Glenohumeral Osteoarthritis
Conditions
Keywords
Orthovisc, Osteoarthritis, Shoulder, Randomized
Brief summary
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
Detailed description
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.
Interventions
DEVICEOrthovisc
Orthovisc injection
DRUGControl
Celestone (betamethasone sodium phosphate and acetate) - 2 mL
Sponsors
DePuy Mitek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A candidate for unilateral treatment of osteoarthritis of the shoulder * Have failed conservative treatment
Exclusion criteria
* Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function * No active instability or acute dislocation episodes within the previous 12 months * Known allergy to hyaluronate preparations * Pregnant or breast feeding * Is receiving prescription pain medication for conditions unrelated to the index shoulder condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score (Per Protocol) | 6 Months | 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. |
| Visual Analog Scale (VAS) Pain Score (As Treated) | 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) | Baseline and 12 weeks | The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale. |
| Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) | Baseline and 12 weeks | 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. |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) | Baseline and 12 weeks | 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. |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) | Baseline and 12 weeks | 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. |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) | Baseline and 6 months | 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. |
| American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) | Baseline and 6 months | 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. |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) | Baseline and 12 weeks | 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. |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) | Baseline and 12 weeks | 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. |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) | Baseline and 6 months | 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. |
| Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) | Baseline and 6 months | 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. |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) | Baseline and 12 weeks | 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. |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) | Baseline and 12 weeks | 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. |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) | Baseline and 6 months | 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. |
| 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) | Baseline and 6 months | 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. |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) | Baseline and 12 weeks | 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. |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) | Baseline and 12 weeks | 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. |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) | Baseline and 6 months | 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. |
| 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) | Baseline and 6 months | 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. |
| Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) | Baseline and 6 months | 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. |
| Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) | Baseline and 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Enrollment occurred between January 2007 and February 2010 at 13 sites based in the US.
Pre-assignment details
Four subjects were randomized; however due to required imaging inclusion/exclusion criteria was not met. Hence, these 4 subjects were not treated.
Participants by arm
| Arm | Count |
|---|---|
| Control Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone). | 87 |
| Investigational Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder. | 183 |
| Total | 270 |
Baseline characteristics
| Characteristic | Control | Investigational | Total |
|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 9.84 | 58.6 years STANDARD_DEVIATION 10.68 | 58.4 years STANDARD_DEVIATION 10.4 |
| Age, Customized 18 to 29 | 1 participants | 1 participants | 2 participants |
| Age, Customized 30 and 39 years | 4 participants | 11 participants | 15 participants |
| Age, Customized 40 to 49 years | 11 participants | 22 participants | 33 participants |
| Age, Customized 50 to 59 years | 22 participants | 50 participants | 72 participants |
| Age, Customized 60 to 69 years | 43 participants | 68 participants | 111 participants |
| Age, Customized 70 to 79 years | 6 participants | 31 participants | 37 participants |
| Region of Enrollment United States | 87 participants | 183 participants | 270 participants |
| Sex: Female, Male Female | 21 Participants | 44 Participants | 65 Participants |
| Sex: Female, Male Male | 66 Participants | 139 Participants | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 87 | 19 / 183 |
| serious Total, serious adverse events | 3 / 87 | 10 / 183 |
Outcome results
Primary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Visual Analog Scale (VAS) Pain Score (As Treated) | 33.196 mm on a 100 mm VAS scale | Standard Error 2.777 |
| Investigational | Visual Analog Scale (VAS) Pain Score (As Treated) | 30.406 mm on a 100 mm VAS scale | Standard Error 1.926 |
Comparison: Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.p-value: 0.4195% CI: [-9.441, 3.861]Mixed Models Repeated Measures ANCOVA
Primary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Visual Analog Scale (VAS) Pain Score (Per Protocol) | 30.389 mm on a 100 mm VAS scale | Standard Error 3.035 |
| Investigational | Visual Analog Scale (VAS) Pain Score (Per Protocol) | 28.917 mm on a 100 mm VAS scale | Standard Error 2.233 |
Comparison: Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.p-value: 0.69695% CI: [-8.888, 5.943]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) | 0.167 units on a scale | Standard Error 0.875 |
| Investigational | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated) | 0.938 units on a scale | Standard Error 0.623 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.47395% CI: [-1.339, 2.881]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) | -0.130 units on a scale | Standard Error 0.991 |
