Subacromial Impingement SyndromeNCT04186624
Effectiveness of Supervised Exercise Program in Subacromial Impingement Syndrome
A study testing Subacromial-subdeltoid bursa corticosteroid injection in people with Subacromial Impingement Syndrome, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It is the most common cause of shoulder pain, with an incidence of 44-65%. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Subacromial-subdeltoid bursa corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2019to 1 Aug 2020
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms lasting longer than 3 months
- Aged between 20-60 years
- The diagnosis is made by the clinician and detected by MRI
Who cannot join
- History of physical therapy or injection in the last 3 months
- Shoulder fracture history
- Presence of Type III (hooked) acromion
- Complete rupture of the rotator cuff muscles
- Presence of instability problem in shoulder
- History of shoulder surgery
Show all 10Show fewer
- History of inflammatory rheumatoid disease
- Uncontrolled diabetes mellitus
- Allergy to steroids or local anesthetics (drug hypersensitivity)
- Known contraindications for interventional procedures (infection at the injection site, coagulopathy, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: Effectiveness of Supervised Exercise Program After Subacromial- Subdeltoid Bursitis Injection in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It is the most common cause of shoulder pain, with an incidence of 44-65%. Restriction of the range of motion, along with the pain in the anterior region of the shoulder, is the main reason for disability and decreased quality of life in patients with SIS. Physical exercises to improve the range of motion, strengthening, and flexibility is the main part of treatment. The subacromial-subdeltoid bursa corticosteroid injection is shown to decrease pain during the exercise program and increase participation in the treatment. This study aims to compare the effectiveness of a supervised exercise program and home-based exercise program after subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.
Read the detailed description
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It was first described in 1972 by Neer. Neer described SIS as a progressive syndrome with three stages, beginning with chronic bursitis and proceeding to partial and complete tears of the supraspinatus tendon, which may extend to rupture of other parts of the rotator cuff and may also involve the long biceps tendon. SIS is one of the most common causes of shoulder pain and disability reasons in both primary and secondary care. It is characterized by functional impairment of shoulder resulted from the progressive limitation of both active and passive glenohumeral movements. Restriction of the range of motion (ROM) along with the pain in the anterior region of the shoulder that gets worse with arm elevation or overhead activities is the main reason for decreased quality of life in patients with SIS. Therapeutic exercise programs are commonly used treatment methods in relieving pain and improving ROM and muscle elasticity. It was shown that such programs are more effective in reducing pain and improving functional loss than placebo in both short- and long-term. However, the optimal exercise regimen with the variety, frequency, and intensity exercises is still unclear. It is also controversial if a supervised exercise program is superior to a prescribed home-based exercise program. An efficient exercise program should target all structures affected by subacromial impingement. Therefore, both supervised and home-based exercise programs must involve rotator cuff and scapular stabilizing muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. Corticosteroid injection into the subacromial-subdeltoid bursa is shown to increase participation, decrease pain during the exercise program, and found to be effective for symptomatic impingement. The analgesic effect provides significant improvement of functions mainly in the short-term. Therefore, some physicians prefer corticosteroid injections alone in the treatment of SIS. However, it was found that the combination of corticosteroid injection and exercise program is significantly superior to corticosteroid injections alone. Ultrasound-guided subacromial-subdeltoid bursa injections are shown to have better outcome results than blind injections for both pain and overall shoulder function. This study aims to compare the effectiveness of supervised exercise and home-based exercise programs after ultrasound-guided subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.
Patients diagnosed with SIS will be included and randomized into two groups. Both groups will receive subacromial-subdeltoid bursa 1 ml (7 mg/ml) betamethasone and 4 ml of 0.5% bupivacaine injection. The injection will be performed ultrasound-guided while the patient is in a sitting position with the lateral approach. The first group will perform their exercises under the supervision of the physiotherapist in the hospital. The second group will be taken to the home-based exercise program in a brochure format. Thus, both groups will receive the same exercises every day.
