A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
274
CORE Orthopedics
Encinitas, California, United States
Sierra Pacific Orthopaedic Center Medical Group
Fresno, California, United States
UHZ Sports Medicine
Coral Gables, Florida, United States
Visual Analog Scale (VAS) Pain Score (Per Protocol)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Time frame: 6 Months
Visual Analog Scale (VAS) Pain Score (As Treated)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Time frame: 6 Months
Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.
Time frame: Baseline and 6 months
Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months.
Time frame: Baseline and 6 months
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)
The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.
Time frame: Baseline and 12 weeks
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)
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Andrews Research Institute
Gulf Breeze, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Massachusetts Merdical School - Worcester
Worcester, Massachusetts, United States
Shores Rheumatology
Saint Clair Shores, Michigan, United States
Insall Scott Kelly Institute
New York, New York, United States
Tulsa Bone and Joint
Tulsa, Oklahoma, United States
University Orthopedics Center
State College, Pennsylvania, United States
...and 3 more locations
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. The difference in pain was calculated as visit score - baseline score.
Time frame: Baseline and 12 weeks
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)
The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.
Time frame: Baseline and 12 weeks
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)
The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.
Time frame: Baseline and 12 weeks
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)
The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.
Time frame: Baseline and 6 months
American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)
The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score. The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function.
Time frame: Baseline and 6 months
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)
The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score.
Time frame: Baseline and 12 weeks
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)
The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score.
Time frame: Baseline and 12 weeks
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)
The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score.
Time frame: Baseline and 6 months
Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)
The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help. Scoring instructions: The scores from both dimensions are averaged to derive a total score.
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)
The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)
The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)
The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)
The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)
The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)
The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 12 weeks
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)
The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 6 months
12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)
The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score. The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Baseline and 6 months