Subacromial Impingement SyndromeNCT04915430
Training in Subacromial Impingement Syndrome
A study testing Training in people with Subacromial Impingement Syndrome, run by Reumatologiklinikken.
Trial summary
A randomized controlled trial comparing a comprehensive supervised training regimen with a validated home-based regimen for subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacromial impingement syndrome
Who cannot join
- Ongoing claim with the Labour market insurance, insurance company or comparable institution.
- Ongoing application for job revalidation or health related pension.
- Radiating neck pain.
- Ultrasound verified complete rotator cuff tendon lesion, as defined by hypoechoic or anechoic full thickness defect of the tendon, or absence of the tendon.
- Periarthritis humeroscapularis.
- Acute luxation or fracture of the shoulder.
- Ongoing steady analgetic treatment of other concomitant painful condition, unrelated to the patients shoulder problem.
About this study
Official title: Comprehensive Supervised Heavy Training Program Versus Home Training Regimen in Patients With Subacromial Impingement Syndrome: a Randomized Trial.
A randomized controlled trial comparing a comprehensive supervised training regimen with a validated home-based regimen for subacromial impingement syndrome.
Read the detailed description
The purpose of the study is to compare a comprehensive supervised training regimen (STR) based on latest evidence including heavy slow resistance training with a validated home-based regimen (HTR). We hypothesized that the STR would be superior to the HTR.
Randomised control trial with blinded assessor. 126 consecutive patients with subacromial impingement syndrome were recruited and equally randomised to 12 weeks of either supervised training regimen (STR), or home-based training regimen (HTR). Primary outcomes were Constant Score (CS) and Shoulder Rating Questionnaire (SRQ) from baseline and 6 months after completed training. Results were analyzed according to intention-to treat principles.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Training
- Keywords
- shoulder, rotator cuff, exercise
- Medical subject headings
- Shoulder Impingement Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Supervised training regimen | Active comparator | This training regimen consisted of 3 phases: the 1st focused on restoring motion, the 2nd on strengthening of the rotator cuff muscles, and the 3rd on strengthening of the scapular muscles. Stretching completed every training session.
* Motion training consisted of 6 exercises.
* Postural training: shoulder shrugs and shoulder retraction exercises.
* Glenohumeral training: pendulum exercises, and active assisted flexion, abduction and external rotation.
* Strengthening of the rotator cuff: side lying external rotation, internal rotation and scaption.
* Strengthening of the scapular muscles: press-up, push-up with a plus, serratus anterior supine punch, standing rowing (low row), and seated rowing (high row).
* Training sessions ended with 4 stretches: anterior shoulder stretch, posterior shoulder stretch, inferior capsular stretch, sleepers stretch.
Exercises were performed 3 times a week, with progression after the 1st week, and thereafter every 2nd week. Receives: Other: Training |
| Home training regimen | Active comparator | The program consisted of the following:
* 1 motion exercise: upper trapezius relaxation
* 3 strengthening exercises: serratus anterior strengthening exercise, humeral external rotation with the arm at the side of the body, and humeral external rotation with a rubber band and the arm at 90 degrees abduction.
* 2 stretching exercises: posterior shoulder and pectoralis minor stretching, Exercises were performed daily, with weekly progression. Receives: Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder constant score
Functional assessment of the shoulder
Measured: 6 months after ended training
Shoulder Rating Questionnaire
Self-administered questionnaire
Measured: 6 months after ended training
Secondary outcomes (5)
Passive motion
Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
Measured: 6 months after ended training
Active motion
Shoulder flexion, measurement in degrees; Shoulder abduction, measurement in degrees; Shoulder internal rotation, measurement in degrees; Shoulder external rotation, measurement in degrees.
Measured: 6 months after ended training
Visual Analogue Scale
Measurement of pain on a 10 cm scale, where 0 indicates no pain, and 10 worst pain for the following muscle tests: full can test, empty can test, lift off test, resisted external rotation, palm-up test, Yergason´s test.
Measured: 6 months after ended training
Neer test
Stabilization of the patient's scapula with one hand, while passively flexing the arm while it is internally rotated. If the patient reports pain in this position, then the result of the test is considered to be positive (rated positive = 1 and negative = 0).
Measured: 6 months after ended training
Hawkins test
Placing the patient's shoulder in 90 degrees of shoulder flexion with the elbow flexed to 90 degrees, and afterwards internally rotating the arm. The test is considered to be positive if the patient experiences pain with internal rotation (rated positive = 1 and negative = 0).
