Shoulder Impingement SyndromeNCT04154345

Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study

A study testing Exercise therapy (exercising into pain) in people with Shoulder Impingement Syndrome, run by Universiteit Antwerpen at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. 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?: Exercise therapy (exercising into pain)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteBelgium
Study dates: 28 Nov 2019to 14 May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

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 (50% or more than 30° loss of passive external rotation)
Previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Physiotherapy private practices
Antwerp

Other trials in Belgium

About this study

Read the 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.

Conditions: Shoulder Impingement Syndrome
Being tested: Exercise therapy (exercising into pain)
Medical subject headings: Shoulder Impingement Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exercise therapy (exercising into pain)Other
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.

Study groups in NCT04154345
Study group	Role	What they receive
Painful exercises	Experimental	The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Receives: Other: Exercise therapy (exercising into pain)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: measurement every session, final measure at the end of 12 weeks
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.
Measured: measurement every home exercise session, final measure at the end of 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.
Measured: value at baseline minus value at 12 weeks

Secondary outcomes (12)

Fear-Avoidance Beliefs Questionnaire (FABQ-PA)
Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs
Measured: value at baseline minus value at 12 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ-W)
Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs
Measured: value at baseline minus value at 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 indicate more fear and anxiety associated with pain.
Measured: value at baseline minus value at 12 weeks
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.
Measured: value at 12 weeks minus baseline
Passive ROM in Internal Rotation
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Measured: value at 12 weeks minus baseline
Passive ROM in Scaption
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Measured: value at 12 weeks minus baseline
Active ROM in External Rotation
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Measured: value at 12 weeks minus baseline
Active ROM in Internal Rotation
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Measured: value at 12 weeks minus baseline
Active ROM in Scaption
It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.
Measured: value at 12 weeks minus baseline
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.
Measured: value at 12 weeks minus value at baseline
MVC in Internal Rotation
It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.
Measured: values at 12 weeks minus values at baseline
MVC in Scaption
It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.
Measured: values at 12 weeks minus baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 201914 May 2020

First posted6 Nov 2019
Study start28 Nov 2019
Primary completion14 May 2020
Study completion14 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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: Not applicable
Intervention model: Single group
Model description: Prospective single-group study design
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04154345
Sponsor's protocol ID: 18/34/379
Status last verified: Jun 2025
First submitted: 25 Oct 2019
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cavaggion C, Juul-Kristensen B, Luque-Suarez A, Voogt L, Wollants G, O Conaire E, Struyf F. Exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study. BMJ Open. 2023 Oct 6;13(10):e070698. doi: 10.1136/bmjopen-2022-070698.
PubMed 37802620

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome

All Shoulder Impingement Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study
ClinicalTrials.gov ID: NCT04154345
Acronym / sponsor ID: 18/34/379
Conditions: Shoulder Impingement Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Universiteit AntwerpenUniversity, hospital or other
Collaborators: University of Malaga, Rotterdam University of Applied Sciences, University of Southern Denmark
Study start: 28 Nov 2019 (actual)
Primary completion: 14 May 2020 (actual)
Study completion: 14 May 2020 (actual)
First posted: 6 Nov 2019 (actual)
Results: Posted 24 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective single-group study design

Arm	Type	Receives
Painful exercises	Experimental	Other: Exercise therapy (exercising into pain)The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

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 (50% or more than 30° loss of passive external rotation)

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
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.	Other	Painful exercises

Primary outcome

Rate of Adherence (Physiotherapy Session)
Time frame: 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
Rate of Adherence (Adherence Home Exercises)
Time frame: 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.
Shoulder Pain and Disability Index (SPADI)
Time frame: 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.

12 secondary outcomes

Fear-Avoidance Beliefs Questionnaire (FABQ-PA)
Time frame: value at baseline minus value at 12 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ-W)
Time frame: value at baseline minus value at 12 weeks
Fear of Pain Questionnaire (FPQ-9)
Time frame: value at baseline minus value at 12 weeks
Passive Range of Motion (ROM) in External Rotation
Time frame: value at 12 weeks minus baseline
Passive ROM in Internal Rotation
Time frame: value at 12 weeks minus baseline
Passive ROM in Scaption
Time frame: value at 12 weeks minus baseline
Active ROM in External Rotation
Time frame: value at 12 weeks minus baseline
Active ROM in Internal Rotation
Time frame: value at 12 weeks minus baseline
Active ROM in Scaption
Time frame: value at 12 weeks minus baseline
Maximum Voluntary Contraction (MVC) in External Rotation
Time frame: value at 12 weeks minus value at baseline
MVC in Internal Rotation
Time frame: values at 12 weeks minus values at baseline
MVC in Scaption
Time frame: values at 12 weeks minus baseline

Results and safety

Results posted to the registry on 24 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Painful Exercises	12	8

Primary outcome: Rate of Adherence (Physiotherapy Session)

Time frame: measurement every session, final measure at the end of 12 weeks. Count of participants. Unit: Participants

Measure	Painful Exercises n = 8
Value	7

Primary outcome: Rate of Adherence (Adherence Home Exercises)

Time frame: measurement every home exercise session, final measure at the end of 12 weeks. Count of participants. Unit: Participants

Measure	Painful Exercises n = 8
Value	4

Primary outcome: Shoulder Pain and Disability Index (SPADI)

Time frame: value at baseline minus value at 12 weeks. Median (Full Range). Unit: score on a scale

Measure	Painful Exercises n = 8
Value	29.3 (13.8 to 75.9)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Painful Exercises	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Limitations of the feasibility study are specified in the published article

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37802620Cavaggion C, Juul-Kristensen B, Luque-Suarez A, Voogt L, Wollants G, O Conaire E, Struyf F. Exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study. BMJ Open. 2023 Oct 6;13(10):e070698. doi: 10.1136/bmjopen-2022-070698.
Individual participant dataSharing planned: No

Related trials for Shoulder Impingement Syndrome

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome

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 Exercise therapy (exercising into 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 6 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 24 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Adherence (Physiotherapy Session) (time frame: measurement every session, final measure at the end of 12 weeks). The study lists 3 primary outcomes in all. 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 NCT04154345, which also lists 1 linked publication.

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 24 Jun 2025.