Exercise Into Pain in Subacromial Shoulder Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Other: exercising into pain
* Other: exercising with no/slight pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: shoulder pain for at least 3 months, elicited in the anterolateral shoulder region at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test resting pain should be at 2/10 maximum on verbal numerical pain rating scale (NPRS) 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 previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression primary diagnosis of acromioclavicular pathology, shoulder instability a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia) more than 4h of training in sport overhead shoulder activities per week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercising into pain<br>The participants will train during 12 with 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, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. One exercise will be performed with pain ranging between 4 and 7 on a NPRS (Numeric Pain Rating Scale) and the rest of the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. At week 9, patients will continue to exercise with pain between 0 and 2 in all exercises. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session. | Other: exercising into pain<br>* 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<br>|
| Active Comparator: exercising with no/slight pain<br>The participants will train during 12 weeks with 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, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. All the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session. | Other: exercising with no/slight pain<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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) | 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) | 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) | 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) | Change from baseline to 6 months | 
| Supraspinatus Tendon Thickness | it is measured with the Ultrasound in Crass position (in millimeters) | Change from baseline to 12 weeks | 
| Supraspinatus Tendon Thickness | it is measured with the Ultrasound in Crass position (in millimeters) | Change from baseline to 6 months | 
| Subscapularis Tendon Thickness | it is measured with the Ultrasound in maximal external rotation (in millimeters) | Change from baseline to 12 weeks | 
| Subscapularis Tendon Thickness | it is measured with the Ultrasound in maximal external rotation (in millimeters) | Change from baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder pain, subacromial impingement syndrome, exercise therapy