The pain will be assessed with the Visual Analogue Scale (VAS), active and passive ROM will be measured with a goniometer before injection, immediately, first hour, third week, and third month after the injection. The quality of life will be evaluated by Short Form 36, and disability will be questioned by Shoulder Pain and Disability Index before injection and third week and third month after injection.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Subacromial-subdeltoid bursa corticosteroid injection
- Keywords
- Subacromial Impingement Syndrome, Subacromial-subdeltoid bursa corticosteroid injection, Exercise Therapy
- 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-subdeltoid bursa corticosteroid injectionDrug
Also called Subacromial-subdeltoid bursa injection
1 ml (7 mg / ml) betamethasone and 4 ml of 0.5% bupivacaine will be given subacromial bursa-subdeltoid space. Injection will be performed ultrasound-guided while the patient is in sitting position with the lateral approach.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Program | Experimental | The exercise program that applied at the hospital includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. Receives: Drug: Subacromial-subdeltoid bursa corticosteroid injection |
| Home-based Exercise Program | Active comparator | The home-based exercise program given with a brochure that includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. Receives: Drug: Subacromial-subdeltoid bursa corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Measured: before treatment (T0)
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Measured: 1st hour after injection (T1)
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Measured: 3rd week of treatment (T2)
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Measured: 3rd month of treatment (T3)
Secondary outcomes (10)
Pain and Disability - SPADI
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Measured: before treatment (T0)
Pain and Disability - SPADI
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Measured: 3rd week of treatment (T1)
Pain and Disability - SPADI
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Measured: 3rd month of treatment (T2)
Quality of life- Short Form-36
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Measured: before treatment (T0)
Quality of life- Short Form-36
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Measured: 3rd week of treatment (T1)
Quality of life- Short Form-36
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Measured: 3rd month of treatment (T2)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Measured: before treatment (T0)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Measured: 1st hour after injection (T1)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Measured: 3rd week of treatment (T2)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Measured: 3rd month of treatment (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start5 Dec 2019
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Non-randomised
- Intervention model
- Single group
- Model description
- This randomized controlled study is designed to have two groups with a single arm.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen Gencer Atalay, Marmara University
- Investigators
- İlker Yağcı, Prof, Study chair, Marmara UniversityEbru Kaplan, PT, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186624
- Sponsor's protocol ID
- 09.2019.347
- Status last verified
- Feb 2020
- First submitted
- 25 Nov 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.
PubMed 31726927Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.
PubMed 26093810Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
PubMed 28630217Burger M, Africa C, Droomer K, Norman A, Pheiffe C, Gericke A, Samsodien A, Miszewski N. Effect of corticosteroid injections versus physiotherapy on pain, shoulder range of motion and shoulder function in patients with subacromial impingement syndrome: A systematic review and meta-analysis. S Afr J Physiother. 2016 Sep 27;72(1):318. doi: 10.4102/sajp.v72i1.318. eCollection 2016.
PubMed 30135893Kromer TO, de Bie RA, Bastiaenen CH. Effectiveness of physiotherapy and costs in patients with clinical signs of shoulder impingement syndrome: One-year follow-up of a randomized controlled trial. J Rehabil Med. 2014 Nov;46(10):1029-36. doi: 10.2340/16501977-1867.
PubMed 25211291
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supervised Exercise Program After Subacromial- Subdeltoid Bursitis Injection in Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT04186624
- Acronym / sponsor ID
- 09.2019.347
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Subacromial Impingement Syndrome, Subacromial-subdeltoid bursa corticosteroid injection, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 5 Dec 2019 (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.
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It is the most common cause of shoulder pain, with an incidence of 44-65%. Restriction of the range of motion, along with the pain in the anterior region of the shoulder, is the main reason for disability and decreased quality of life in patients with SIS. Physical exercises to improve the range of motion, strengthening, and flexibility is the main part of treatment. The subacromial-subdeltoid bursa corticosteroid injection is shown to decrease pain during the exercise program and increase participation in the treatment. This study aims to compare the effectiveness of a supervised exercise program and home-based exercise program after subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.
Detailed description
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It was first described in 1972 by Neer. Neer described SIS as a progressive syndrome with three stages, beginning with chronic bursitis and proceeding to partial and complete tears of the supraspinatus tendon, which may extend to rupture of other parts of the rotator cuff and may also involve the long biceps tendon. SIS is one of the most common causes of shoulder pain and disability reasons in both primary and secondary care. It is characterized by functional impairment of shoulder resulted from the progressive limitation of both active and passive glenohumeral movements. Restriction of the range of motion (ROM) along with the pain in the anterior region of the shoulder that gets worse with arm elevation or overhead activities is the main reason for decreased quality of life in patients with SIS. Therapeutic exercise programs are commonly used treatment methods in relieving pain and improving ROM and muscle elasticity. It was shown that such programs are more effective in reducing pain and improving functional loss than placebo in both short- and long-term. However, the optimal exercise regimen with the variety, frequency, and intensity exercises is still unclear. It is also controversial if a supervised exercise program is superior to a prescribed home-based exercise program. An efficient exercise program should target all structures affected by subacromial impingement. Therefore, both supervised and home-based exercise programs must involve rotator cuff and scapular stabilizing muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. Corticosteroid injection into the subacromial-subdeltoid bursa is shown to increase participation, decrease pain during the exercise program, and found to be effective for symptomatic impingement. The analgesic effect provides significant improvement of functions mainly in the short-term. Therefore, some physicians prefer corticosteroid injections alone in the treatment of SIS. However, it was found that the combination of corticosteroid injection and exercise program is significantly superior to corticosteroid injections alone. Ultrasound-guided subacromial-subdeltoid bursa injections are shown to have better outcome results than blind injections for both pain and overall shoulder function. This study aims to compare the effectiveness of supervised exercise and home-based exercise programs after ultrasound-guided subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.
