MUA to Treat Postoperative Stiffness After Total Knee Art... | NCT02739035

Name	Class
Knee Society	OTHER

Label	Type	Description	Intervention Names
MUA alone	No Intervention	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
MUA with dexamethasone and celecoxib	Experimental	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.	Drug: Dexamethasone Drug: Celecoxib

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	8 mg of IV dexamethasone immediately before MUA.	MUA with dexamethasone and celecoxib

Measure	Description	Time Frame
Knee Range of Motion After Manipulation Under Anesthesia	Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.	6 weeks after manipulation
Knee Range of Motion After Manipulation Under Anesthesia	Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.	1 year from the date of the manipulation

Measure	Description	Time Frame
Knee Society Functional Score	The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems. In each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems.

Name	Affiliation	Role
Abdel Matthew, M.D.	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
HipKnee Arkansas Foundation		Little Rock	Arkansas	72205	United States
Colorado Joint Replacement

Label	URL
Mayo Clinic Clinical Trials	View source

ID	Title	Description
FG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 8, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Knee Range of Motion After Manipulation Under Anesthesia

Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.

Patients who were able to complete follow-up and have range of motion measured.

Posted

Mean

Full Range

Degrees

6 weeks after manipulation

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Units	Counts
Participants	OG00053 OG00158

Title

Denominators

Categories

Title	Measurements
	OG00098.7(60 to 125) OG001101.2(75 to 124)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance. The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib.	t-test, 2 sided		0.23	Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.													Superiority	A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.

Primary

Knee Range of Motion After Manipulation Under Anesthesia

Knee range of motion after manipulation will be measured in degrees as the total arc of motion from maximum passive flexion to maximum passive extension.

Patients who were able to complete a follow-up at the 1-year mark and have knee range of motion measured.

Posted

Mean

Full Range

Degrees

1 year from the date of the manipulation

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Society Functional Score

The Knee Society Functional score was developed by the Knee Society as a method of evaluating how well a patient can use their joint. Knee function was evaluated in two categories: walking, and stair usage. Points range from 0-100. 0 = extreme problems, 100 = no problems.

In each category, points range from 0-50, where 0 = extreme problems to 50 = no problems. Total scores are 0-100 with lower scores indicating extreme knee function problems and higher scores indicating no knee function problems.

Patients who were able to complete and return KSS Functional surveys.

Posted

Mean

Standard Deviation

score on a 0-100 scale

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Society Knee Score

The Knee Society Knee Score is method of joint evaluation developed by the Knee Society to measure the condition of a patient's knee. Knee condition was evaluated in three categories: pain, range of motion, and stability. Points range from 0-100. 0 = extreme problems, 100 = no problems.

Up to 50 points for pain, 25 points for range of motion, and 25 points for stability. Deductions occur for Extension lag, flexion contracture, malalignment, and pain at rest.

Patients who were able to complete and return the KSS survey.

Posted

Mean

Standard Deviation

Score on a 0-100 scale

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Short Form Survey 12-item Version 2 (SF-12v2): Physical Health

The SF-12v2 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. Responses were scored using the SF12v2 New England Medical Center (NEMC) scoring algorithm which converts the raw score from the questionnaire into a t-score. The algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health.

Patients who were able to complete and return the Physical Health portion of the SF-12 survey.

Posted

Mean

Standard Deviation

t-score

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Short Form Survey 12-item Version 2 (SF-12v2): Mental Health

Patients who completed and returned the SF-12 survey.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, 1 Year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score

The KOOS is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.

Patients who completed the KOOS questionnaire and returned it.

Posted

Mean

Standard Deviation

Score on a scale

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score

Patients who completed the KOOS survey and returned it.

Posted

Mean

Standard Deviation

Score on a scale

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS): Activities of Daily Living (ADL) Score

Patients who completed and returned the KOOS survey.

Posted

Mean

Standard Deviation

score on a scale

6 weeks after MUA, 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Score

Patients who completed the KOOS survey and returned it.

Posted

Mean

Standard Deviation

score on a scale

6 weeks after MUA, 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Injury and Osteoarthritis Outcomes Score (KOOS): Quality of Life

Patients who completed the KOOS survey and returned it.

Posted

Mean

Standard Deviation

score on a scale

6 weeks after MUA, 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS) for Joint Replacement (JR)

KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities. Results are scored 0-100. 0 = extreme problems, 100 = no problems.

Patients who completed the KOOS JR survey and returned it.

Posted

Mean

Standard Deviation

score on a scale

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Physical Function

The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For physical function, higher scores indicate better function.

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 survey and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after the MUA, and 1 year after the MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Anxiety

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 survey and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, and 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Depression

The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For depression, lower scores indicate fewer depressive symptoms.

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 questionnaire and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, and 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Fatigue

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 survey and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, and 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Sleep Disturbance

The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For sleep disturbance, lower scores indicate less sleep disturbance.

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 survey and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, and 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Social Activities

The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For social activities, higher scores indicate a better ability to participate in social roles and activities.

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 survey and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, and 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

Secondary

PROMIS-29 Outcome Form: Pain Interference

The PROMIS-29 outcome form measures physical and mental health outcomes for patients. Patients responded to 29 questions in seven categories: physical function, pain interference, depressive symptoms, anxiety, ability to participate in social activities, and sleep disturbance. Scores were scaled so that an average healthy person would score 50 points. A higher score represents more of what is being measured. For pain interference, higher scores indicate more frequent interference in activities due to pain.

Patient questionnaire responses are scored using the PROMIS-29 scoring algorithm. Scores are scaled to a mean of 50 for a healthy reference population with a standard deviation of 10.

Patients who completed the PROMIS-29 survey and returned it.

Posted

Mean

Standard Deviation

t-score

6 weeks after MUA, 1 year after MUA

ID	Title	Description
OG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
OG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.	0	59	0	59	0	59
EG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)	0	72	0	72	1	72

ID	Term
D003907	Dexamethasone
D002123	Calcium Dobesilate
D000068579	Celecoxib

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D013450	Sulfones
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	MUA Alone	Subjects will be given manipulation under anesthesia, will fill out questionnaires about their knee and quality of life and will be followed throughout their routine follow up to assess their continued process. Subjects will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete.
BG001	MUA With Dexamethasone and Celecoxib	For subjects assigned to the MUA with anti-inflammatory medication group, an intravenous (into the vein) dose of dexamethasone will be given at the time of MUA. Subjects in this group will also receive celecoxib. They will be asked to take the medicine one time daily either at morning or night time with food and water for 2 weeks following MUA. Subjects will also be followed throughout their routine follow up to assess their continued process, and they will fill out questionnaires at the time of their consent and their 6-week and 1-year follow up visits. The questionnaires will take about 15-20 minutes to complete. Dexamethasone: 8 mg of IV dexamethasone immediately before MUA. Celecoxib: 2 weeks per mouth of celecoxib (200 mg daily)
BG002	Total	Total of all reporting groups