The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Sleep Quality - Morning Pain, 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Sleep Quality - Morning Pain, 6 Months
时间窗: 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
Sleep Quality - Trouble Falling Asleep, 6 Months
时间窗: 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.
Sleep Quality - Night Pain, 6 Weeks
时间窗: 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
DAS28 - C-reactive Protein (CRP), 3 Months
时间窗: 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
RAPID 3 - Pain, 6 Weeks
时间窗: 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
Sleep Quality - Trouble Falling Asleep, 6 Weeks
时间窗: 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
DAS28 - Global Health (GH), 3 Months
时间窗: 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
DAS28 - C-reactive Protein (CRP), 6 Months
时间窗: 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
RAPID 3 - Abilities, 6 Weeks
时间窗: 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.
Sleep Quality - Night Pain, 6 Months
时间窗: 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
DAS28 - Global Health (GH), 6 Months
时间窗: 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
RAPID 3 - Pain, 6 Months
时间窗: 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
DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months
时间窗: 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
DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months
时间窗: 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
RAPID 3 - Abilities, 6 Months
时间窗: 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
Sleep Quality - Morning Pain, 6 Weeks
时间窗: 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
RAPID 3 - Illness/Health, 6 Weeks
时间窗: 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
VAS Pain Scale - 6 Weeks
时间窗: 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
MRI - Synovitis, Combined Score (CS), Right, 3 Months
时间窗: 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
MRI - Synovitis, Combined Score (CS), Left, 3 Months
时间窗: 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
MRI - Bone Erosion, Combined Score (CS), Right, 6 Months
时间窗: 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
RAPID 3 - Weighed Scores, 6 Months
时间窗: 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
MRI - Bone Erosion, Combined Score (CS), Right, 3 Months
时间窗: 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
Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months
时间窗: 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
MRI - Synovitis, Combined Score (CS), Right, 6 Months
时间窗: 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
MRI - Oedema, Combined Score (CS), Left, 6 Months
时间窗: 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
RAPID 3 - Illness/Health, 6 Months
时间窗: 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
MRI - Synovitis, Combined Score (CS), Left, 6 Months
时间窗: 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
MRI - Bone Erosion, Combined Score (CS), Left, 6 Months
时间窗: 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
MRI - Oedema, Combined Score (CS), Right, 3 Months
时间窗: 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
MRI - Oedema, Combined Score (CS), Right, 6 Months
时间窗: 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
Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months
时间窗: 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
RAPID 3 - Cumulative Scores, 6 Weeks
时间窗: 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
RAPID 3 - Cumulative Scores, 6 Months
时间窗: 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
RAPID 3 - Weighed Scores, 6 Weeks
时间窗: 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
VAS Pain Scale - 6 Months
时间窗: 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
MRI - Oedema, Combined Score (CS), Left, 3 Months
时间窗: 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
MRI - Bone Erosion, Combined Score (CS), Left, 3 Months
时间窗: 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
Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months
时间窗: 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
Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months
时间窗: 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
次要结局
未报告次要终点
研究者
Michelle Sit, MD
Rheumatologist
David Grant U.S. Air Force Medical Center