NCT03376269

Brief Summary

The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

April 6, 2015

Last Update Submit

April 16, 2026

Conditions

FibromyalgiaChronic Pain Syndrome

Keywords

more than 1 year

Outcome Measures

Primary Outcomes (3)

  • Pain sensitivity

    Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)

    Change After 3 months

  • Brain microstructure

    MRI dynamic tensor imaging sequence will be performed (DTI). Fractional anisotropy (FA) values will be assessed at base line and at 3 months. The changes at 3 months from baseline will be compared

    Change after 3 months

  • Brain Metabolism

    Brain metabolism will be assessed using SPECT at baseline, 3 monthsThe counts for each different Broadmann area values will be calculated. The changes at 3 months from baseline will be compared.

    Change after 3 months

Secondary Outcomes (7)

  • Fibromyalgia Impact on quality of life

    Change after 3 months

  • Short form health survey (sf-36)

    Change after 3 months

  • Stress

    Change after 3 months t

  • Psychological symptoms

    Change after 3 months

  • Sensory symptoms

    Change after 3 months

  • +2 more secondary outcomes

Study Arms (2)

Combined HBOT/psychotherapy

ACTIVE COMPARATOR

combined concurrent intervention of HBOT and creative art psychotherapy.

Biological: HBOTBehavioral: Psychotherapy

psychotherapy

OTHER

single intervention with creative art psychotherapy

Behavioral: Psychotherapy

Interventions

HBOTBIOLOGICAL

•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments

Combined HBOT/psychotherapy
PsychotherapyBEHAVIORAL

creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions

Combined HBOT/psychotherapypsychotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females
  • Age over 18
  • Known fibromyalgia (chronic pain syndrome) for more than 1 year

You may not qualify if:

  • Patients with chest x-ray pathology incompatible with hyperbaric environment
  • Patients with middle ear problems
  • Patients, who cannot "pump", equals middle ear pressure, effectively
  • Patients who suffer from claustrophobia
  • Inability or Refusing to sign the Informed Consent Form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (1)

  • Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018.

    PMID: 30618929DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Shai a Efrati, MD

    Asaf-Harofhe MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Sagol Center for Hyperbaric medicine and Research

Study Record Dates

First Submitted

April 6, 2015

First Posted

December 18, 2017

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Study Completion

November 1, 2017

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

IL(1)