Trial Outcomes & Findings for The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis (NCT NCT02984943)

NCT ID: NCT02984943

Last Updated: 2020-03-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2020-03-24

Participant Flow

Participant milestones

Measure	Hyperbaric Oxygen Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Hyperbaric Oxygen Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1

Baseline Characteristics

3 participant withdrew 1 physician decision

Baseline characteristics by cohort

Measure	Hyperbaric Oxygen n=10 Participants Hyperbaric Oxygen: 30 treatments of Hyperbaric Oxygen.
Age, Customized Age >/= 18	66.3 years STANDARD_DEVIATION 4.4 • n=5 Participants • 3 participant withdrew 1 physician decision
Sex: Female, Male Female	7 Participants n=5 Participants • 3 participant withdrew 1 physician decision
Sex: Female, Male Male	3 Participants n=5 Participants • 3 participant withdrew 1 physician decision
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants • 3 participants withdrew 1 physician decision
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants • 3 participants withdrew 1 physician decision
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants • 3 participants withdrew 1 physician decision
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants • 3 participants withdrew 1 physician decision
Diagnosed with rheumatoid arthritis meeting ACR/EULAR 2010 classification and 1 other criteria	10 Participants n=5 Participants • 3 participants withdrew 1 physician decision

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
Sleep Quality - Trouble Falling Asleep, 6 Weeks	1.3 score on a scale Interval 0.5 to 2.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
Sleep Quality - Trouble Falling Asleep, 6 Months	0.9 score on a scale Interval 0.5 to 3.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
Sleep Quality - Morning Pain, 6 Weeks	1.1 score on a scale Interval 0.3 to 1.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
Sleep Quality - Morning Pain, 6 Months	0.8 score on a scale Interval 0.0 to 5.2

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
Sleep Quality - Night Pain, 6 Weeks	1.1 score on a scale Interval 0.5 to 2.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
Sleep Quality - Night Pain, 6 Months	1.2 score on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
DAS28 - Global Health (GH), 3 Months	30 score on a scale Interval 15.0 to 50.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
DAS28 - Global Health (GH), 6 Months	30 score on a scale Interval 10.0 to 50.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
DAS28 - C-reactive Protein (CRP), 3 Months	3.1 score on a scale Interval 2.3 to 4.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
DAS28 - C-reactive Protein (CRP), 6 Months	3.1 score on a scale Interval 2.2 to 3.8

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months	4.1 score on a scale Interval 2.3 to 4.8

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months	3.8 score on a scale Interval 3.0 to 3.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Abilities, 6 Weeks	1.5 score on a scale Interval 0.0 to 2.7

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Abilities, 6 Months	1.9 score on a scale Interval 0.7 to 2.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Pain, 6 Weeks	2.5 score on a scale Interval 0.5 to 3.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Pain, 6 Months	2.3 score on a scale Interval 0.5 to 4.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Illness/Health, 6 Weeks	3.3 score on a scale Interval 0.5 to 5.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Illness/Health, 6 Months	3.5 score on a scale Interval 1.0 to 4.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Cumulative Scores, 6 Weeks	8.4 score on a scale Interval 2.7 to 9.8

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Cumulative Scores, 6 Months	8.5 score on a scale Interval 2.0 to 12.2

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Weighed Scores, 6 Weeks	2.9 score on a scale Interval 1.0 to 3.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
RAPID 3 - Weighed Scores, 6 Months	2.7 score on a scale Interval 0.7 to 4.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
VAS Pain Scale - 6 Weeks	2.1 score on a scale Interval 0.825 to 2.925

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Hyperbaric Oxygen n=10 Participants 30 treatments of Hyperbaric Oxygen.
VAS Pain Scale - 6 Months	2.5 score on a scale Interval 0.625 to 3.5

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Synovitis, Combined Score (CS), Right, 3 Months Improvement	1 Participants
MRI - Synovitis, Combined Score (CS), Right, 3 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Synovitis, Combined Score (CS), Right, 6 Months Improvement	0 Participants
MRI - Synovitis, Combined Score (CS), Right, 6 Months Without Improvement	9 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Synovitis, Combined Score (CS), Left, 3 Months Improvement	1 Participants
MRI - Synovitis, Combined Score (CS), Left, 3 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Synovitis, Combined Score (CS), Left, 6 Months Improvement	2 Participants
MRI - Synovitis, Combined Score (CS), Left, 6 Months Without Improvement	7 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Bone Erosion, Combined Score (CS), Right, 3 Months Improvement	9 Participants
MRI - Bone Erosion, Combined Score (CS), Right, 3 Months Without Improvement	0 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Bone Erosion, Combined Score (CS), Right, 6 Months Improvement	9 Participants
MRI - Bone Erosion, Combined Score (CS), Right, 6 Months Without Improvement	0 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Bone Erosion, Combined Score (CS), Left, 3 Months Improvement	9 Participants
MRI - Bone Erosion, Combined Score (CS), Left, 3 Months Without Improvement	0 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Bone Erosion, Combined Score (CS), Left, 6 Months Improvement	9 Participants
MRI - Bone Erosion, Combined Score (CS), Left, 6 Months Without Improvement	0 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Oedema, Combined Score (CS), Left, 3 Months Improvement	1 Participants
MRI - Oedema, Combined Score (CS), Left, 3 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Oedema, Combined Score (CS), Left, 6 Months Improvement	1 Participants
MRI - Oedema, Combined Score (CS), Left, 6 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Oedema, Combined Score (CS), Right, 3 Months Improvement	0 Participants
MRI - Oedema, Combined Score (CS), Right, 3 Months Without Improvement	9 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
MRI - Oedema, Combined Score (CS), Right, 6 Months Improvement	0 Participants
MRI - Oedema, Combined Score (CS), Right, 6 Months Without Improvement	9 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months Improvement	1 Participants
Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months Improvement	1 Participants
Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months Improvement	1 Participants
Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months Without Improvement	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 10 participants imaged. 1 unable to analyze due to fusion on imaging.

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

Outcome measures

Measure	Hyperbaric Oxygen n=9 Participants 30 treatments of Hyperbaric Oxygen.
Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months Improvement	1 Participants
Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months Without Improvement	8 Participants

Adverse Events

Hyperbaric Oxygen

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hyperbaric Oxygen n=10 participants at risk 30 treatments of Hyperbaric Oxygen.
Skin and subcutaneous tissue disorders Diffuse pruritus & popular rash	10.0% 1/10 • Number of events 1 • through study completion, an average of 6 months
Musculoskeletal and connective tissue disorders Left knee pain	10.0% 1/10 • Number of events 1 • through study completion, an average of 6 months
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease (ILD)	10.0% 1/10 • Number of events 1 • through study completion, an average of 6 months

Additional Information

Dr. Michelle Sit

David Grant Medical Center, Travis Air Force Base

Phone: 707-423-3875

Email: michelle.t.sit.mil@mail.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place