Shoulder Impingement Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERExercise 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.
Sponsors
University of Malaga
Rotterdam University of Applied Sciences
University of Southern Denmark
Universiteit Antwerpen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective single-group study design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Shoulder pain for at least 3 months * Pain in the antero-lateral shoulder region * At least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc between 60° and 120°, external resistance test * Resting pain should be at 2/10 maximum on verbal NRS scale * All types of occupations were included: students, workers (including overhead workers or heavy duty workers), people on sick leave and retired people
Exclusion criteria
* Bilateral shoulder pain * Corticosteroid injections 6 weeks prior to the study * Pregnancy, inability to understand spoken or written Dutch * Clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test) * Evidence of adhesive capsulitis (50% or more than 30° loss of passive external rotation) * Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder * Symptoms of cervical radiculopathy as primary complaint (tingling, radiating pain in the arm associated with neck complaints) * Primary diagnosis of acromioclavicular pathology, shoulder instability * A radiologically confirmed fracture or presence of calcification larger than 5 mm * Presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy) * More than 4h of training in sport overhead shoulder activities per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adherence (Physiotherapy Session) | measurement every session, final measure at the end of 12 weeks | 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 |
| Shoulder Pain and Disability Index (SPADI) | value at baseline minus value at 12 weeks | 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. |
| Rate of Adherence (Adherence Home Exercises) | measurement every home exercise session, final measure at the end of 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active ROM in Scaption | value at 12 weeks minus baseline | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. |
| Fear-Avoidance Beliefs Questionnaire (FABQ-PA) | value at baseline minus value at 12 weeks | Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs |
| Fear-Avoidance Beliefs Questionnaire (FABQ-W) | value at baseline minus value at 12 weeks | Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs |
| Fear of Pain Questionnaire (FPQ-9) | value at baseline minus value at 12 weeks | 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. |
| Active ROM in External Rotation | value at 12 weeks minus baseline | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. |
| Active ROM in Internal Rotation | value at 12 weeks minus baseline | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. |
| Passive ROM in Scaption | value at 12 weeks minus baseline | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. |
| Maximum Voluntary Contraction (MVC) in External Rotation | value at 12 weeks minus value at baseline | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. |
| MVC in Internal Rotation | values at 12 weeks minus values at baseline | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. |
| MVC in Scaption | values at 12 weeks minus baseline | It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength. |
| Passive Range of Motion (ROM) in External Rotation | value at 12 weeks minus baseline | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. |
| Passive ROM in Internal Rotation | value at 12 weeks minus baseline | It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acromiohumeral Distance (AHD) | value at baseline minus value at 12 weeks | It is measured with the Ultrasound machine at rest and at 60 degrees of elevation in the scapular plane. (in millimeters) |
| Global Perceived Effect - Satisfaction (GPE-S) | value at baseline minus value at 12 weeks | 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. |
| Global Perceived Effect - Recovery (GPE-R) | value at baseline minus value at 12 weeks | 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. |
| Supraspinatus Tendon Thickness (STT) | value at baseline minus value at 12 weeks | It is measured with the Ultrasound machine in the Crass position (in millimeters) |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Covid-19 pandemic | 4 |
Baseline characteristics
| Characteristic | Painful Exercises | — |
|---|---|---|
| Age, Continuous | 50.5 years | — |
| Body Mass Index | 23.2 kg/m^2 | — |
| dominant side affected | 7 Participants | — |
| duration of symptoms | 6.5 months | — |
| previous treatment | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: measurement every home exercise session, final measure at the end of 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Painful Exercises | Rate of Adherence (Adherence Home Exercises) | 4 Participants |
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
Time frame: measurement every session, final measure at the end of 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Painful Exercises | Rate of Adherence (Physiotherapy Session) | 7 Participants |
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.
Time frame: value at baseline minus value at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Shoulder Pain and Disability Index (SPADI) | 29.3 score on a scale |
Secondary
Active ROM in External Rotation
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Time frame: value at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Active ROM in External Rotation | 6 degrees |
Secondary
Active ROM in Internal Rotation
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Time frame: value at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Active ROM in Internal Rotation | -4 degrees |
Secondary
Active ROM in Scaption
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Time frame: value at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Active ROM in Scaption | 24 degrees |
Secondary
Fear-Avoidance Beliefs Questionnaire (FABQ-PA)
Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs
Time frame: value at baseline minus value at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Fear-Avoidance Beliefs Questionnaire (FABQ-PA) | 1.5 score on a scale |
Secondary
Fear-Avoidance Beliefs Questionnaire (FABQ-W)
Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs
Time frame: value at baseline minus value at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Fear-Avoidance Beliefs Questionnaire (FABQ-W) | 3 score on a scale |
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.
Time frame: value at baseline minus value at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Fear of Pain Questionnaire (FPQ-9) | 0 score on a scale |
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.
Time frame: value at 12 weeks minus value at baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Maximum Voluntary Contraction (MVC) in External Rotation | 14.55 Newtons |
Secondary
MVC in Internal Rotation
It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.
Time frame: values at 12 weeks minus values at baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | MVC in Internal Rotation | 26.64 Newtons |
Secondary
MVC in Scaption
It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.
Time frame: values at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | MVC in Scaption | 6.54 Newtons |
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.
Time frame: value at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Passive Range of Motion (ROM) in External Rotation | 4 degrees |
Secondary
Passive ROM in Internal Rotation
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Time frame: value at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Passive ROM in Internal Rotation | 1 degrees |
Secondary
Passive ROM in Scaption
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Time frame: value at 12 weeks minus baseline
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Passive ROM in Scaption | 27 degrees |
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)
Time frame: value at baseline minus value at 12 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Acromiohumeral Distance (AHD) | 0.00 millimeters |
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.
Time frame: value at baseline minus value at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Global Perceived Effect - Recovery (GPE-R) | 3 score on a scale |
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.
Time frame: value at baseline minus value at 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Global Perceived Effect - Satisfaction (GPE-S) | 1 score on a scale |
Other Pre-specified
Supraspinatus Tendon Thickness (STT)
It is measured with the Ultrasound machine in the Crass position (in millimeters)
Time frame: value at baseline minus value at 12 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Painful Exercises | Supraspinatus Tendon Thickness (STT) | -0.17 millimeters |