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| Name | Class |
|---|---|
| University of Malaga | OTHER |
| Rotterdam University of Applied Sciences | OTHER |
| University of Southern Denmark | OTHER |
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The purpose of this study is to evaluate a) the feasibility of applying a painful exercise program in the treatment of subacromial shoulder pain and b) the time needed to collect clinical outcomes for a future randomized controlled trial.
Exercise therapy is the first choice of treatment in the management of subacromial shoulder pain (SSP). Guidelines suggest active rehabilitation program for at least three months and existing research highlights the importance of progressive loaded exercise therapy at higher dosage. However, it is not clear which is the best type of exercise and if pain should be provoked during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim of the future randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program. Since the intervention consists in painful exercises, it is essential to test the rate of adherence in the intervention group (both during physiotherapist-led session and home-based exercises). Moreover, the practicability of clinical questionnaire via online survey will be tested and the time needed to collect clinical data will be calculated as well. Furthermore, feedback from physiotherapists and participants will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Painful exercises | Experimental | The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise therapy (exercising into pain) | Other | The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adherence (Physiotherapy Session) | It is analysed in terms of attendance to the physiotherapist-led sessions. Good level of adherence is defined by attendance of 7/9 (78%) of physiotherapist led-sessions | measurement every session, final measure at the end of 12 weeks |
| Rate of Adherence (Adherence Home Exercises) | It is analysed in terms of adherence to home exercises. Good level of adherence is achieved when patients completed at least 22 of 27 (81%) sessions. One session of non-supervised (home) exercise was considered completed when at least 80% of the total amount of sets and repetitions were executed as prescribed by the physiotherapist. | measurement every home exercise session, final measure at the end of 12 weeks |
| Shoulder Pain and Disability Index (SPADI) | There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome. | value at baseline minus value at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fear-Avoidance Beliefs Questionnaire (FABQ-PA) | Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs | value at baseline minus value at 12 weeks |
| Fear-Avoidance Beliefs Questionnaire (FABQ-W) |
| Measure | Description | Time Frame |
|---|---|---|
| Acromiohumeral Distance (AHD) | It is measured with the Ultrasound machine at rest and at 60 degrees of elevation in the scapular plane. (in millimeters) | value at baseline minus value at 12 weeks |
| Supraspinatus Tendon Thickness (STT) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filip Struyf, Professor | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiotherapy private practices | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37802620 | Result | Cavaggion C, Juul-Kristensen B, Luque-Suarez A, Voogt L, Wollants G, O Conaire E, Struyf F. Exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study. BMJ Open. 2023 Oct 6;13(10):e070698. doi: 10.1136/bmjopen-2022-070698. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Painful Exercises | The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Painful Exercises | The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Adherence (Physiotherapy Session) | It is analysed in terms of attendance to the physiotherapist-led sessions. Good level of adherence is defined by attendance of 7/9 (78%) of physiotherapist led-sessions | Posted | Count of Participants | Participants | measurement every session, final measure at the end of 12 weeks |
|
12 weeks
Description of other (non-serious) adverse effects monitored during the study: when patients were leaving the study because of treatment-related reasons.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Painful Exercises | The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy. |
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Limitations of the feasibility study are specified in the published article
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Filip Struyf | University of Antwerp | 32652783 | 0032 | filip.struyf@uantwerpen.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2022 | Oct 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Prospective single-group study design
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|
Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs |
| value at baseline minus value at 12 weeks |
| Fear of Pain Questionnaire (FPQ-9) | It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45. Higher scores indicate more fear and anxiety associated with pain. | value at baseline minus value at 12 weeks |
| Passive Range of Motion (ROM) in External Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | value at 12 weeks minus baseline |
| Passive ROM in Internal Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | value at 12 weeks minus baseline |
| Passive ROM in Scaption | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | value at 12 weeks minus baseline |
| Active ROM in External Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | value at 12 weeks minus baseline |
| Active ROM in Internal Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | value at 12 weeks minus baseline |
| Active ROM in Scaption | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | value at 12 weeks minus baseline |
| Maximum Voluntary Contraction (MVC) in External Rotation | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. | value at 12 weeks minus value at baseline |
| MVC in Internal Rotation | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. | values at 12 weeks minus values at baseline |
| MVC in Scaption | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. | values at 12 weeks minus baseline |
It is measured with the Ultrasound machine in the Crass position (in millimeters)
| value at baseline minus value at 12 weeks |
