Back to resultsExercise Into Pain in Subacromial Shoulder Pain
Primary Purpose
Shoulder Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
exercising into pain
exercising with no/slight pain
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder pain, subacromial impingement syndrome, exercise therapy
Eligibility Criteria
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 VAS scale
Exclusion Criteria:
- 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)
- bilateral shoulder pain
- evidence of adhesive capsulitis
- history of shoulder surgery, fracture or dislocation (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, haemophilia, rheumatic polymyalgia)
- more than 4h of training in sport overhead shoulder activities per week
Sites / Locations
- Physiotherapy private practices
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
exercising into pain
exercising with no/slight pain
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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)
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)
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.
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.
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.
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.
Range of Movement (ROM) in internal rotation, external rotation, scaption
It is measured with the inclinometer. The unit of measure is degrees.
Range of Movement (ROM) in internal rotation, external rotation, scaption
It is measured with the inclinometer. The unit of measure is degrees.
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
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
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
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.
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.
Acromiohumeral Distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Acromiohumeral Distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Coracohumeral distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Coracohumeral distance
it is measured with the Ultrasound at 0 and 60 degrees of elevation in the scapular plane (in millimeters)
Supraspinatus Tendon Thickness
it is measured with the Ultrasound in Crass position (in millimeters)
Supraspinatus Tendon Thickness
it is measured with the Ultrasound in Crass position (in millimeters)
Subscapularis Tendon Thickness
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Subscapularis Tendon Thickness
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Full Information
NCT ID
NCT04553289
First Posted
August 20, 2020
Last Updated
May 9, 2023
Sponsor
Universiteit Antwerpen
Collaborators
University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04553289
Brief Title
Exercise Into Pain in Subacromial Shoulder Pain
Official Title
Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
shoulder pain, subacromial impingement syndrome, exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercising into pain
Arm Type
Experimental
Arm Description
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.
Arm Title
exercising with no/slight pain
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercising into pain
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
exercising with no/slight pain
Intervention Description
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)
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
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
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
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
Title
Visual Analogue Scale (VAS)
Description
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
Title
Visual Analogue Scale (VAS)
Description
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
Title
Health-Related Quality of Life
Description
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 12 weeks
Title
Health-Related Quality of Life
Description
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
Title
Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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
Title
Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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
Title
Fear of Pain Questionnaire (FPQ-9)
Description
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
Title
Fear of Pain Questionnaire (FPQ-9)
Description
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
Title
Range of Movement (ROM) in internal rotation, external rotation, scaption
Description
It is measured with the inclinometer. The unit of measure is degrees.
Time Frame
Change from baseline to 12 weeks
Title
Range of Movement (ROM) in internal rotation, external rotation, scaption
Description
It is measured with the inclinometer. The unit of measure is degrees.
Time Frame
Change from baseline to 6 months
Title
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Description
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Time Frame
Change from baseline to 12 weeks
Title
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Description
It is measured with the Hand-Held Dynamometer. The unit of measure is Newtons.
Time Frame
Change from baseline to 6 months
Title
Scapular Dyskinesis
Description
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
Title
Scapular Dyskinesis
Description
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
Title
Scapular Correction
Description
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
Title
Scapular Correction
Description
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
Title
Acromiohumeral Distance
Description
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
Title
Acromiohumeral Distance
Description
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
Title
Coracohumeral distance
Description
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
Title
Coracohumeral distance
Description
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
Title
Supraspinatus Tendon Thickness
Description
it is measured with the Ultrasound in Crass position (in millimeters)
Time Frame
Change from baseline to 12 weeks
Title
Supraspinatus Tendon Thickness
Description
it is measured with the Ultrasound in Crass position (in millimeters)
Time Frame
Change from baseline to 6 months
Title
Subscapularis Tendon Thickness
Description
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Time Frame
Change from baseline to 12 weeks
Title
Subscapularis Tendon Thickness
Description
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Time Frame
Change from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Global perceived effect (GPE)
Description
It is measured on a 7-Likert Scale, ranging from 1 (way much better) to 7 (way much worse); higher scores mean worst global perceived effect.
Time Frame
12 weeks
Title
Adherence
Description
It is analysed in terms of attendance to the physiotherapist-led sessions and adherence to the home-exercise protocol. Good level of adherence is defined by: attendance of 7/9 (80%) of physiotherapist led-sessions and 22/27 (80%) days of home-exercises completed.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip Struyf, Professor
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy private practices
City
Antwerp
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Exercise Into Pain in Subacromial Shoulder Pain
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