HemiplegiaPhase 4NCT05260125
Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients
A Phase 4 study testing Ultrasound-guided Suprascapular Nerve Block and Anatomical Landmark-guided Suprascapular Nerve Block in people with Hemiplegia and Stroke, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Ultrasound-guided Suprascapular Nerve Block and Anatomical Landmark-guided Suprascapular Nerve Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 30 Mar 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having hemiplegic shoulder pain for 3 months
- Visual analogue scale score > 3 during passive shoulder joint movement on the hemiplegic side
Who cannot join
- Mini mental test score <24
- Patients with uncontrolled diabetes, coagulopathy
- Botulinum toxin administration in the past six months,
- Any injection in the shoulder region in the last six months
- Having hypersensitivity to injection agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abant Izzet Baysal University
Bolu, 14100
Serdar Kılınç, 905055913181, drserdarkilinc@hotmail.com
About this study
Official title: Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.
The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications.
Read the detailed description
Hemiplegic shoulder pain is a general term used to describe shoulder pain that occurs after a stroke. It is one of the complications that significantly affects the rehabilitation of patients.The suprascapular nerve takes up 70% of the sensation of the shoulder joint. For this reason, suprascapular nerve block treatment is applied in the treatment of hemiplegic shoulder pain.In patients with hemiplegic shoulder pain, suprascapular nerve block therapy can be performed under ultrasound guidance or using anatomical landmarks. However, there is no study in the literature comparing the effectiveness of ultrasound-guided and unguided suprascapular nerve block in the treatment of hemiplegic shoulder pain Patients with hemiplegic shoulder pain among the patients who received routine conservative rehabilitation treatment in the physical therapy and rehabilitation clinic with the diagnosis of post-stroke hemiplegia will be included in the study.
Hemiplegic patients aged 25-75 years, with shoulder pain lasting for 3 months and with a Visual Analogue Scale (VAS) value > 3 during passive shoulder joint movement will be included in the study.
Exclusion criteria from the study will be determined as mini mental test score < 24, uncontrolled diabetes, coagulopathy, botulinum toxin administration in the last six months, any injection from the shoulder region in the last six months, and hypersensitivity to injection agents.
It will be organized as a prospective randomized study. It is planned to include 50 patients in the study. Patients will be randomized into two groups in equal numbers, stratified by age and sex.
Patients in group 1 will be applied with ultrasound-guided suprascapular nerve block.
Patients in Group 2 will be applied with suprascapular nerve block using defined anatomical points without ultrasound guidance.
Initially, demographic data, medical history, stroke etiology, duration of stroke, body mass index, hemiplegic side information of the patients will be obtained.
Patients in both groups will be evaluated in terms of shoulder joint range of motion, Visual Analogue Scale, Brunnstrom Stages of Stroke Recovery, Barthel Index, Modified Ashworth Scale, The Beck Depression Inventory before the treatment, at the 1st week, 1st month and 3rd month after the injection.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Ultrasound-guided Suprascapular Nerve Block, Anatomical Landmark-guided Suprascapular Nerve Block
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Suprascapular Nerve BlockDrug
For suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used.
Injections will be applied to patients in a sitting position and arm by the side. A linear probe with a frequency of 7-8 MHz on the SonoScape A8 ultrasound device will be used for suprascapular block under ultrasound guidance. the ultrasound probe was placed in the coronal plane over the suprascapular fossa. Suprascapular fossa was scanned from medial to lateral side to identify suprascapular nerve. After identification, solution of suprascapular nerve block will be injected into the area around the nerve under the scanning with in-plane technique with a 22 gauge 90 mm spinal needle.
Anatomical Landmark-guided Suprascapular Nerve BlockDrug
For suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used.