| Global Perceived Effect - Recovery (GPE-R) | The Global Perceived Effect (GPE) of recovery was measured after 1 week of treatment, at 6 week and at 12 weeks with the question: "To what extent do you feel recovered compared to the beginning of the treatment?" (from 1=very much better to 7=very much worse). Higher scores indicate worse outcome. | value at baseline minus value at 12 weeks |
| Global Perceived Effect - Satisfaction (GPE-S) | The Global Perceived Effect (GPE) of satisfaction was measured after 1 week of treatment, at 6 week and at 12 weeks with the question "To what extend are you satisfied about your treatment?" (from 1=absolutely satisfied to 7=absolutely dissatisfied). Higher scores indicate worse outcome. | value at baseline minus value at 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| duration of symptoms | Median | Inter-Quartile Range | months |
|
| dominant side affected | Count of Participants | Participants |
|
| previous treatment | Count of Participants | Participants |
|
|
|
| Primary | Rate of Adherence (Adherence Home Exercises) | It is analysed in terms of adherence to home exercises. Good level of adherence is achieved when patients completed at least 22 of 27 (81%) sessions. One session of non-supervised (home) exercise was considered completed when at least 80% of the total amount of sets and repetitions were executed as prescribed by the physiotherapist. | Posted | Count of Participants | Participants | measurement every home exercise session, final measure at the end of 12 weeks |
|
|
|
| Primary | Shoulder Pain and Disability Index (SPADI) | There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome. | Posted | Median | Full Range | score on a scale | value at baseline minus value at 12 weeks |
|
|
|
| Secondary | Fear-Avoidance Beliefs Questionnaire (FABQ-PA) | Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs | Posted | Median | Full Range | score on a scale | value at baseline minus value at 12 weeks |
|
|
|
| Secondary | Fear-Avoidance Beliefs Questionnaire (FABQ-W) | Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs | Posted | Median | Full Range | score on a scale | value at baseline minus value at 12 weeks |
|
|
|
| Secondary | Fear of Pain Questionnaire (FPQ-9) | It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45. Higher scores indicate more fear and anxiety associated with pain. | Posted | Median | Full Range | score on a scale | value at baseline minus value at 12 weeks |
|
|
|
| Secondary | Passive Range of Motion (ROM) in External Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | Data on passive ROM in external rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | degrees | value at 12 weeks minus baseline |
|
|
|
| Secondary | Passive ROM in Internal Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | Data on passive ROM in internal rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | degrees | value at 12 weeks minus baseline |
|
|
|
| Secondary | Passive ROM in Scaption | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | Data on passive ROM in scaption were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | degrees | value at 12 weeks minus baseline |
|
|
|
| Secondary | Active ROM in External Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | Data on active ROM in external rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | degrees | value at 12 weeks minus baseline |
|
|
|
| Secondary | Active ROM in Internal Rotation | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | Data on active ROM in internal rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | degrees | value at 12 weeks minus baseline |
|
|
|
| Secondary | Active ROM in Scaption | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. | Data on active ROM in scaption were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | degrees | value at 12 weeks minus baseline |
|
|
|
| Secondary | Maximum Voluntary Contraction (MVC) in External Rotation | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. | Data on MVC in external rotation were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is not possible to present change between baseline and 12 weeks for 6 patients. | Posted | Median | Full Range | Newtons | value at 12 weeks minus value at baseline |
|
|
|
| Secondary | MVC in Internal Rotation | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. | Data on MVC in internal rotation were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is not possible to present change between baseline and 12 weeks for 6 patients. | Posted | Median | Full Range | Newtons | values at 12 weeks minus values at baseline |
|
|
|
| Secondary | MVC in Scaption | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. | Data on MVC in scaption were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients), while one value was lost because of an error during the measurement process. Therefore, it is possible to present change between baseline and 12 weeks only for 5 patients. | Posted | Median | Full Range | Newtons | values at 12 weeks minus baseline |
|
|
|
| Other Pre-specified | Acromiohumeral Distance (AHD) | It is measured with the Ultrasound machine at rest and at 60 degrees of elevation in the scapular plane. (in millimeters) | Data on ultrasonographic measures were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | millimeters | value at baseline minus value at 12 weeks |
|
|
|
| Other Pre-specified | Supraspinatus Tendon Thickness (STT) | It is measured with the Ultrasound machine in the Crass position (in millimeters) | Data on ultrasonographic measures were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients. | Posted | Median | Full Range | millimeters | value at baseline minus value at 12 weeks |
|
|
|
| Other Pre-specified | Global Perceived Effect - Recovery (GPE-R) | The Global Perceived Effect (GPE) of recovery was measured after 1 week of treatment, at 6 week and at 12 weeks with the question: "To what extent do you feel recovered compared to the beginning of the treatment?" (from 1=very much better to 7=very much worse). Higher scores indicate worse outcome. | Posted | Median | Full Range | score on a scale | value at baseline minus value at 12 weeks |
|
|
|
| Other Pre-specified | Global Perceived Effect - Satisfaction (GPE-S) | The Global Perceived Effect (GPE) of satisfaction was measured after 1 week of treatment, at 6 week and at 12 weeks with the question "To what extend are you satisfied about your treatment?" (from 1=absolutely satisfied to 7=absolutely dissatisfied). Higher scores indicate worse outcome. | Posted | Median | Full Range | score on a scale | value at baseline minus value at 12 weeks |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |