The aim of the 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.
Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (SSP). Guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. However, it is not clear which is the best type of exercise and if pain should be provoked or avoided 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 is to investigate if one painful exercise can give better and faster results in the management of SSP than non-painful program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale
the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)
Physiotherapy private practices
Antwerp, Belgium
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: Change from baseline to 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.
Time frame: Change from baseline to 6 months
Visual Analogue Scale (VAS)
It measures pain during activity, during night, in the past 24 hours. It is measured on a scale from 0 to 100, where 0=no pain, 100=worst imaginable pain.
Time frame: Change from baseline to 12 weeks
Visual Analogue Scale (VAS)
It measures pain at rest, during activity, during night, in the past 24 hours. It is measured on a scale from 0 to 100, where 0=no pain, 100=worst imaginable pain.
Time frame: Change from baseline to 6 months
Health-Related Quality of Life
It is measured with: 1) EQ-5D-5L (EuroQol-5 dimentions-5 levels) index: score range from less than 0 (0=value of health state equivalent to dead; negative values indicate state worse than dead) to 1 (the value of full health), with higher scores indicating higher health; 2) EQ-5D VAS (EuroQol-5 dimentions-Visual Analogue Scale), from 0 to 100 score, with 0=lowest health-related quality of life, 100=best health-related quality of life)
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Time frame: Change from baseline to 12 weeks
Health-Related Quality of Life
It is measured with: 1) EQ-5D-5L (EuroQol-5 dimentions-5 levels) index: score range from less than 0 (0=value of health state equivalent to dead; negative values indicate state worse than dead) to 1 (the value of full health), with higher scores indicating higher health; 2) EQ-5D VAS (EuroQol-5 dimentions-Visual Analogue Scale), from 0 to 100 score, with 0=lowest health-related quality of life, 100=best health-related quality of life)
Time frame: Change from baseline to 6 months
Fear-Avoidance Beliefs Questionnaire (FABQ)
It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.
Time frame: Change from baseline to 12 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
It consists of 16 items and it has 2 subscales: Physical Activity (FABQ-PA, range: 0-24) and Work (FABQ-W, range: 0-42) higher scores mean more fear avoidance beliefs affecting physical activity and/or work.
Time frame: Change from baseline to 6 months
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 mean more fear and anxiety associated with pain.
Time frame: Change from baseline to 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 mean more fear and anxiety associated with pain.
Time frame: Change from baseline to 6 months
Range of Movement (ROM) in internal rotation, external rotation, scaption
It is measured with the inclinometer. The unit of measure is degrees.
Time frame: Change from baseline to 12 weeks
Range of Movement (ROM) in internal rotation, external rotation, scaption
It is measured with the inclinometer. The unit of measure is degrees.
Time frame: Change from baseline to 6 months
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Time frame: Change from baseline to 12 weeks
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Time frame: Change from baseline to 6 months
Scapular Dyskinesis
It is measured with visual observation at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement
Time frame: Change from baseline to 12 weeks
Scapular Dyskinesis
It is measured with visual observation at rest and during movement (loaded and unloaded, in abduction and in flexion); the presence of winging, tilting or abnormal scapular movement determines the judgement about scapular dyskinesis (yes/no) at rest and during movement
Time frame: Change from baseline to 6 months
Scapular Correction
it is measured with the reduction of symptoms during 2 tests: 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.
Time frame: Change from baseline to 12 weeks
Scapular Correction
it is measured with the reduction of symptoms during 2 tests: 2) the scapular assistance test (SAT); if the pain reduces after the SAT, the test is considered positive; 3) scapular retraction test (SRT); if the pain reduces after the SRT, the test is considered positive.
Time frame: Change from baseline to 6 months
Acromiohumeral Distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Time frame: Change from baseline to 12 weeks
Acromiohumeral Distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Time frame: Change from baseline to 6 months
Coracohumeral distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Time frame: Change from baseline to 12 weeks
Coracohumeral distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Time frame: Change from baseline to 6 months
Supraspinatus Tendon Thickness
it is measured with the Ultrasound in Crass position (in millimeters)
Time frame: Change from baseline to 12 weeks
Supraspinatus Tendon Thickness
it is measured with the Ultrasound in Crass position (in millimeters)
Time frame: Change from baseline to 6 months
Subscapularis Tendon Thickness
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Time frame: Change from baseline to 12 weeks
Subscapularis Tendon Thickness
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Time frame: Change from baseline to 6 months