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The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02984943
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : February 17, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Michelle Sit, MD, 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
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
Actual Study Start Date : January 19, 2017
Actual Primary Completion Date : April 10, 2019
Actual Study Completion Date : April 10, 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. Sleep Quality - Trouble Falling Asleep, 6 Weeks [ Time Frame: 6 weeks ]
    The Pain Sleep Quality (PSQ)-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you had trouble falling asleep because of pain?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0" is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 weeks

  2. Sleep Quality - Trouble Falling Asleep, 6 Months [ Time Frame: 6 months ]
    The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you had trouble falling asleep because of pain?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months.

  3. Sleep Quality - Morning Pain, 6 Weeks [ Time Frame: 6 weeks ]
    The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the morning?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  4. Sleep Quality - Morning Pain, 6 Months [ Time Frame: 6 months ]
    The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the morning?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  5. Sleep Quality - Night Pain, 6 Weeks [ Time Frame: 6 weeks ]
    The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the night?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  6. Sleep Quality - Night Pain, 6 Months [ Time Frame: 6 months ]
    The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question "How often have you been awakened by pain during the night?" by placing a slash (/) on a 10 cm line directly beneath the question. The line will have "never" and "always" at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  7. DAS28 - Global Health (GH), 3 Months [ Time Frame: 3 months ]
    DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm."0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months

  8. DAS28 - Global Health (GH), 6 Months [ Time Frame: 6 months ]
    DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm. "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months

  9. DAS28 - C-reactive Protein (CRP), 3 Months [ Time Frame: 3 months ]
    DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months

  10. DAS28 - C-reactive Protein (CRP), 6 Months [ Time Frame: 6 months ]
    DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of wellbeing (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months

  11. DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months [ Time Frame: 3 months ]
    DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months

  12. DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months [ Time Frame: 6 months ]
    DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). "0"is a better outcome, and "100" is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months

  13. RAPID 3 - Abilities, 6 Weeks [ Time Frame: 6 weeks ]
    A questionnaire that assesses abilities on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks.

  14. RAPID 3 - Abilities, 6 Months [ Time Frame: 6 months ]
    A questionnaire that assesses abilities on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  15. RAPID 3 - Pain, 6 Weeks [ Time Frame: 6 weeks ]
    A questionnaire that assesses pain on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  16. RAPID 3 - Pain, 6 Months [ Time Frame: 6 months ]
    A questionnaire that assesses pain on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  17. RAPID 3 - Illness/Health, 6 Weeks [ Time Frame: 6 weeks ]
    A questionnaire that assesses illness/health on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  18. RAPID 3 - Illness/Health, 6 Months [ Time Frame: 6 months ]
    A questionnaire that assesses illness/health on a scale of 0-10. "0"is a better outcome, and "10" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  19. RAPID 3 - Cumulative Scores, 6 Weeks [ Time Frame: 6 weeks ]
    The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. "0"is a better outcome, and "30" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  20. RAPID 3 - Cumulative Scores, 6 Months [ Time Frame: 6 months ]
    The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. "0"is a better outcome, and "30" is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  21. RAPID 3 - Weighed Scores, 6 Weeks [ Time Frame: 6 weeks ]
    The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  22. RAPID 3 - Weighed Scores, 6 Months [ Time Frame: 6 months ]
    The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  23. VAS Pain Scale - 6 Weeks [ Time Frame: 6 weeks ]
    A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints "no pain" to "worse possible pain". "0"is a better outcome, and "10" is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks

  24. VAS Pain Scale - 6 Months [ Time Frame: 6 months ]
    A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints "no pain" to "worse possible pain". "0"is a better outcome, and "10" is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 months

  25. MRI - Synovitis, Combined Score (CS), Right, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  26. MRI - Synovitis, Combined Score (CS), Right, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  27. MRI - Synovitis, Combined Score (CS), Left, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  28. MRI - Synovitis, Combined Score (CS), Left, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  29. MRI - Bone Erosion, Combined Score (CS), Right, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  30. MRI - Bone Erosion, Combined Score (CS), Right, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  31. MRI - Bone Erosion, Combined Score (CS), Left, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  32. MRI - Bone Erosion, Combined Score (CS), Left, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. "0" is best outcome, "10"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  33. MRI - Oedema, Combined Score (CS), Left, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  34. MRI - Oedema, Combined Score (CS), Left, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  35. MRI - Oedema, Combined Score (CS), Right, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  36. MRI - Oedema, Combined Score (CS), Right, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  37. Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  38. Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the 6 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 6 months

  39. Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months [ Time Frame: 3 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered "improved" for the 3 month time point. The number of participants with "improved" scores will be added to form the total number with improvement at 3 months

  40. Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months [ Time Frame: 6 months ]
    Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. "0" is best outcome, "3"worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered "improved" for the t month time point. The number of participants with "improved" scores will be added to form the total number with improvement at t months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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

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


Locations
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United States, California
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
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Principal Investigator: Michelle T Sit, MD David Grant Medical Center. Travis AFB
  Study Documents (Full-Text)

Documents provided by Michelle Sit, MD, David Grant U.S. Air Force Medical Center:
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Michelle Sit, MD, Rheumatologist, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT02984943    
Other Study ID Numbers: FDG20160004H
First Posted: December 7, 2016    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michelle Sit, MD, David Grant U.S. Air Force Medical Center:
Rheumatoid Arthritis
Hyperbaric Oxygen
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases