Subacromial Impingement SyndromeNCT06531889
Core Stabilization Exercises on Shoulder Impingement Syndrome
A study testing classical physiotherapy program and Core Stabilization Exercises in people with Subacromial Impingement Syndrome, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- classical physiotherapy program and Core Stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 30 Aug 2019
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 35 and 60 who were diagnosed by a Physical Therapy and Rehabilitation doctor with at least ten years of experience, whose SIS was confirmed by MRI, and who had shoulder complaints for at least three months, patients with positive signs, a positive Hawkins-Kennedy test, significant loss of active and passive shoulder movements or painful range of motion (ROM), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study
Who cannot join
- Patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Core Stabilization Exercises in Shoulder Impingement Syndrome: A Preliminary Retrospective Study
The objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- classical physiotherapy program, Core Stabilization Exercises
- 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.
classical physiotherapy programOther
Classical physiotherapy program=Classical physiotherapy program included transcutaneous electrical nerve stimulation, infrared radiation for 15 min, continuous ultrasound for 5 min and home exercise program. For active assistive shoulder range of motion (ROM), home exercises included the Codman exercise, flexion exercise at the ladder, and the Wand exercise, as well as some strengthening and stretching exercises performed at the pain limit with 10 repetitions twice a day (six weeks)
Core Stabilization ExercisesOther
The interventions of the core exercise were applied when the patient lay on his/her back with his/her knees at flexion. The number of repeats for each exercise was five, and these exercises were done 3 times a week for 6 weeks with the same physiotherapist. The further steps in the exercises were extended according to the activation duration of the core muscles, and this extension was elongated 5 s
| Study group | Role | What they receive |
|---|---|---|
| classical physiotherapy program | Active comparator | The group in classical physiotherapy program; n=25 (3 days per week for six weeks) Receives: Other: classical physiotherapy program |
| core stabilization group | Experimental | The group in which core stabilization was also performed in addition to classical physiotherapy program; n=25 (3 days per week for 6 weeks) Receives: Other: classical physiotherapy program; Other: Core Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NPRS-11)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: Change from baseline pain score at 6th week
New York Posture Rating Method to determine their postures
The rating chart is used to assess 13 areas of the body, based on the assumption that posture is the alignment of the body and its segments. 13 regions (head, neck, shoulder, scapula, upper thoracic, waist, rips, abdomen, hips, knees, legs, feet and toes) are assessed in two different positions (lateral and posterior). A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. higher the points better the postural alignment
Measured: Change from baseline pain score at 6th week
Shoulder pain and disability index
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
Measured: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
Secondary outcomes (4)
Shoulder mobility on the Shoulder Range of Motion
Shoulder ROM was measured in six directions (Flexion, Extension, Abduction, Adduction, Right rotation, Left rotation) with goniometer.
Measured: Change from baseline range of motion at 6th week
Core muscle strength test
The level of difficulty was raised from stage 1 to stage 5. high values are indicative of positive progress
Measured: Change from baseline strenght score at 6th week
Endurance of Core Muscles
Each test was repeated three times, and the average of the measurements was used. The Biering-Sørensen test measures how many seconds the participant can keep the unsupported upper part of the body in a horizontal position.high values are indicative of positive progress
Measured: Change from baseline endurance score at 6th week
Manual muscle test
The lowest value is zero and the highest value is 5. high values are indicative of positive progress
Measured: Change from baseline manual muscle testing score at 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Mar 2019
- Primary completion1 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Yeditepe University
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
- Investigators
- Nuray ALACA, Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531889
- Sponsor's protocol ID
- 37068608-6100-15-1757
- Status last verified
- Jul 2024
- First submitted
- 15 Dec 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stabilization Exercises in Shoulder Impingement Syndrome: A Preliminary Retrospective Study
- ClinicalTrials.gov ID
- NCT06531889
- Acronym / sponsor ID
- 37068608-6100-15-1757
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Yeditepe University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 1 Aug 2024 (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 objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in SIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical physiotherapy program | Active comparator | Other: classical physiotherapy programThe group in classical physiotherapy program; n=25 (3 days per week for six weeks) |
| core stabilization group | Experimental | Other: classical physiotherapy program, Other: Core Stabilization ExercisesThe group in which core stabilization was also performed in addition to classical physiotherapy program; n=25 (3 days per week for 6 weeks) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between the ages of 35 and 60 who were diagnosed by a Physical Therapy and Rehabilitation doctor with at least ten years of experience, whose SIS was confirmed by MRI, and who had shoulder complaints for at least three months, patients with positive signs, a positive Hawkins-Kennedy test, significant loss of active and passive shoulder movements or painful range of motion (ROM), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study
Key exclusion criteria (1 listed)
- Patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded
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 |
|---|---|---|
| classical physiotherapy programClassical physiotherapy program=Classical physiotherapy program included transcutaneous electrical nerve stimulation, infrared radiation for 15 min, continuous ultrasound for 5 min and home exercise program. For active assistive shoulder range of motion (ROM), home exercises included the Codman exercise, flexion exercise at the ladder, and the Wand exercise, as well as some strengthening and stretching exercises performed at the pain limit with 10 repetitions twice a day (six weeks) | Other | classical physiotherapy program, core stabilization group |
| Core Stabilization ExercisesThe interventions of the core exercise were applied when the patient lay on his/her back with his/her knees at flexion. The number of repeats for each exercise was five, and these exercises were done 3 times a week for 6 weeks with the same physiotherapist. The further steps in the exercises were extended according to the activation duration of the core muscles, and this extension was elongated 5 s | Other | core stabilization group |
Primary outcome
The Numerical Rating Scale (NPRS-11)
Time frame: Change from baseline pain score at 6th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
New York Posture Rating Method to determine their postures
Time frame: Change from baseline pain score at 6th week
The rating chart is used to assess 13 areas of the body, based on the assumption that posture is the alignment of the body and its segments. 13 regions (head, neck, shoulder, scapula, upper thoracic, waist, rips, abdomen, hips, knees, legs, feet and toes) are assessed in two different positions (lateral and posterior). A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. higher the points better the postural alignment
Shoulder pain and disability index
Time frame: Change from baseline score of The Shoulder Pain and Disability Index at 6th week
The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability between 0 to 100, with a higher value indicating worse condition.
4 secondary outcomes
Shoulder mobility on the Shoulder Range of Motion
Time frame: Change from baseline range of motion at 6th week
Core muscle strength test
Time frame: Change from baseline strenght score at 6th week
Endurance of Core Muscles
Time frame: Change from baseline endurance score at 6th week
Manual muscle test
Time frame: Change from baseline manual muscle testing score at 6th week
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 1 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Subacromial Impingement Syndrome
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
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.
Nuray ALACA study director
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classical physiotherapy program and Core Stabilization Exercises in people with Subacromial Impingement Syndrome, run by Acibadem University at 1 site in Turkey (Türkiye).
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 1 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 1 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 Turkey (Türkiye). 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?
The Numerical Rating Scale (NPRS-11) (time frame: Change from baseline pain score at 6th week). 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?
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 1 Aug 2024.