- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984943
The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis
The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study
Study Overview
Detailed Description
Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory disorder of unknown etiology that primarily involves synovial joints, typically symmetrically. If untreated and/or uncontrolled, joint destruction due to erosion of cartilage and bone can cause joint destruction, joint deformities, loss of physical function, severe disability, and difficulties maintaining employment. American College of Rheumatology (ACR)/EULAR 2010 classification criteria is a score-based algorithm which adds scores of 4 categories including, joint involvement, serology, acute-phase reactants and duration of symptoms. A score of >6/10 is needed for classification of a patient as having definite RA.
Non-pharmacologic and supplementary therapies include patient education, rest, exercise, nutrition counseling, cardiovascular disease risk reduction, and immunizations to decrease risk of infectious complications of immunosuppression. These are important in the comprehensive management of RA in all stages of disease and are used in addition to drug therapy.
Pharmacologic therapies typically start with a disease-modifying anti-rheumatic drug (DMARD), preferably as soon as possible after diagnosis. DMARDs are commonly used in combination with anti-inflammatory drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids which are often used as bridging therapies until the DMARDs become effective. The goal is disease remission. To assess response, disease activity scores are used along with inflammatory markers.
Three patients with active RA treated in the multi-place hyperbaric facility at David Grant Medical Center (DGMC), Travis Air Force Base, California, for non RA-related indications, all noted significant improvement in arthralgias, sleep patterns and overall well-being during the course of therapy. Two were treated at 2 atmospheres absolute (ATA) oxygen for 90 minutes daily Monday through Friday. One patient received 2 ATA air on the same treatment protocol as a participant in a research study, and a subsequent course of hyperbaric oxygen (HBO2) at 2 ATA.
This is a pilot study. Patients will be recruited through the Rheumatologists, IRB-approved HIPAA waiver to contact patients that have been seen in the military treatment facility (MTF) within the past year with a diagnosis of RA, flyers in the Rheumatology Clinic or thru Commander Calls.
During the initial screening visit:
The rheumatologist will discuss the trial and at this point the subject will be consented and the inclusion/exclusion criteria will be reviewed. If subject qualifies they will see the Hyperbaric physician who will do physical examination to determine if it is safe for the subject to receive HBO2. An human chorionic gonadotrophin (HCG) by point of care testing (POCT) will be completed by the coordinator in women capable of pregnancy. After this exam is done the subject will be scheduled for a trial Hyperbaric session.
Baseline visit will be done after the subject has tolerated the trial hyperbaric session. This visit includes:
- A visit with the rheumatologist to do routine assessments to establish baseline measurement using the Disease Activity Scale (DAS28)
- Labs (CRP and Erythrocyte Sedimentation Rate (ESR), basic metabolic panel (BMP) and microparticles), will be completed. Magnetic resonance imaging (MRI) with and without contrast and ultrasound will be done on both hands from wrists to proximal phalanges the wrist. BMP is done pre-MRI to guarantee adequate kidney function.
- Subjective patient reporting will be captured using the Routine Assessment of Patient Index Data (RAPID 3)
- Sleep quality will be tracked using the Pain and Sleep Quality Questionnaire (PSQ-3).
- Visual Analog Scores (VAS) for pain will be tracked.
- Surveys will be done by a study team member
The subject at this time will be scheduled to start HBO2 treatments. Screening, baseline, first HBO2 treatment all in one month. Participants will complete 30 sessions within 10 weeks.
If the subject reports pain relief (> 40% or zero pain) during the HBO2 treatments the will be referred to the rheumatologist for assessment. Pain improvement will be based on a pain assessment (1-10 scale reported verbally) at hyperbaric treatment visits. Labs will be drawn at this time. RAPID 3, PSQ-3 and VAS will be done at least six times while undergoing HBO2 treatment to track subject progress. Labs (CRP, ESR, microparticles) will be repeated at the conclusion of the HBO2 treatments.
At the month 3 and month 6 visit (+/- 2 week window) the subject will see the rheumatologist to track disease activity using the DAS-28. The date of the visit will be scheduled for three and six months from the baseline visit. The rheumatologist will order the MRI, ultrasound and lab studies prior to the visit. RAPID 3, PSQ-3 and VAS will be administered at this time. Lab samples will be collected prior to the Rheumatology appointment.
The six month visit marks the end of the trial. Patients will continue to be followed in Rheumatology Clinic every three months.
If the patient's RA symptoms worsen during the study, the physicians will institute measures to address the cause. The medical monitor will be notified and if any adverse events are involved, they will be recorded and reported to the Institutional Review Board (IRB).
Data:
Data will be entered by authorized study personnel only. Demographic information will be collected including sex, age and ethnic background in accordance with HIPPA compliance.
Data collected during this study will be analyzed at various points in time to include physician exams, labs (CRP, ESR, BMP, analysis of microparticles, neutrophil and platelet activation), radiologic studies, joint inspection.
Changes in joint pain will be determined by self-reporting and results of the standard outcome measures questionnaires (RAPID 3, PSQ-3 and VAS). A separate sleep survey will be administered.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyperbaric Oxygen
|
30 treatments of Hyperbaric Oxygen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 weeks
|
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.
|
6 months
|
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
|
6 weeks
|
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
|
6 months
|
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 weeks
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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.
|
6 weeks
|
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
|
6 months
|
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
|
6 weeks
|
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
|
6 months
|
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
|
6 weeks
|
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
|
6 months
|
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
|
6 weeks
|
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
|
6 months
|
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
|
6 weeks
|
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
|
6 months
|
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
|
6 weeks
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
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
|
3 months
|
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
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michelle T Sit, MD, David Grant Medical Center. Travis AFB
Publications and helpful links
General Publications
- Ayearst L, Harsanyi Z, Michalko KJ. The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies. Pain Res Manag. 2012 Jul-Aug;17(4):281-90. doi: 10.1155/2012/635967.
- Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461. Erratum In: Ann Rheum Dis. 2010 Oct;69(10):1892.
- Pincus T, Swearingen C, Wolfe F. Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthritis Rheum. 1999 Oct;42(10):2220-30. doi: 10.1002/1529-0131(199910)42:103.0.CO;2-5.
- Varga OIu, Ignat'ev VK, Vezikova NN, Kheifetz IV. [Radiation-modifying effect of oxygen barotherapy in complex treatment of patients with rheumatoid arthritis and osteoarthrosis]. Ter Arkh. 2002;74(12):83-6. Russian.
- Sit MT, Schmidt TW, Edmonds LD, Kelly JA, Sky KM, Thornton JA, McNeary-Garvin AM, Thom SR, Slade JB. The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study. J Clin Rheumatol. 2021 Dec 1;27(8):e462-e468. doi: 10.1097/RHU.0000000000001540.
Helpful Links
- Hyperbaric oxygen in chronic traumatic brain injury: oxygen, pressure, and gene therapy
- Disease activity score for rheumatoid arthritis.
- Approaches to the management of rheumatoid arthritis
- The treatment of rheumatoid arthritis (RA) is directed toward the control of synovitis and the prevention of joint injury.
- 50 patients treated with traditional drug therapy with the addition of Hyperbaric Oxygen
- citation regarding hyperbaric and rheumatoid arthritis.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDG20160004H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on RheumatoId Arthritis
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Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
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Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
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AmgenTerminated
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
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AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
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National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
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University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
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University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
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Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
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Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
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Louisiana State University Health Sciences Center...U.S. Army Medical Research and Development CommandUnknownTraumatic Brain Injury | Post-Concussion SyndromeUnited States
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Hull University Teaching Hospitals NHS TrustNorth of England Medical & Hyperbaric ServicesCompletedMyocardial Reperfusion Injury | CytoprotectionUnited Kingdom
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Stanford UniversityRecruiting
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Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
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Omar AljitawiCompleted
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University of British ColumbiaUnknown
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