Subacromial Impingement SyndromeSAISNCT05266391
Injection Technique in Subacromial Impingement Syndrome
An observational study of Subacromial Impingement Syndrome, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- subacromial corticosteroid injections
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Sep 2018
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the diagnosis of Subacromial impingement syndrome who underwent subacromial corticosteroid injections in our interventional physiatry clinic between September 2017 and February 2018 were included in this study.
Who may be able to join
- Shoulder posterolateral pain that increased with shoulder abduction,
- Restriction of the shoulder passive and active range of motion (ROM),
- Patients with positive Neer and Hawkins impingement test,
- Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
- Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).
Who cannot join
- Patients who received corticosteroid, local anesthetic, hyaluronic acid, and platelet-rich plasma injections in the shoulder in the last one year,
- patients who had previous history of surgery or fracture in their thorax, neck, upper extremity or shoulder joint,
- patients with a rheumatological, cognitive or psychiatric, central or peripheral neurological disease (stroke, spinal cord injury, brachial plexus injury, etc.),
- patients whose MRI presented a partial or complete rotator cuff tear, calcific tendinitis or labral tear.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: Comparison of Clinical Results of Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections in Subacromial Impingement Syndrome
Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. It is very important to control the pain in order to reduce the loss to the labor force and prevent the pain from becoming chronic. Various physical treatment methods such as ultrasound, hot pack, transcutaneous electrical nerve stimulation, etc., and injections or medical agents are recommended. This study aimed to compare the effects of ultrasound (US)-guided in comparison to landmark guided subacromial corticosteroids injection on shoulder range of motion (ROM), pain, and functional status in patients with subacromial impingement syndrome (SAIS).
Read the detailed description
Patients were assigned to two groups: Group-1 included patients who received US-guided subacromial corticosteroid injections; Group-2 included patients who underwent blind subacromial corticosteroid injections. The primary Outcome Measure was a Visual analog scale. Secondary Outcome Measures were Shoulder joint range of motion (ROM), Shoulder Pain and Disability Index (SPADI), The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH).
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- subacromial corticosteroid injections
- 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.
subacromial corticosteroid injectionsOther
Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patients who received US-guided subacromial corticosteroid injections Receives: Other: subacromial corticosteroid injections | |
| group 2 | patients who underwent blind subacromial corticosteroid injections Receives: Other: subacromial corticosteroid injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
It is a scale scored from 0 to 10 to evaluate the severity of pain. Patients are asked to rate the pain they feel as '0' for no pain and '10' for the most severe pain they have encountered in their life
Measured: Change from baseline visual analogue scale score at 1 month
Secondary outcomes (3)
Shoulder joint range of motion (ROM)
Shoulder ROMs were evaluated using a goniometer according to the standard method. Those with shoulder flexion lower than 160° and external rotation lower than 90° were recorded as restricted ROM
Measured: Change from baseline Shoulder joint range of motion at 1 month
Shoulder Pain and Disability Index (SPADI)
It is a scale in which pain and the limitation of shoulder function are evaluated between 0 and 10 points. Five items for the pain is scored 0 for "no pain," and 10 points for "most severe pain." Eight items for disability is scored 0 for "no difficulty," and 10 points for "difficulty requiring assistance." SPADI is a useful scale in both clinical practice and clinical trials, as it can also detect changes in the status of patients
Measured: Change from baseline Shoulder Pain and Disability Index at 1 month
The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)
It is used to evaluate the difficulty in performing various physical activities due to disabilities of the shoulder, arm or hand (6 items), the severity of pain and tingling (2 items), and the effect of the disability on social activities, work, and sleep (3 items). It is the shortened version of the DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) in 11 items. Each item is scored between 1 and 5. "No difficulty" is scored as 1 and "unable" is scored as 5 points. At least 10 of the 11 items must be answered. The final score is calculated from zero (no disability) to 100 (severe disability). Two optional items of the Quick DASH (work, and sports or music) were not used in this study.
