Shoulder Impingement SyndromeNCT04553289
Exercise Into Pain in Subacromial Shoulder Pain
A study testing exercising into pain and exercising with no/slight pain in people with Shoulder Impingement Syndrome, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- exercising into pain and exercising with no/slight pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Aug 2020to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- exercising into pain, exercising with no/slight pain
- Keywords
- shoulder pain, subacromial impingement syndrome, exercise therapy
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercising into painOther
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
exercising with no/slight painOther
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)
| Study group | Role | What they receive |
|---|---|---|
| exercising into pain | Experimental | 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. Receives: Other: exercising into pain |
| exercising with no/slight pain | Active comparator | 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. Receives: Other: exercising with no/slight pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12 weeks
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline to 6 months
Supraspinatus Tendon Thickness
it is measured with the Ultrasound in Crass position (in millimeters)
Measured: Change from baseline to 12 weeks
Supraspinatus Tendon Thickness
it is measured with the Ultrasound in Crass position (in millimeters)
Measured: Change from baseline to 6 months
Subscapularis Tendon Thickness
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Measured: Change from baseline to 12 weeks
Subscapularis Tendon Thickness
it is measured with the Ultrasound in maximal external rotation (in millimeters)
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start30 Aug 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark
- Responsible party
- Principal investigator, Filip Struyf, Universiteit Antwerpen
- Investigators
- Filip Struyf, Professor, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553289
- Sponsor's protocol ID
- 18/34/379 (RCT)
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2020
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cavaggion C, Navarro-Ledesma S, Juul-Kristensen B, Luque-Suarez A, Voogt L, Struyf F. The effect of painful exercise on ultrasonographic outcomes in rotator cuff-related shoulder pain: Secondary analysis of a randomized controlled trial. J Back Musculoskelet Rehabil. 2025 Nov;38(6):1379-1388. doi: 10.1177/10538127251334430. Epub 2025 May 14.
PubMed 40368129Cavaggion C, Luque-Suarez A, Voogt L, Juul-Kristensen B, Wollants G, Beke L, Fransen E, Struyf F. Exercise into Pain in Chronic Rotator Cuff-Related Shoulder Pain: A Randomized Controlled Trial with 6-Month Follow-Up. Open Access J Sports Med. 2024 Nov 30;15:181-196. doi: 10.2147/OAJSM.S483272. eCollection 2024.
PubMed 39635498
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Into Pain in Subacromial Shoulder Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04553289
- Acronym / sponsor ID
- 18/34/379 (RCT)
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder pain, subacromial impingement syndrome, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercising into pain | Experimental | Other: exercising into painThe 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. |
| exercising with no/slight pain | Active comparator | Other: exercising with no/slight painThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercising into painthe 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 | Other | exercising into pain |
| exercising with no/slight painthe 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) | Other | exercising with no/slight pain |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Change from baseline to 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.
25 secondary outcomes
Shoulder Pain and Disability Index (SPADI)
Time frame: Change from baseline to 6 months
Visual Analogue Scale (VAS)
Time frame: Change from baseline to 12 weeks
Visual Analogue Scale (VAS)
Time frame: Change from baseline to 6 months
Health-Related Quality of Life
Time frame: Change from baseline to 12 weeks
Health-Related Quality of Life
Time frame: Change from baseline to 6 months
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Change from baseline to 12 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Change from baseline to 6 months
Fear of Pain Questionnaire (FPQ-9)
Time frame: Change from baseline to 12 weeks
Fear of Pain Questionnaire (FPQ-9)
Time frame: Change from baseline to 6 months
Range of Movement (ROM) in internal rotation, external rotation, scaption
Time frame: Change from baseline to 12 weeks
Range of Movement (ROM) in internal rotation, external rotation, scaption
Time frame: Change from baseline to 6 months
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Time frame: Change from baseline to 12 weeks
Maximum Voluntary Contraction (MVC) in internal rotation, external rotation, scaption
Time frame: Change from baseline to 6 months
Scapular Dyskinesis
Time frame: Change from baseline to 12 weeks
Scapular Dyskinesis
Time frame: Change from baseline to 6 months
Scapular Correction
Time frame: Change from baseline to 12 weeks
Scapular Correction
Time frame: Change from baseline to 6 months
Acromiohumeral Distance
Time frame: Change from baseline to 12 weeks
Acromiohumeral Distance
Time frame: Change from baseline to 6 months
Coracohumeral distance
Time frame: Change from baseline to 12 weeks
Coracohumeral distance
Time frame: Change from baseline to 6 months
Supraspinatus Tendon Thickness
Time frame: Change from baseline to 12 weeks
Supraspinatus Tendon Thickness
Time frame: Change from baseline to 6 months
Subscapularis Tendon Thickness
Time frame: Change from baseline to 12 weeks
Subscapularis Tendon Thickness
Time frame: Change from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 40368129Cavaggion C, Navarro-Ledesma S, Juul-Kristensen B, Luque-Suarez A, Voogt L, Struyf F. The effect of painful exercise on ultrasonographic outcomes in rotator cuff-related shoulder pain: Secondary analysis of a randomized controlled trial. J Back Musculoskelet Rehabil. 2025 Nov;38(6):1379-1388. doi: 10.1177/10538127251334430. Epub 2025 May 14.
- Derived from this study: PubMed 39635498Cavaggion C, Luque-Suarez A, Voogt L, Juul-Kristensen B, Wollants G, Beke L, Fransen E, Struyf F. Exercise into Pain in Chronic Rotator Cuff-Related Shoulder Pain: A Randomized Controlled Trial with 6-Month Follow-Up. Open Access J Sports Med. 2024 Nov 30;15:181-196. doi: 10.2147/OAJSM.S483272. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Struyf, Professor principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercising into pain and exercising with no/slight pain in people with Shoulder Impingement Syndrome, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04553289, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.