Injections will be applied to patients in a sitting position and arm by the side. The suprascapular notch projection will be determined using the anatomical landmark technique defined by Dangoisse et al., and then suprascapular nerve block will be applied with a 22 gauge 90 mm spinal needle to the patients
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided Suprascapular Nerve Block | Experimental | Ultrasound-guided Suprascapular Nerve Block Receives: Drug: Ultrasound-guided Suprascapular Nerve Block |
| Anatomical Landmark-guided Suprascapular Nerve Block | Active comparator | Anatomical Landmark-guided Suprascapular Nerve Block Receives: Drug: Anatomical Landmark-guided Suprascapular Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Range of Motion
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Measured: Before suprascapular nerve block
Shoulder Range of Motion
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Measured: 1 week after suprascapular nerve block
Shoulder Range of Motion
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Measured: 4 week after suprascapular nerve block
Shoulder Range of Motion
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Measured: 12 week after suprascapular nerve block
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Measured: Before suprascapular nerve block
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Measured: 1 week after suprascapular nerve block
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Measured: 4 week after suprascapular nerve block
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Measured: 12 week after suprascapular nerve block
Secondary outcomes (16)
Barthel Index
The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.
Measured: Before suprascapular nerve block
Barthel Index
The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.
Measured: 1 week after suprascapular nerve block
Barthel Index
The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.
Measured: 4 week after suprascapular nerve block
Barthel Index
The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.
Measured: 12 week after suprascapular nerve block
Modified Ashworth Scale
Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.
Measured: Before suprascapular nerve block
Modified Ashworth Scale
Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.
Measured: 1 week after suprascapular nerve block
Modified Ashworth Scale
Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.
Measured: 4 week after suprascapular nerve block
Modified Ashworth Scale
Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.
Measured: 12 week after suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Measured: Before suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Measured: 1 week after suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Measured: 4 week after suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Measured: 12 week after suprascapular nerve block
The Beck Depression Inventory
The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.
Measured: Before suprascapular nerve block
The Beck Depression Inventory
The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.
Measured: 1 week after suprascapular nerve block
The Beck Depression Inventory
The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.
Measured: 4 week after suprascapular nerve block
The Beck Depression Inventory
The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.
Measured: 12 week after suprascapular nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Mar 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
- Investigators
- Serdar kılınç, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260125
- Sponsor's protocol ID
- AIBU-FTR-SK-01
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.
- ClinicalTrials.gov ID
- NCT05260125
- Acronym / sponsor ID
- AIBU-FTR-SK-01
- Conditions
- Hemiplegia, Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 2 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.
The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications.
Detailed description
Hemiplegic shoulder pain is a general term used to describe shoulder pain that occurs after a stroke. It is one of the complications that significantly affects the rehabilitation of patients.The suprascapular nerve takes up 70% of the sensation of the shoulder joint. For this reason, suprascapular nerve block treatment is applied in the treatment of hemiplegic shoulder pain.In patients with hemiplegic shoulder pain, suprascapular nerve block therapy can be performed under ultrasound guidance or using anatomical landmarks. However, there is no study in the literature comparing the effectiveness of ultrasound-guided and unguided suprascapular nerve block in the treatment of hemiplegic shoulder pain Patients with hemiplegic shoulder pain among the patients who received routine conservative rehabilitation treatment in the physical therapy and rehabilitation clinic with the diagnosis of post-stroke hemiplegia will be included in the study.
Hemiplegic patients aged 25-75 years, with shoulder pain lasting for 3 months and with a Visual Analogue Scale (VAS) value > 3 during passive shoulder joint movement will be included in the study.
Exclusion criteria from the study will be determined as mini mental test score < 24, uncontrolled diabetes, coagulopathy, botulinum toxin administration in the last six months, any injection from the shoulder region in the last six months, and hypersensitivity to injection agents.
It will be organized as a prospective randomized study. It is planned to include 50 patients in the study. Patients will be randomized into two groups in equal numbers, stratified by age and sex.
Patients in group 1 will be applied with ultrasound-guided suprascapular nerve block.
Patients in Group 2 will be applied with suprascapular nerve block using defined anatomical points without ultrasound guidance.
Initially, demographic data, medical history, stroke etiology, duration of stroke, body mass index, hemiplegic side information of the patients will be obtained.
