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The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02984943
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
David Grant U.S. Air Force Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
RheumatoId Arthritis Device: Hyperbaric Oxygen Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study
Study Start Date : November 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyperbaric Oxygen
Hyperbaric Oxygen
Device: Hyperbaric Oxygen
30 treatments of Hyperbaric Oxygen.




Primary Outcome Measures :
  1. Ultrasound measurement of joint progression alteration [ Time Frame: Baseline and 6 months ]
    Changes in the progression of joint disease as measured by ultrasound at baseline and at 6 months

  2. MRI measurement of joint progression alteration [ Time Frame: Baseline and 6 months ]
    Changes the progression of joint disease as measured by MRI at baseline and 6 months.

  3. Change in disease activity of Rheumatoid Arthritis assessed at baseline and six months [ Time Frame: Baseline and 6 months ]
    Changes in disease activity measured by disease activity monitoring score (DAS28) at baseline and at 6 months

  4. Change in sleep quality assessed at baseline and 6 months [ Time Frame: Baseline and 6 months ]
    Sleep quality as assessed by Sleep Survey at baseline and 6 months

  5. Subjective improvement in movement and activities of daily living [ Time Frame: Baseline and 6 months ]
    Subjective improvement in activities of daily living using the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) at baseline and 6 months

  6. Changes in C-reactive protein (CRP) [ Time Frame: Baseline and 6 months ]
    Changes C-reactive protein (CRP) at baseline and six months.

  7. Changes in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline and 6 months ]
    Changes in erythrocyte sedimentation rate (ESR) at baseline and 6 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18
  2. Active duty or 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 COPD with 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 GFR< 30
  13. Women that are currently pregnant or breast feeding or intend on becoming pregnant while enrolled in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984943


Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
Principal Investigator: Thomas Schmidt, MD David Grant Medical Center. Travis AFB

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT02984943     History of Changes
Other Study ID Numbers: FDG20160004H
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Grant U.S. Air Force Medical Center:
Rheumatoid Arthritis
Hyperbaric Oxygen

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases