The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study
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:
1. A visit with the rheumatologist to do routine assessments to establish baseline
measurement using the Disease Activity Scale (DAS28)
2. 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.
3. Subjective patient reporting will be captured using the Routine Assessment of Patient
Index Data (RAPID 3)
4. Sleep quality will be tracked using the Pain and Sleep Quality Questionnaire (PSQ-3).
5. Visual Analog Scores (VAS) for pain will be tracked.
6. 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.
Condition:
RheumatoId Arthritis
Treatment:
Hyperbaric Oxygen
Start Date:
January 19, 2017
Sponsor:
David Grant U.S. Air Force Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT02984943