| Investigational | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol) | 1.060 units on a scale | Standard Error 0.726 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.p-value: 0.33395% CI: [-1.225, 3.604]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) | 0.330 units on a scale | Standard Error 0.897 |
| Investigational | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated) | 0.798 units on a scale | Standard Error 0.636 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.67195% CI: [-1.692, 2.627]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) | 0.397 units on a scale | Standard Error 0.941 |
| Investigational | 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol) | 0.379 units on a scale | Standard Error 0.692 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.p-value: 0.98895% CI: [-2.314, 2.278]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) | 2.179 units on a scale | Standard Error 0.877 |
| Investigational | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated) | 1.950 units on a scale | Standard Error 0.624 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.83295% CI: [-2.343, 1.887]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) | 3.607 units on a scale | Standard Error 1.05 |
| Investigational | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol) | 2.050 units on a scale | Standard Error 0.771 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.p-value: 0.23295% CI: [-4.119, 1.003]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) | 1.559 units on a scale | Standard Error 0.896 |
| Investigational | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated) | 2.779 units on a scale | Standard Error 0.635 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.26795% CI: [-0.937, 3.378]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) | 2.763 units on a scale | Standard Error 1.009 |
| Investigational | 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol) | 2.831 units on a scale | Standard Error 0.743 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.p-value: 0.95795% CI: [-2.396, 2.532]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) | 12.960 units on a scale | Standard Error 2.197 |
| Investigational | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated) | 13.988 units on a scale | Standard Error 1.605 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.70795% CI: [-4.338, 6.393]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) | 18.329 units on a scale | Standard Error 2.578 |
| Investigational | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol) | 17.397 units on a scale | Standard Error 1.917 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.77295% CI: [-7.26, 5.396]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) | 14.272 units on a scale | Standard Error 2.237 |
| Investigational | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated) | 15.402 units on a scale | Standard Error 1.636 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.68595% CI: [-4.341, 6.001]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) | 18.228 units on a scale | Standard Error 2.438 |
| Investigational | American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol) | 17.408 units on a scale | Standard Error 1.858 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.7995% CI: [-6.866, 5.227]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) | 59.7 Percentage of Participants |
| Investigational | Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated) | 54.4 Percentage of Participants |
Comparison: Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.95% CI: [-19.7, 9.1]
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) | 63.8 Percentage of Participants |
| Investigational | Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol) | 63.6 Percentage of Participants |
Comparison: Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.95% CI: [-15.6, 15.1]
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) | -11.828 units on a scale | Standard Error 2.132 |
| Investigational | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated) | -9.467 units on a scale | Standard Error 1.531 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.36995% CI: [-2.801, 7.522]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) | -17.871 units on a scale | Standard Error 2.477 |
| Investigational | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol) | -10.554 units on a scale | Standard Error 1.83 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.p-value: 0.01895% CI: [1.249, 13.386]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) | -10.314 units on a scale | Standard Error 2.179 |
| Investigational | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated) | -12.522 units on a scale | Standard Error 1.539 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.40995% CI: [-7.455, 3.039]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) | -16.109 units on a scale | Standard Error 2.39 |
| Investigational | Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol) | -13.492 units on a scale | Standard Error 1.752 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.p-value: 0.37995% CI: [-3.226, 8.46]Mixed Models Repeated Measures ANCOVA
Secondary
Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (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. The difference in pain was calculated as visit score - baseline score.
Time frame: Baseline and 12 weeks
Population: The As Treated analysis population included all subjects that received treatment and had outcome data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) | -16.882 mm on a 100 mm VAS scale | Standard Error 2.757 |
| Investigational | Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated) | -19.756 mm on a 100 mm VAS scale | Standard Error 1.909 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.39295% CI: [-9.472, 3.723]Mixed Models Repeated Measures ANCOVA
Secondary
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
Population: The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) | -23.624 mm on a 100 mm VAS scale | Standard Error 3.206 |
| Investigational | Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol) | -24.494 mm on a 100 mm VAS scale | Standard Error 2.356 |
Comparison: The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.p-value: 0.82795% CI: [-8.698, 6.957]Mixed Models Repeated Measures ANCOVA