Patients diagnosed with SIS will be included and randomized into two groups. Both groups will receive subacromial-subdeltoid bursa 1 ml (7 mg/ml) betamethasone and 4 ml of 0.5% bupivacaine injection. The injection will be performed ultrasound-guided while the patient is in a sitting position with the lateral approach. The first group will perform their exercises under the supervision of the physiotherapist in the hospital. The second group will be taken to the home-based exercise program in a brochure format. Thus, both groups will receive the same exercises every day.
The pain will be assessed with the Visual Analogue Scale (VAS), active and passive ROM will be measured with a goniometer before injection, immediately, first hour, third week, and third month after the injection. The quality of life will be evaluated by Short Form 36, and disability will be questioned by Shoulder Pain and Disability Index before injection and third week and third month after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This randomized controlled study is designed to have two groups with a single arm.
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Program | Experimental | Drug: Subacromial-subdeltoid bursa corticosteroid injectionThe exercise program that applied at the hospital includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. |
| Home-based Exercise Program | Active comparator | Drug: Subacromial-subdeltoid bursa corticosteroid injectionThe home-based exercise program given with a brochure that includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Symptoms lasting longer than 3 months
- Aged between 20-60 years
- The diagnosis is made by the clinician and detected by MRI
Key exclusion criteria (10 listed)
- History of physical therapy or injection in the last 3 months
- Shoulder fracture history
- Presence of Type III (hooked) acromion
- Complete rupture of the rotator cuff muscles
- Presence of instability problem in shoulder
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-subdeltoid bursa corticosteroid injectionAlso: Subacromial-subdeltoid bursa injection1 ml (7 mg / ml) betamethasone and 4 ml of 0.5% bupivacaine will be given subacromial bursa-subdeltoid space. Injection will be performed ultrasound-guided while the patient is in sitting position with the lateral approach. | Drug | Home-based Exercise Program, Supervised Exercise Program |
Primary outcome
Pain and tightness sensation
Time frame: before treatment (T0)
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Pain and tightness sensation
Time frame: 1st hour after injection (T1)
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Pain and tightness sensation
Time frame: 3rd week of treatment (T2)
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Pain and tightness sensation
Time frame: 3rd month of treatment (T3)
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
10 secondary outcomes
Pain and Disability - SPADI
Time frame: before treatment (T0)
Pain and Disability - SPADI
Time frame: 3rd week of treatment (T1)
Pain and Disability - SPADI
Time frame: 3rd month of treatment (T2)
Quality of life- Short Form-36
Time frame: before treatment (T0)
Quality of life- Short Form-36
Time frame: 3rd week of treatment (T1)
Quality of life- Short Form-36
Time frame: 3rd month of treatment (T2)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Time frame: before treatment (T0)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Time frame: 1st hour after injection (T1)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Time frame: 3rd week of treatment (T2)
Shoulder range of motion (ROM) will be evaluated with a goniometer
Time frame: 3rd month of treatment (T3)
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 3 Sep 2020.
- Background: PubMed 31726927Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.
- Background: PubMed 26093810Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.
- Background: PubMed 28630217Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
- Background: PubMed 30135893Burger M, Africa C, Droomer K, Norman A, Pheiffe C, Gericke A, Samsodien A, Miszewski N. Effect of corticosteroid injections versus physiotherapy on pain, shoulder range of motion and shoulder function in patients with subacromial impingement syndrome: A systematic review and meta-analysis. S Afr J Physiother. 2016 Sep 27;72(1):318. doi: 10.4102/sajp.v72i1.318. eCollection 2016.
- Background: PubMed 25211291Kromer TO, de Bie RA, Bastiaenen CH. Effectiveness of physiotherapy and costs in patients with clinical signs of shoulder impingement syndrome: One-year follow-up of a randomized controlled trial. J Rehabil Med. 2014 Nov;46(10):1029-36. doi: 10.2340/16501977-1867.
- Individual participant dataSharing planned: No
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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.
İlker Yağcı, Prof study chair
Marmara University
Ebru Kaplan, PT principal investigator
Marmara 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 Subacromial-subdeltoid bursa corticosteroid injection in people with Subacromial Impingement Syndrome, run by Marmara 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 3 inclusion and 10 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 3 Sep 2020. 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?
Pain and tightness sensation (time frame: before treatment (T0)). The study lists 4 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 NCT04186624, which also lists 5 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 3 Sep 2020.