Effectiveness of Hyperbaric oxygen therapy versus conventional treatment in Fibromyagia Pain.

Efficacy of Hyperbaric Oxygen therapy Versus Conventional Treatment in Fibromyalgia Pain: A Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099337

Enrollment

124

Registered

2025-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: M797- Fibromyalgia

Interventions

Intervention1: Hyperbaric Oxygen Therapy: The protocol involved twenty 90-minute sessions one session on three days per week during which they breathed 100 percent oxygen at 2.5 ata with air breaks. E

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years with any gender. Diagnosed patients according the ACR criteria for Fibromyalgia. Symptoms present for at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Inflammatory causes of pain 2. Alcohol/drug abuse or dependence 3. Significant difficulty in maintaining attention or understanding clinometric evaluation instructions 4. Any clinical condition that may interfere with the assessment. 5. Pregnant women or potentially childbearing women not using an adequate method of birth control. 6. Any of the following medical conditions that preclude safe HBOT treatment: a) severe cognitive impairment; b) current mood episodes, claustrophobia or seizure disorder; c) active or severe pulmonary disease, previous thoracic surgery or pneumothorax; d) a history of severe heart disease; e) chronic or acute sinusitis/otitis media or major eardrum trauma; and f) a history of bleomycin-including chemotherapy or current chemotherapy.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of hyperbaric oxygen therapy (HBOT) and conventional treatment in reducing pain using tender points assessment in fibromyalgia patients. Timepoint: All the eligible patients will be evaluated at baseline for pain, fatigue and their QOL. After that re-evaluation will be using the same instruments after 10 and 20 HBOT sessions. In the conventional group B assessment will be done at 4 week and 8 week after starting the exercises programme.	—

Measure

Time frame

To compare the efficacy of hyperbaric oxygen therapy (HBOT) and conventional treatment in reducing pain using tender points assessment in fibromyalgia patients. Timepoint: All the eligible patients will be evaluated at baseline for pain, fatigue and their QOL. After that re-evaluation will be using the same instruments after 10 and 20 HBOT sessions. In the conventional group B assessment will be done at 4 week and 8 week after starting the exercises programme.

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Secondary

Measure	Time frame
To compare the efficacy of HBOT and conventional treatment in terms of : Fatigue Quality of Life Timepoint: All the eligible patients will be evaluated at baseline for pain, fatigue and their QOL. After that re-evaluation will be using the same instruments after 10 and 20 HBOT sessions. In the conventional group B assessment will be done at 3 week and 6 week after starting the exercises programme.	—

Measure

Time frame

To compare the efficacy of HBOT and conventional treatment in terms of : Fatigue Quality of Life Timepoint: All the eligible patients will be evaluated at baseline for pain, fatigue and their QOL. After that re-evaluation will be using the same instruments after 10 and 20 HBOT sessions. In the conventional group B assessment will be done at 3 week and 6 week after starting the exercises programme.

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Countries

India

Contacts

Public ContactDr Vinay Kanaujia

Uttar Pradesh Univesity of Medical sciences, Saifai, Etawah

vinay.kanaujia87@gmail.com8800121450

Outcome results

None listed

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