CLINICAL TRIAL TO VALUE THE EFECTIVENESS OF HYPERBARIC OXYGENOTHERAPY IN WOMEN WITH FIBROMYALGIA

RANDOMIZED CLINICAL TRIAL WITH TWO PATIENT AND PROFESSIONAL PARALLEL MASKS AND AN OPEN GROUP TO VALUE THE EFECTIVENESS AND EFFICIENCY OF HYPERBARIC OXYGENOTHERAPY WITH FOLLOW-UP TO A YEAR IN WOMEN WITH SEVERE OR MODERATE FIBROMYALGIA - CLINICAL TRIAL TO VALUE THE EFECTIVENESS OF HYPERBARIC OXYGENOTHERAPY IN WOMEN WITH FIBROMYALGIA

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004345-85-ES

Enrollment

Unknown

Registered

2017-01-13

Start date

2017-01-31

Completion date

Unknown

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FIBROMYALGIA

Interventions

Trade Name: Oxígeno Medicinal Líquido Praxair Product Name: HYPERBARIC OXYGEN Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: OXYGEN CAS Number: 007782-44-7 Concentration unit: % p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Revised Fibromyalgia Impact Questionnaire (FIQR) average score will be used as primary endpoint in successive evaluations. In this study we consider that treatment with OHB is effective if an improvement of 25% of the average score of FIQR and partially effective between 14-25% is achieved. Thus we assess the effectiveness of OHB in the treatment of fibromyalgia.;Secondary Objective: To assess the efficiency and cost-effectiveness measures consumption of health resources and measures of indirect costs (lost productivity, individual costs of alternative therapies, etc.) will be used.;Primary end point(s): They will be collected during the study and come from clinical interviews, blood draws and various self-administered patient questionnaires. Each patient will have a total of 6 evaluations first for inclusion in the study and rest for the implementation of the monitoring protocol that will last a total of 61 weeks.;Timepoint(s) of evaluation of this end point: 6 evaluations first for inclusion in the study and rest for the implementation of the monitoring protocol that will last a total of 61 weeks.	—

Measure

Time frame

Main Objective: Revised Fibromyalgia Impact Questionnaire (FIQR) average score will be used as primary endpoint in successive evaluations. In this study we consider that treatment with OHB is effective if an improvement of 25% of the average score of FIQR and partially effective between 14-25% is achieved. Thus we assess the effectiveness of OHB in the treatment of fibromyalgia.;Secondary Objective: To assess the efficiency and cost-effectiveness measures consumption of health resources and measures of indirect costs (lost productivity, individual costs of alternative therapies, etc.) will be used.;Primary end point(s): They will be collected during the study and come from clinical interviews, blood draws and various self-administered patient questionnaires. Each patient will have a total of 6 evaluations first for inclusion in the study and rest for the implementation of the monitoring protocol that will last a total of 61 weeks.;Timepoint(s) of evaluation of this end point: 6 evaluations first for inclusion in the study and rest for the implementation of the monitoring protocol that will last a total of 61 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Spain

Contacts

Public ContactSECRETARIA TECNICA DE RECERCA

HOSPITAL DE PALAMOS

mrovira@ssibe.cat34972609226

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026