The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02984943
• Date of registration: 15/11/2016
• Prospective Registration: Yes
• Primary sponsor: David Grant U.S. Air Force Medical Center
• Public title: The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis
• Scientific title: The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study
• Date of first enrolment: January 19, 2017
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02984943
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michelle T Sit, MD
• Affiliation: David Grant Medical Center. Travis AFB

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age = 18

2. Active duty or Department of Defense (DoD) beneficiary

3. Diagnosed with rheumatoid arthritis meeting ACR/EULAR 2010 classification criteria and
any one of the following:

1. Patient does not want to be on rheumatologic medications

2. Patient has contraindications to standard rheumatologic medications

3. Patient has failed treatment or an incomplete response with standard
rheumatologic medications

4. Women of childbearing age must have a negative pregnancy test and currently be on a
reliable form of birth control

Exclusion Criteria:

1. Severe depression

2. Dementia, mental disability

3. Claustrophobia

4. Uncontrolled seizure disorder

5. Uncontrolled asthma/severe chronic obstructive pulmonary disease (COPD) with partial
pressure of carbon dioxide (pCO2) > 45 mmHg on arterial blood gas

6. Grade 4 congestive heart failure

7. Unstable angina

8. Chronic/acute otitis media/sinusitis

9. Major tympanic membrane trauma

10. Severe kyphoscoliosis

11. Prior chemotherapy with Bleomycin and evidence of deterioration in diffusion capacity
of the lung for carbon monoxide (DLCO) after a single hyperbaric oxygen exposure

12. History of renal insufficiency or glomerular filtration rate (GFR)< 30

13. Women that are currently pregnant or breast feeding or intend on becoming pregnant
while enrolled in the study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

RheumatoId Arthritis

Intervention(s)

Device: Hyperbaric Oxygen

Primary Outcome(s)

MRI - Bone Erosion, Combined Score (CS), Right, 3 Months [Time Frame: 3 months]

MRI - Oedema, Combined Score (CS), Right, 3 Months [Time Frame: 3 months]

Sleep Quality - Night Pain, 6 Weeks [Time Frame: 6 weeks]

DAS28 - Global Health (GH), 6 Months [Time Frame: 6 months]

MRI - Bone Erosion, Combined Score (CS), Left, 6 Months [Time Frame: 6 months]

MRI - Bone Erosion, Combined Score (CS), Right, 6 Months [Time Frame: 6 months]

MRI - Synovitis, Combined Score (CS), Right, 3 Months [Time Frame: 3 months]

Sleep Quality - Night Pain, 6 Months [Time Frame: 6 months]

Sleep Quality - Trouble Falling Asleep, 6 Weeks [Time Frame: 6 weeks]

Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months [Time Frame: 3 months]

DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months [Time Frame: 3 months]

DAS28 - Global Health (GH), 3 Months [Time Frame: 3 months]

MRI - Synovitis, Combined Score (CS), Left, 3 Months [Time Frame: 3 months]

RAPID 3 - Cumulative Scores, 6 Weeks [Time Frame: 6 weeks]

RAPID 3 - Weighed Scores, 6 Weeks [Time Frame: 6 weeks]

Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months [Time Frame: 6 months]

MRI - Synovitis, Combined Score (CS), Left, 6 Months [Time Frame: 6 months]

MRI - Synovitis, Combined Score (CS), Right, 6 Months [Time Frame: 6 months]

RAPID 3 - Abilities, 6 Weeks [Time Frame: 6 weeks]

RAPID 3 - Illness/Health, 6 Months [Time Frame: 6 months]

RAPID 3 - Pain, 6 Months [Time Frame: 6 months]

Sleep Quality - Morning Pain, 6 Months [Time Frame: 6 months]

Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months [Time Frame: 6 months]

Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months [Time Frame: 3 months]

MRI - Oedema, Combined Score (CS), Left, 6 Months [Time Frame: 6 months]

MRI - Oedema, Combined Score (CS), Right, 6 Months [Time Frame: 6 months]

RAPID 3 - Illness/Health, 6 Weeks [Time Frame: 6 weeks]

RAPID 3 - Weighed Scores, 6 Months [Time Frame: 6 months]

MRI - Oedema, Combined Score (CS), Left, 3 Months [Time Frame: 3 months]

Sleep Quality - Trouble Falling Asleep, 6 Months [Time Frame: 6 months]

DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months [Time Frame: 6 months]

RAPID 3 - Abilities, 6 Months [Time Frame: 6 months]

RAPID 3 - Cumulative Scores, 6 Months [Time Frame: 6 months]

DAS28 - C-reactive Protein (CRP), 3 Months [Time Frame: 3 months]

DAS28 - C-reactive Protein (CRP), 6 Months [Time Frame: 6 months]

MRI - Bone Erosion, Combined Score (CS), Left, 3 Months [Time Frame: 3 months]

RAPID 3 - Pain, 6 Weeks [Time Frame: 6 weeks]

Sleep Quality - Morning Pain, 6 Weeks [Time Frame: 6 weeks]

VAS Pain Scale - 6 Months [Time Frame: 6 months]

VAS Pain Scale - 6 Weeks [Time Frame: 6 weeks]

Secondary ID(s)

FDG20160004H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02984943