Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in symptoms and functional limitations from baseline to 3 weeks: QuickDASH |
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability). |
0 and 3 weeks |
|
Primary |
Change in symptoms and functional limitations from baseline to 6 weeks: QuickDASH |
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability). |
0 and 6 weeks |
|
Primary |
Change in symptoms and functional limitations from baseline to 12 weeks: QuickDASH |
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability). |
0 and 12 weeks |
|
Primary |
Change in symptoms and functional limitations from baseline to 24 weeks: QuickDASH |
The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability). |
0 and 24 weeks |
|
Secondary |
Change in symptoms and functional limitations from baseline to 3 weeks: WORC (Western Ontario Rotator Cuff Index) |
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level. |
0 and 3 weeks |
|
Secondary |
Change in symptoms and functional limitations from baseline to 6 weeks: WORC |
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level. |
0 and 6 weeks |
|
Secondary |
Change in symptoms and functional limitations from baseline to 12 weeks: WORC |
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level. |
0 and 12 weeks |
|
Secondary |
Change in symptoms and functional limitations from baseline to 24 weeks: WORC |
The WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. Each question uses a visual analogue scale representing a 100 point scale (0-100). Maximum score is 2100 and minimum is 0. Total score is reported as a percentage where 0% represents lowest functional status level and 100% represents the highest level. |
0 and 24 weeks |
|
Secondary |
Change in pain from baseline to 3 weeks: BPI-SF (Brief Pain Inventory-Short Form) |
The BPI-SF is a validated 9 item self-administred questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale. |
0 and 3 weeks |
|
Secondary |
Change in pain from baseline to 6 weeks: BPI-SF |
The BPI-SF is a validated 9 item self-administered questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale. |
0 and 6 weeks |
|
Secondary |
Change in pain from baseline to 12 weeks: BPI-SF |
The BPI-SF is a validated 9 item self-administered questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale. |
0 and 12 weeks |
|
Secondary |
Change in pain from baseline to 24 weeks: BPI-SF |
The BPI-SF is a validated 9 item self-administered questionnaire used to assess the intensity of pain and the interference of the pain on the patient's life. Each item is scored on a 10-point Likert scale. |
0 and 24 weeks |
|
Secondary |
Change in kinesiophobia from baseline to 3 weeks: TSK (Tampa Scale of Kinesiophobia) |
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia). |
0 and 3 weeks |
|
Secondary |
Change in kinesiophobia from baseline to 6 weeks: TSK (Tampa Scale of Kinesiophobia) |
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia). |
0 and 6 weeks |
|
Secondary |
Change in kinesiophobia from baseline to 12 weeks: TSK (Tampa Scale of Kinesiophobia) |
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia). |
0 and 12 weeks |
|
Secondary |
Change in kinesiophobia from baseline to 24 weeks: TSK (Tampa Scale of Kinesiophobia) |
The Tampa Scale of Kinesiophobia (TSK) is a 17 item self-administered questionnaire that measures beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided. It uses a 4-point Likert scale and total score ranges from 17 (lowest degree of kinesiophobia) to 68 (highest degree of kinesiophobia). |
0 and 24 weeks |
|
Secondary |
Change in pain catastrophization from baseline to 3 weeks: PCS (Pain Catastrophizing Scale) |
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum). |
0 and 3 weeks |
|
Secondary |
Change in pain catastrophization from baseline to 6 weeks: PCS (Pain Catastrophizing Scale) |
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum). |
0 and 6 weeks |
|
Secondary |
Change in pain catastrophization from baseline to 12 weeks: PCS (Pain Catastrophizing Scale) |
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum). |
0 and 12 weeks |
|
Secondary |
Change in pain catastrophization from baseline to 24 weeks: PCS (Pain Catastrophizing Scale) |
The Pain Catastrophizing Scale (PCS) is a 13 item self-administered questionnaire measuring the range of catastrophic thoughts and feelings (magnified threat, ruminating thoughts and feelings of helplessness) associated with pain that individuals may experience. Items are scored on a scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 (minimum) to 52 (maximum). |
0 and 24 weeks |
|
Secondary |
Change in ultrasonographic measurement of acromiohumeral distance from baseline to 12 weeks |
US images of AHD will be obtained with the participants seated in a standardized position with the arm at rest and at 60° of active abduction. US measures will be obtained by placing the transducer on the anterior aspect of the lateral surface of acromion along the longitudinal axis of the humerus in a frontal plane. The AHD will be measured using the build-in electronic caliper option by manually locating the superior aspect of the humeral head and the inferior aspect of acromion and then measuring the shortest linear distance between those two landmarks. For each upper limb position, three measurements will be taken. |
0 and 12 weeks |
|
Secondary |
Change in ultrasonographic measurement of supraspinatus tendon thickness from baseline to 12 weeks |
Thickness of the supraspinatus (SS) tendon will be obtained with the medial aspect of the wrist against the ipsilateral anterior superior iliac spine. Measures will be obtained with the transducer perpendicularly, one centimeter behind to the anterolateral aspect of the surface of the acromion. The thickness of the SS tendon borders will be defined inferiorly as the first hyperechoic region above the anechoic articular cartilage of the humeral head, and the hyperechoic superior border of the tendon before the anechoic subdeltoid bursa. |
0 and 12 weeks |
|
Secondary |
Change in ultrasonographic measurement of infraspinatus tendon thickness from baseline to 12 weeks |
Infraspinatus tendon thickness will be measured at the level of the posterior border of the acromion with the hand placed on the opposite shoulder. |
0 and 12 weeks |
|