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HOTFy: randomised clinical trial to Hyperbaric Oxygen Therapy in Fibromyalgia

HOTFy: randomised clinical trial to Hyperbaric Oxygen Therapy in Fibromyalgia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-6prps8g
Enrollment
Unknown
Registered
2022-06-17
Start date
2022-12-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Fibromyalgia

Interventions

Intervention: 40 sessions of hyperbaric oxygen therapy at 2.3 ATA for 90 minutes 5 times a week vs. conventional treatment for fibromyalgia with guidance on the disease, physical exercises 3 times a w

Sponsors

Universidade Federal de Juiz de Fora
Lead Sponsor
Universidade Federal de Juiz de Fora
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ages between 18-70 years; diagnosis of fibromyalgia at least 2 years prior to enrollment based on one of two criteria: symptoms of generalized pain occurring above and below the waist and affecting the right and left sides of the body for at least 3 months and not having another somatic disorder that warrants the symptoms and/or presence of at least 11 of the 18 tender points (“Tender Points”).

Exclusion criteria

Exclusion criteria: contraindications for hyperbaric oxygen therapy (pregnancy, use of bleomycin, cisplatin, disulfiram and doxorubicin, middle ear surgery, untreated pneumothorax or pneumomediastinum, claustrophobia); associated autoimmune rheumatologic disease and inability to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Improvement (lower score) of the somatic impairment clinical assessment questionnaires (Visual Analogue Scale [VAS] and Brazilian Portuguese version of the Fibromyalgia Global, Functional and Symptomatic Assessment Questionnaire [FIQR-Br]) and neuropsychiatric (Psychological Symptoms Assessment Scale [EAS-40] ) of patients with fibromyalgia and to identify the best moment of application through the analysis of the results of the questionnaires applied at different times and in different groups

Secondary

MeasureTime frame
Assess the impact of new technology on the quality of life in the fibromyalgia patients through the analysis of the SF-12 score

Countries

Brazil

Contacts

Public ContactJose da Mota Neto

Universidade Federal de Juiz de Fora

jose.jmota@ebserh.gov.br+55(32)999120909

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 10, 2026