Measured: Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Jun 2018
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kadriye Ones, Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266391
- Sponsor's protocol ID
- PMRTURKEY
- Acronym
- SAIS
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: results and conclusions
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Results of Ultrasound-Guided Versus Blind Subacromial Corticosteroid Injections in Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05266391
- Acronym / sponsor ID
- SAIS / PMRTURKEY
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 4 Mar 2022 (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.
Since pain is usually accompanied by a substantial effect on daily life that results in the extensive use of healthcare resources. In subacromial impingement syndrome, shoulder pain affects the quality of life negatively by affecting upper extremity functions and interrupting night sleep. It is very important to control the pain in order to reduce the loss to the labor force and prevent the pain from becoming chronic. Various physical treatment methods such as ultrasound, hot pack, transcutaneous electrical nerve stimulation, etc., and injections or medical agents are recommended. This study aimed to compare the effects of ultrasound (US)-guided in comparison to landmark guided subacromial corticosteroids injection on shoulder range of motion (ROM), pain, and functional status in patients with subacromial impingement syndrome (SAIS).
Detailed description
Patients were assigned to two groups: Group-1 included patients who received US-guided subacromial corticosteroid injections; Group-2 included patients who underwent blind subacromial corticosteroid injections. The primary Outcome Measure was a Visual analog scale. Secondary Outcome Measures were Shoulder joint range of motion (ROM), Shoulder Pain and Disability Index (SPADI), The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: subacromial corticosteroid injectionspatients who received US-guided subacromial corticosteroid injections |
| group 2 | – | Other: subacromial corticosteroid injectionspatients who underwent blind subacromial corticosteroid injections |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of Subacromial impingement syndrome who underwent subacromial corticosteroid injections in our interventional physiatry clinic between September 2017 and February 2018 were included in this study.
Key inclusion criteria (5 listed)
- Shoulder posterolateral pain that increased with shoulder abduction,
- Restriction of the shoulder passive and active range of motion (ROM),
- Patients with positive Neer and Hawkins impingement test,
- Patients with SAIS whose diagnosis was confirmed by magnetic resonance imaging (MRI), and
- Patients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate).
Key exclusion criteria (4 listed)
- Patients who received corticosteroid, local anesthetic, hyaluronic acid, and platelet-rich plasma injections in the shoulder in the last one year,
- patients who had previous history of surgery or fracture in their thorax, neck, upper extremity or shoulder joint,
- patients with a rheumatological, cognitive or psychiatric, central or peripheral neurological disease (stroke, spinal cord injury, brachial plexus injury, etc.),
- patients whose MRI presented a partial or complete rotator cuff tear, calcific tendinitis or labral tear.
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 |
|---|---|---|
| subacromial corticosteroid injectionsPatients with SAIS whose application of corticosteroid in their injections were the same in terms of type and dose (1 ml betamethasone dipropionate + betamethasone sodium phosphate). | Other | group 1, group 2 |
Primary outcome
Visual analogue scale (VAS)
Time frame: Change from baseline visual analogue scale score at 1 month
It is a scale scored from 0 to 10 to evaluate the severity of pain. Patients are asked to rate the pain they feel as '0' for no pain and '10' for the most severe pain they have encountered in their life
3 secondary outcomes
Shoulder joint range of motion (ROM)
Time frame: Change from baseline Shoulder joint range of motion at 1 month
Shoulder Pain and Disability Index (SPADI)
Time frame: Change from baseline Shoulder Pain and Disability Index at 1 month
The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH)
Time frame: Change from baseline The Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire at 1 month
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 4 Mar 2022.
- Individual participant dataSharing planned: Undecided. results and conclusions
Related trials for Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed 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.
Kadriye Ones, Prof study chair
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subacromial Impingement Syndrome, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 5 inclusion and 4 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 4 Mar 2022. 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?
Visual analogue scale (VAS) (time frame: Change from baseline visual analogue scale score at 1 month). 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 4 Mar 2022.