Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
American Shoulder and Elbow Surgeons Scale (ASES) at Baseline |
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability. |
Baseline |
|
Primary |
American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks |
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability. |
3 weeks |
|
Primary |
American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks |
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability. |
12 weeks |
|
Primary |
American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months |
shoulder pain and disability; The ASES is a 100-point shoulder-specific self-report questionnaire consisting of 2 subscales including pain and disability. Lower scores are indicative of higher levels of disability. |
6 months |
|
Secondary |
Numeric Pain Rating Scale (NPRS) at Baseline |
Pain: An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain. |
Baseline |
|
Secondary |
Numeric Pain Rating Scale (NPRS) at 3 Weeks |
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain. |
3 weeks |
|
Secondary |
Numeric Pain Rating Scale (NPRS) at 12 Weeks |
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain. |
12 weeks |
|
Secondary |
Numeric Pain Rating Scale (NPRS) at 6 Months |
Pain; An 11-point NPRS will be used to measure pain intensity. Numeric pain scales have been shown to be reliable and valid.61-65 Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain. |
6 months |
|
Secondary |
DASH score at Baseline |
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability). |
Baseline |
|
Secondary |
DASH score at 3 Weeks |
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability). |
3 weeks |
|
Secondary |
DASH score at 12 Weeks |
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability). |
12 weeks |
|
Secondary |
DASH score at 6 Months |
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH);The DASH is a 30 item, self-administered questionnaire that addresses symptoms and physical function in individuals with disorders of the upper limb.51 The DASH is scored from 0-100% (0% = no disability). |
6 months |
|
Secondary |
Patient specific functional scale (PSFS) at Baseline |
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints |
Baseline |
|
Secondary |
Patient specific functional scale (PSFS) at 3 Weeks |
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints |
3 weeks |
|
Secondary |
Patient specific functional scale (PSFS) at 12 Weeks |
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints |
12 weeks |
|
Secondary |
Patient specific functional scale (PSFS) at 6 Months |
Patient assessment of function; The PSFS is a patient self-reported measurement tool used to assess functional change. Patients identify up to 5 activities at Baseline that they find difficult or impossible to perform due to their problem, and then rate the difficulty level of each activity from 0 (unable to perform) to 10 (able to perform activity at same level as before injury/problem). The sum of the 5 scores will be reported and assessed for change at subsequent timepoints |
6 months |
|
Secondary |
Global Rating of Change (GROC) at 3 Weeks |
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. |
3 weeks |
|
Secondary |
Global Rating of Change (GROC) at 12 Weeks |
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. |
12 weeks |
|
Secondary |
Global Rating of Change (GROC) at 6 Months |
Patient perceived level of change; The fifteen-point global rating scale described by Jaeschke et al. will be used.53 The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. |
6 months |
|
Secondary |
Medication Usage at Baseline |
Use of medication; medication name, dose and frequency per day/week will be tracked |
baseline |
|
Secondary |
Medication Usage at 3 Weeks |
Use of medication; medication name, dose and frequency per day/week will be tracked |
3 weeks |
|
Secondary |
Medication Usage at 12 Weeks |
Use of medication; medication name, dose and frequency per day/week will be tracked |
12 weeks |
|
Secondary |
Medication Usage at 6 Months |
Use of medication; medication name, dose and frequency per day/week will be tracked |
6 months |
|
Secondary |
Should Pain and Disability Index |
participant report of shoulder related pain and disability (how shoulder pain limits function) |
Baseline |
|
Secondary |
Should Pain and Disability Index |
participant report of shoulder related pain and disability (how shoulder pain limits function) |
3 weeks |
|
Secondary |
Should Pain and Disability Index |
participant report of shoulder related pain and disability (how shoulder pain limits function) |
12 weeks |
|
Secondary |
Should Pain and Disability Index |
participant report of shoulder related pain and disability (how shoulder pain limits function) |
6 months |
|