Shoulder PainNCT07302711
A New Approach to Hemiplegic Shoulder Pain; Pericapsular Nerve Group Block
An observational study of Shoulder Pain and Hemiplegia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Hemiplegic shoulder pain (HSP) is a common and clinically significant complication after stroke that negatively affects rehabilitation outcomes. It is associated with shoulder subluxation, capsular contracture, spasticity, and central pain mechanisms, leading to pain, limited range of motion, and reduced quality of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Pain, Hemiplegia
- What is being tested?
- Ultrasound-Guided Pericapsular/Periarticular Nerve Group (PENG) Block
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 1 Jun 2026
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Patients aged 18 to 85 years with post-stroke hemiplegic shoulder pain and limited shoulder joint range of motion will be recruited from the Pain Medicine and Physical Therapy Departments of Marmara University Pendik Training and Research Hospital. All participants will have experienced a stroke within the past year and will present with a Numeric Rating Scale (NRS) pain score of 4 or higher at baseline.
Who may be able to join
- Age between 18 and 85 years
- Presence of hemiplegic shoulder pain with limited shoulder range of motion confirmed by clinical examination
- Numeric Rating Scale (NRS) pain score ≥ 4
Who cannot join
- Severe deformity or pathology of the shoulder region
- Complex regional pain syndrome type I
- Presence of neglect syndrome
- Grade 4 glenohumeral joint degeneration
- Coagulopathy or bleeding disorders
- Fracture on the affected side
Show all 11Show fewer
- Secondary pathology on MRI (malignancy or infection)
- History of allergic reaction to local anesthetic agents or dexamethasone
- Shoulder intervention or injection within the past 3 months
- Major psychiatric illness
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Hemiplegic shoulder pain (HSP) is a common and clinically significant complication after stroke that negatively affects rehabilitation outcomes. It is associated with shoulder subluxation, capsular contracture, spasticity, and central pain mechanisms, leading to pain, limited range of motion, and reduced quality of life. The suprascapular nerve (SSN) block has been shown to be effective for shoulder pain management; however, the glenohumeral joint (GHJ) receives innervation from multiple nerves including the axillary, subscapular, and lateral pectoral nerves. The recently described pericapsular/periarticular nerve group (PENG) block targets these articular branches and may provide analgesia with minimal motor impairment.
This study aims to evaluate the effects of ultrasound-guided PENG block in patients with post-stroke hemiplegic shoulder pain, focusing on pain intensity, range of motion, and quality of life outcomes.
Read the detailed description
Pericapsular/Periarticular Nerve Group (PENG) Block Procedure:
The procedure is performed with the patient in the supine position, the affected arm externally rotated and abducted approximately 45 degrees. A high-frequency linear ultrasound probe is placed longitudinally between the coracoid process and the humeral head. After identifying the humeral head, the subscapularis muscle tendon, and the overlying deltoid muscle, an in-plane approach is used to advance a 100-mm needle between the deltoid muscle and the subscapularis tendon under real-time ultrasound guidance.
After confirming the needle tip position, a total of 10 mL of 0.25% bupivacaine hydrochloride combined with 4 mg of dexamethasone is injected slowly, ensuring appropriate spread within the targeted pericapsular space. The goal of the block is to provide analgesia for the glenohumeral joint by targeting the articular branches of the axillary, subscapular, and lateral pectoral nerves with minimal motor impairment.
No major complications have been reported for this technique in the literature. However, minor complications such as local bleeding, infection, or transient vasovagal reactions may occur.
- Conditions
- Shoulder Pain, Hemiplegia
- Being tested
- Ultrasound-Guided Pericapsular/Periarticular Nerve Group (PENG) Block
- Keywords
- PENG block, shoulder joint pain, Hemiplegic shoulder
- Medical subject headings
- Shoulder Pain, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Pericapsular/Periarticular Nerve Group (PENG) BlockProcedure or surgery
Under real-time ultrasound guidance, a 100-mm needle is advanced in-plane between the deltoid muscle and the subscapularis tendon with the patient in the supine position and the affected arm externally rotated and abducted at approximately 45 degrees.
