Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma

Assaf-Harofeh Medical Center48 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Interventions

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: at 6 months

Secondary Outcomes

Widespread pain index questionnaire

Fibromyalgia syndrome symptoms questionnaire named:Wide Spread Pain Index (scale 0-19, higher score means worse outcome)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: at baseline, 3 months, 6 months

Recovery promoting relationships scale (RPRS)

assesses patient-therapist relationships from the patient's perspective.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.