Patients in both groups will be evaluated in terms of shoulder joint range of motion, Visual Analogue Scale, Brunnstrom Stages of Stroke Recovery, Barthel Index, Modified Ashworth Scale, The Beck Depression Inventory before the treatment, at the 1st week, 1st month and 3rd month after the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided Suprascapular Nerve Block | Experimental | Drug: Ultrasound-guided Suprascapular Nerve BlockUltrasound-guided Suprascapular Nerve Block |
| Anatomical Landmark-guided Suprascapular Nerve Block | Active comparator | Drug: Anatomical Landmark-guided Suprascapular Nerve BlockAnatomical Landmark-guided Suprascapular Nerve Block |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having hemiplegic shoulder pain for 3 months
- Visual analogue scale score > 3 during passive shoulder joint movement on the hemiplegic side
Key exclusion criteria (5 listed)
- Mini mental test score <24
- Patients with uncontrolled diabetes, coagulopathy
- Botulinum toxin administration in the past six months,
- Any injection in the shoulder region in the last six months
- Having hypersensitivity to injection agents
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 |
|---|---|---|
| Ultrasound-guided Suprascapular Nerve BlockFor suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used. Injections will be applied to patients in a sitting position and arm by the side. A linear probe with a frequency of 7-8 MHz on the SonoScape A8 ultrasound device will be used for suprascapular block under ultrasound guidance. the ultrasound probe was placed in the coronal plane over the suprascapular fossa. Suprascapular fossa was scanned from medial to lateral side to identify suprascapular nerve. After identification, solution of suprascapular nerve block will be injected into the area around the nerve under the scanning with in-plane technique with a 22 gauge 90 mm spinal needle. | Drug | Ultrasound-guided Suprascapular Nerve Block |
| Anatomical Landmark-guided Suprascapular Nerve BlockFor suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used. Injections will be applied to patients in a sitting position and arm by the side. The suprascapular notch projection will be determined using the anatomical landmark technique defined by Dangoisse et al., and then suprascapular nerve block will be applied with a 22 gauge 90 mm spinal needle to the patients | Drug | Anatomical Landmark-guided Suprascapular Nerve Block |
Primary outcome
Shoulder Range of Motion
Time frame: Before suprascapular nerve block
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Shoulder Range of Motion
Time frame: 1 week after suprascapular nerve block
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Shoulder Range of Motion
Time frame: 4 week after suprascapular nerve block
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Shoulder Range of Motion
Time frame: 12 week after suprascapular nerve block
The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.
Visual Analogue Scale
Time frame: Before suprascapular nerve block
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Visual Analogue Scale
Time frame: 1 week after suprascapular nerve block
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Visual Analogue Scale
Time frame: 4 week after suprascapular nerve block
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Visual Analogue Scale
Time frame: 12 week after suprascapular nerve block
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
16 secondary outcomes
Barthel Index
Time frame: Before suprascapular nerve block
Barthel Index
Time frame: 1 week after suprascapular nerve block
Barthel Index
Time frame: 4 week after suprascapular nerve block
Barthel Index
Time frame: 12 week after suprascapular nerve block
Modified Ashworth Scale
Time frame: Before suprascapular nerve block
Modified Ashworth Scale
Time frame: 1 week after suprascapular nerve block
Modified Ashworth Scale
Time frame: 4 week after suprascapular nerve block
Modified Ashworth Scale
Time frame: 12 week after suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Time frame: Before suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Time frame: 1 week after suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Time frame: 4 week after suprascapular nerve block
Brunnstrom Stages of Stroke Recovery
Time frame: 12 week after suprascapular nerve block
The Beck Depression Inventory
Time frame: Before suprascapular nerve block
The Beck Depression Inventory
Time frame: 1 week after suprascapular nerve block
The Beck Depression Inventory
Time frame: 4 week after suprascapular nerve block
The Beck Depression Inventory
Time frame: 12 week after suprascapular nerve block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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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.
Serdar kılınç principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-guided Suprascapular Nerve Block and Anatomical Landmark-guided Suprascapular Nerve Block in people with Hemiplegia and Stroke, run by Abant Izzet Baysal 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serdar Kılınç (9050559113181, drserdarkilinc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Range of Motion (time frame: Before suprascapular nerve block). The study lists 8 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 27 Feb 2025.