Clinical trial NCT04316702: Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Emotional Trauma
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Emili Sagol Creative Arts Therapies Research Center
First posted: 2020-03-20
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized controlled trial using conventional pharmacotherapy treatment compared to hyperbaric oxygen therapy
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ) questionnaire
timeFrame: at 3 months
measure: Fibromyalgia Impact Questionnaire (FIQ) questionnaire
timeFrame: at 6 months
Secondary outcomes:
measure: Widespread pain index questionnaire
timeFrame: at baseline, 3 months, 6 months
measure: Symptoms severity scale questionnaire
timeFrame: at baseline, 3 months, 6 months
measure: Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire
timeFrame: at baseline, 3 months, 6 months
measure: Medical somatic dissociation questionnaire (MSDQ)
timeFrame: at baseline, 3 months, 6 months
measure: Recovery promoting relationships scale (RPRS)
timeFrame: at baseline, 3 months, 6 months
measure: the brief symptom inventory (BSI-18)
timeFrame: at baseline, 3 months, 6 months
measure: Beck depression inventory (BDI)
timeFrame: at baseline, 3 months, 6 months
measure: Short form health survey (sf-36)
timeFrame: at baseline, 3 months, 6 months
measure: patient's global impression of change PGIC questionnaire
timeFrame: at 3 months, at 6 months
measure: draw a person (DAP) assignment
timeFrame: at baseline, 3 months, 6 months
measure: Heat pain threshold
timeFrame: at baseline, 3 months
measure: conditioned pain modulation using Heat test-stimulus (HTS)
timeFrame: at baseline, 3 months
measure: Cerebral blood volume
timeFrame: at baseline, 3 months
measure: Cerebral blood Flow
timeFrame: at baseline, 3 months
measure: Fractional anisotropy
timeFrame: at baseline, 3 months
measure: Mean diffusivity
timeFrame: at baseline, 3 months
measure: Brain function imaging
timeFrame: at baseline, 3 months
measure: Metabolic Brain function imaging
timeFrame: at baseline, 3 months
measure: Brain functionality
timeFrame: at baseline, 3 months
measure: NeuroTrax
timeFrame: at baseline, 3 months
measure: CANTAB Cambridge Neuropsychological Test Automated Battery
timeFrame: at baseline, 3 months
measure: Physical activity
timeFrame: at baseline, 3 months
measure: Inflammatory cytokines
timeFrame: at baseline, 3 months
measure: Endocrine system
timeFrame: at baseline, 3 months
Other outcomes:
Locations:
city: Rishon lezion
country: Israel
facility: hyperbaric center Asaf harofe medical center
Study officials:
affiliation: Asaf-Harofhe MC
name: Shai a Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References: