CLINICAL TRIAL TO VALUE THE EFECTIVENESS OF HYPERBARIC OXYGENOTHERAPY IN WOMEN WITH FIBROMYALGIA
- Conditions
- FIBROMYALGIATherapeutic area: Not possible to specify
- Registration Number
- EUCTR2016-004345-85-ES
- Lead Sponsor
- HOSPITAL DE PALAMOS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Women; Age: 18 - 65; Fibromyalgia diagnostic criteria using the ACR criteria 2010; Fibromyalgia Diagnosed over 2 years ago; Severity: Valued by FIQR. FIQR > 39
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Participation in another clinical trial; Pregnancy; she have previously received treatment in hyperbaric chamber or perform diving; Require treatment with OHB during trial; Contraindications for treatment with OHB; neoplasms; Autoimmune rheumatic diseases, Severe mental disorder Inability to sign informed consent; Presence of cognitive impairment (MMSE <27); Smoking
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method