N/A
Completed N=14
The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02984943 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Sleep Quality - Trouble Falling Asleep, 6 Weeks — 1.3 score on a scale — p=0.10
Summary
The purpose of this investigation is to determine the effects and ease of using hyperbaric oxygen therapy HBO2 for the treatment of rheumatoid arthritis joint pain and prevention of disease progression. In this study it is our intention to not only evaluate effects and ease of treatment but time, cost, possible adverse events and effect size in an attempt to predict an appropriate sample size and improve on the study design prior to a more extensive study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality - Trouble Falling Asleep, 6 Weeks |
1.3 | 0.10 |
| PRIMARY Sleep Quality - Trouble Falling Asleep, 6 Months |
0.9 | 0.10 |
| PRIMARY Sleep Quality - Morning Pain, 6 Weeks |
1.1 | 0.02 sig |
| PRIMARY Sleep Quality - Morning Pain, 6 Months |
0.8 | 0.02 sig |
| PRIMARY Sleep Quality - Night Pain, 6 Weeks |
1.1 | 0.004 sig |
| PRIMARY Sleep Quality - Night Pain, 6 Months |
1.2 | 0.004 sig |
| PRIMARY DAS28 - Global Health (GH), 3 Months |
30 | 0.2938 |
| PRIMARY DAS28 - Global Health (GH), 6 Months |
30 | 0.2938 |
| PRIMARY DAS28 - C-reactive Protein (CRP), 3 Months |
3.1 | 0.0608 |
| PRIMARY DAS28 - C-reactive Protein (CRP), 6 Months |
3.1 | 0.0608 |
| PRIMARY DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months |
4.1 | 0.1496 |
| PRIMARY DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months |
3.8 | 0.1496 |
| PRIMARY RAPID 3 - Abilities, 6 Weeks |
1.5 | 0.36 |
| PRIMARY RAPID 3 - Abilities, 6 Months |
1.9 | 0.36 |
| PRIMARY RAPID 3 - Pain, 6 Weeks |
2.5 | 0.0012 sig |
| PRIMARY RAPID 3 - Pain, 6 Months |
2.3 | 0.0012 sig |
| PRIMARY RAPID 3 - Illness/Health, 6 Weeks |
3.3 | 0.90 |
| PRIMARY RAPID 3 - Illness/Health, 6 Months |
3.5 | 0.90 |
| PRIMARY RAPID 3 - Cumulative Scores, 6 Weeks |
8.4 | 0.0068 sig |
| PRIMARY RAPID 3 - Cumulative Scores, 6 Months |
8.5 | 0.0068 sig |
| PRIMARY RAPID 3 - Weighed Scores, 6 Weeks |
2.9 | 0.0183 sig |
| PRIMARY RAPID 3 - Weighed Scores, 6 Months |
2.7 | 0.0183 sig |
| PRIMARY VAS Pain Scale - 6 Weeks |
2.1 | 0.08 |
| PRIMARY VAS Pain Scale - 6 Months |
2.5 | 0.08 |
| PRIMARY MRI - Synovitis, Combined Score (CS), Right, 3 Months |
1; 8 | — |
| PRIMARY MRI - Synovitis, Combined Score (CS), Right, 6 Months |
0; 9 | — |
| PRIMARY MRI - Synovitis, Combined Score (CS), Left, 3 Months |
1; 8 | — |
| PRIMARY MRI - Synovitis, Combined Score (CS), Left, 6 Months |
2; 7 | — |
| PRIMARY MRI - Bone Erosion, Combined Score (CS), Right, 3 Months |
9; 0 | — |
| PRIMARY MRI - Bone Erosion, Combined Score (CS), Right, 6 Months |
9; 0 | — |
| PRIMARY MRI - Bone Erosion, Combined Score (CS), Left, 3 Months |
9; 0 | — |
| PRIMARY MRI - Bone Erosion, Combined Score (CS), Left, 6 Months |
9; 0 | — |
| PRIMARY MRI - Oedema, Combined Score (CS), Left, 3 Months |
1; 8 | — |
| PRIMARY MRI - Oedema, Combined Score (CS), Left, 6 Months |
1; 8 | — |
| PRIMARY MRI - Oedema, Combined Score (CS), Right, 3 Months |
0; 9 | — |
| PRIMARY MRI - Oedema, Combined Score (CS), Right, 6 Months |
0; 9 | — |
| PRIMARY Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months |
1; 8 | — |
| PRIMARY Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months |
1; 8 | — |
| PRIMARY Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months |
1; 8 | — |
| PRIMARY Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months |
1; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18
- Active duty or Department of Defense (DoD) beneficiary
- Diagnosed with rheumatoid arthritis meeting ACR/EULAR 2010 classification criteria and any one of the following:
- Patient does not want to be on rheumatologic medications
- Patient has contraindications to standard rheumatologic medications
- Patient has failed treatment or an incomplete response with standard rheumatologic medications
- Women of childbearing age must have a negative pregnancy test and currently be on a reliable form of birth control
Exclusion Criteria
- Severe depression
- Dementia, mental disability
- Claustrophobia
- Uncontrolled seizure disorder
- Uncontrolled asthma/severe chronic obstructive pulmonary disease (COPD) with partial pressure of carbon dioxide (pCO2) > 45 mmHg on arterial blood gas
- Grade 4 congestive heart failure
- Unstable angina
- Chronic/acute otitis media/sinusitis
- Major tympanic membrane trauma
- Severe kyphoscoliosis
- Prior chemotherapy with Bleomycin and evidence of deterioration in diffusion capacity of the lung for carbon monoxide (DLCO) after a single hyperbaric oxygen exposure
- History of renal insufficiency or glomerular filtration rate (GFR)< 30
- Women that are currently pregnant or breast feeding or intend on becoming pregnant while enrolled in the study
Data sourced from ClinicalTrials.gov (NCT02984943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.