Measured: 6 months after ended training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study startSep 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial 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
- Model description
- Patients were randomized to either a supervised training regimen (STR) or a home training regimen
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reumatologiklinikken
- Sponsor type
- University, hospital or other
- Collaborators
- Fonden for Faglig Udvikling af Speciallægepraksis
- Responsible party
- Sponsor
- Investigators
- Pierre Schydlowsky, MD, PhD, Principal investigator, Owner of the clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915430
- Sponsor's protocol ID
- PS_01
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schydlowsky P, Szkudlarek M, Madsen OR. Comprehensive supervised heavy training program versus home training regimen in patients with subacromial impingement syndrome: a randomized trial. BMC Musculoskelet Disord. 2022 Jan 15;23(1):52. doi: 10.1186/s12891-021-04969-0.
PubMed 35033043
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Supervised Heavy Training Program Versus Home Training Regimen in Patients With Subacromial Impingement Syndrome: a Randomized Trial.
- ClinicalTrials.gov ID
- NCT04915430
- Acronym / sponsor ID
- PS_01
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- shoulder, rotator cuff, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- ReumatologiklinikkenUniversity, hospital or other
- Collaborators
- Fonden for Faglig Udvikling af Speciallægepraksis
- Study start
- Sep 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 7 Jun 2021 (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.
A randomized controlled trial comparing a comprehensive supervised training regimen with a validated home-based regimen for subacromial impingement syndrome.
Detailed description
The purpose of the study is to compare a comprehensive supervised training regimen (STR) based on latest evidence including heavy slow resistance training with a validated home-based regimen (HTR). We hypothesized that the STR would be superior to the HTR.
Randomised control trial with blinded assessor. 126 consecutive patients with subacromial impingement syndrome were recruited and equally randomised to 12 weeks of either supervised training regimen (STR), or home-based training regimen (HTR). Primary outcomes were Constant Score (CS) and Shoulder Rating Questionnaire (SRQ) from baseline and 6 months after completed training. Results were analyzed according to intention-to treat principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients were randomized to either a supervised training regimen (STR) or a home training regimen
| Arm | Type | Receives |
|---|---|---|
| Supervised training regimen | Active comparator | Other: TrainingThis training regimen consisted of 3 phases: the 1st focused on restoring motion, the 2nd on strengthening of the rotator cuff muscles, and the 3rd on strengthening of the scapular muscles. Stretching completed every training session. * Motion training consisted of 6 exercises. * Postural training: shoulder shrugs and shoulder retraction exercises. * Glenohumeral training: pendulum exercises, and active assisted flexion, abduction and external rotation. * Strengthening of the rotator cuff: side lying external rotation, internal rotation and scaption. * Strengthening of the scapular muscles: press-up, push-up with a plus, serratus anterior supine punch, standing rowing (low row), and seated rowing (high row). * Training sessions ended with 4 stretches: anterior shoulder stretch, posterior shoulder stretch, inferior capsular stretch, sleepers stretch. Exercises were performed 3 times a week, with progression after the 1st week, and thereafter every 2nd week. |
| Home training regimen | Active comparator | Other: TrainingThe program consisted of the following: * 1 motion exercise: upper trapezius relaxation * 3 strengthening exercises: serratus anterior strengthening exercise, humeral external rotation with the arm at the side of the body, and humeral external rotation with a rubber band and the arm at 90 degrees abduction. * 2 stretching exercises: posterior shoulder and pectoralis minor stretching, Exercises were performed daily, with weekly progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subacromial impingement syndrome
Key exclusion criteria (7 listed)
- Ongoing claim with the Labour market insurance, insurance company or comparable institution.
- Ongoing application for job revalidation or health related pension.
- Radiating neck pain.
- Ultrasound verified complete rotator cuff tendon lesion, as defined by hypoechoic or anechoic full thickness defect of the tendon, or absence of the tendon.
- Periarthritis humeroscapularis.
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 |
|---|---|---|
| Training | Other | Home training regimen, Supervised training regimen |
Primary outcome
Shoulder constant score
Time frame: 6 months after ended training
Functional assessment of the shoulder
Shoulder Rating Questionnaire
Time frame: 6 months after ended training
Self-administered questionnaire
5 secondary outcomes
Passive motion
Time frame: 6 months after ended training
Active motion
Time frame: 6 months after ended training
Visual Analogue Scale
Time frame: 6 months after ended training
Neer test
Time frame: 6 months after ended training
Hawkins test
Time frame: 6 months after ended training
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 7 Jun 2021.
- Derived from this study: PubMed 35033043Schydlowsky P, Szkudlarek M, Madsen OR. Comprehensive supervised heavy training program versus home training regimen in patients with subacromial impingement syndrome: a randomized trial. BMC Musculoskelet Disord. 2022 Jan 15;23(1):52. doi: 10.1186/s12891-021-04969-0.
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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.
Pierre Schydlowsky, MD, PhD principal investigator
Owner of the clinics
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Subacromial Impingement Syndrome, run by Reumatologiklinikken.
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 1 inclusion and 7 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 constant score (time frame: 6 months after ended training). The study lists 2 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 NCT04915430, 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 7 Jun 2021.