon emission computed tomography (SPECT) will be conducted.
Measured: at baseline, 3 months
Brain functionality
FMRI tasks will evaluate brain function during cognitive (working memory task) and emotional tasks (emotion recognition task)
Measured: at baseline, 3 months
NeuroTrax
computerized cognitive evaluation battery
Measured: at baseline, 3 months
CANTAB Cambridge Neuropsychological Test Automated Battery
computerized cognitive evaluation battery
Measured: at baseline, 3 months
Physical activity
The daily physical activity will be objectively tracked by Garmin watch technology. The watch will be also wired during night for measurements of the time asleep, restless and awake, trackers help you understand each night to make the most of each day
Measured: at baseline, 3 months
Inflammatory cytokines
Blood Tests will include: IL-1, IL-6, Tumor necrosis factor-alpha, C-reactive protein (CRP).
Measured: at baseline, 3 months
Endocrine system
Free cortisol, Adrenocorticotropic hormone (ACTH) in blood tests and a hair sample for cortisol levels
Measured: at baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Mar 2020
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- The Emili Sagol Creative Arts Therapies Research Center
- 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
- NCT04316702
- Sponsor's protocol ID
- 0008-20
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2020
- Last updated
- 21 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial
- ClinicalTrials.gov ID
- NCT04316702
- Acronym / sponsor ID
- 0008-20
- Conditions
- Fibromyalgia, Emotional Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- The Emili Sagol Creative Arts Therapies Research Center
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 20 Mar 2020 (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 this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma 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 60 fibromyalgia patients in whom emotional trauma, such as childhood abuse, 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 the target medications (Lyrica or Cymbalta).
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 .
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 twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.
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 | 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 |
| Pharmacotherapy | Active comparator | Drug: Cymbalta / Lyrica - Drug treatmentTwo medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS).
- Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire.
- Ability to provide informed consent
- Age>18
Key exclusion criteria (17 listed)
- Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
- History of traumatic brain injury (TBI)
- Other FM etiologies
- Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)
- Contraindications to both Lyrica and Cymbalta
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 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 | Device | Hyperbaric Oxygen |
| Cymbalta / Lyrica - Drug treatmentone of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). | Drug | Pharmacotherapy |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Time frame: at 3 months
Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of treatment period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome
Fibromyalgia Impact Questionnaire (FIQ) questionnaire
Time frame: at 6 months
Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of follow up period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome
24 secondary outcomes
Widespread pain index questionnaire
Time frame: at baseline, 3 months, 6 months
Symptoms severity scale questionnaire
Time frame: at baseline, 3 months, 6 months
Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire
Time frame: at baseline, 3 months, 6 months
Medical somatic dissociation questionnaire (MSDQ)
Time frame: at baseline, 3 months, 6 months
Recovery promoting relationships scale (RPRS)
Time frame: at baseline, 3 months, 6 months
the brief symptom inventory (BSI-18)
Time frame: at baseline, 3 months, 6 months
Beck depression inventory (BDI)
Time frame: at baseline, 3 months, 6 months
Short form health survey (sf-36)
Time frame: at baseline, 3 months, 6 months
patient's global impression of change PGIC questionnaire
Time frame: at 3 months, at 6 months
draw a person (DAP) assignment
Time frame: at baseline, 3 months, 6 months
Heat pain threshold
Time frame: at baseline, 3 months
conditioned pain modulation using Heat test-stimulus (HTS)
Time frame: at baseline, 3 months
Cerebral blood volume
Time frame: at baseline, 3 months
Cerebral blood Flow
Time frame: at baseline, 3 months
Fractional anisotropy
Time frame: at baseline, 3 months
Mean diffusivity
Time frame: at baseline, 3 months
Brain function imaging
Time frame: at baseline, 3 months
Metabolic Brain function imaging
Time frame: at baseline, 3 months
Brain functionality
Time frame: at baseline, 3 months
NeuroTrax
Time frame: at baseline, 3 months
CANTAB Cambridge Neuropsychological Test Automated Battery
Time frame: at baseline, 3 months
Physical activity
Time frame: at baseline, 3 months
Inflammatory cytokines
Time frame: at baseline, 3 months
Endocrine system
Time frame: at baseline, 3 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 21 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 and Cymbalta / Lyrica - Drug treatment in people with Fibromyalgia and Emotional Trauma, 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 4 inclusion and 17 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 21 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?
Fibromyalgia Impact Questionnaire (FIQ) questionnaire (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 21 Apr 2026.