A total of 10 mL of 0.25% bupivacaine hydrochloride combined with 4 mg of dexamethasone is injected slowly into the pericapsular space to provide analgesia to the glenohumeral joint.
| Study group | Role | What they receive |
|---|---|---|
| 1 | All participants will receive a single ultrasound-guided Pericapsular/Periarticular Nerve Group (PENG) block Receives: Procedure: Ultrasound-Guided Pericapsular/Periarticular Nerve Group (PENG) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (Numeric Rating Scale, NRS):
NRS is a scale in which the patient gives points between "0" and "10" for the low back and leg pain felt by the patient, "0" = No pain, "10" = The most severe, unbearable pain
Measured: Baseline, 1 hour, 2 weeks, and 2 months post-intervention. Numeric Rating Scale
Secondary outcomes (5)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
The Fugl-Meyer Upper Extremity Scale is a validated assessment tool designed to evaluate motor recovery after stroke. It includes motor function of the upper limb, wrist, hand movements, coordination, and reflex activity. Each item is scored from 0 to 2 (0 = cannot perform, 1 = partial performance, 2 = normal performance), with a total possible score of 66 points.
Measured: Baseline, 2 weeks, and 2 months
Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnaire
The QuickDASH is an 11-item self-reported questionnaire measuring upper extremity function and symptoms. Scores range from 0 to 100, where higher scores indicate greater disability.
Measured: Baseline, 2 weeks, and 2 months
Modified Ashworth Scale (MAS)
The MAS is a clinical tool used to assess muscle tone and spasticity. Muscle tone is rated from 0 (no increase in tone) to 4 (rigid in flexion or extension). Higher scores indicate more severe spasticity.
Measured: Baseline, 2 weeks, and 2 months
Stroke-Specific Quality of Life Scale (SS-QOL)
The SS-QOL is a 49-item stroke-specific scale assessing 12 domains related to quality of life, including mobility, upper extremity function, mood, energy, social roles, language, and thinking. Each item is rated on a 5-point Likert scale; higher scores represent better quality of life.
Measured: Baseline, 2 weeks, and 2 months
Shoulder Range of Motion (ROM)
Active and passive shoulder joint range of motion (flexion, abduction, internal and external rotation) will be measured using a goniometer. The range will be recorded at the point of pain onset and maximum movement.
Measured: Baseline, 2 weeks, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302711
- Sponsor's protocol ID
- 09.2025.25-0859
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Approach to Hemiplegic Shoulder Pain; Pericapsular Nerve Group Block
- ClinicalTrials.gov ID
- NCT07302711
- Acronym / sponsor ID
- 09.2025.25-0859
- Conditions
- Shoulder Pain, Hemiplegia
- Keywords
- PENG block, shoulder joint pain, Hemiplegic shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Dec 2025 (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.
Hemiplegic shoulder pain (HSP) is a common and clinically significant complication after stroke that negatively affects rehabilitation outcomes. It is associated with shoulder subluxation, capsular contracture, spasticity, and central pain mechanisms, leading to pain, limited range of motion, and reduced quality of life. The suprascapular nerve (SSN) block has been shown to be effective for shoulder pain management; however, the glenohumeral joint (GHJ) receives innervation from multiple nerves including the axillary, subscapular, and lateral pectoral nerves. The recently described pericapsular/periarticular nerve group (PENG) block targets these articular branches and may provide analgesia with minimal motor impairment.
This study aims to evaluate the effects of ultrasound-guided PENG block in patients with post-stroke hemiplegic shoulder pain, focusing on pain intensity, range of motion, and quality of life outcomes.
Detailed description
Pericapsular/Periarticular Nerve Group (PENG) Block Procedure:
The procedure is performed with the patient in the supine position, the affected arm externally rotated and abducted approximately 45 degrees. A high-frequency linear ultrasound probe is placed longitudinally between the coracoid process and the humeral head. After identifying the humeral head, the subscapularis muscle tendon, and the overlying deltoid muscle, an in-plane approach is used to advance a 100-mm needle between the deltoid muscle and the subscapularis tendon under real-time ultrasound guidance.
After confirming the needle tip position, a total of 10 mL of 0.25% bupivacaine hydrochloride combined with 4 mg of dexamethasone is injected slowly, ensuring appropriate spread within the targeted pericapsular space. The goal of the block is to provide analgesia for the glenohumeral joint by targeting the articular branches of the axillary, subscapular, and lateral pectoral nerves with minimal motor impairment.
No major complications have been reported for this technique in the literature. However, minor complications such as local bleeding, infection, or transient vasovagal reactions may occur.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Ultrasound-Guided Pericapsular/Periarticular Nerve Group (PENG) BlockAll participants will receive a single ultrasound-guided Pericapsular/Periarticular Nerve Group (PENG) block |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 85 years with post-stroke hemiplegic shoulder pain and limited shoulder joint range of motion will be recruited from the Pain Medicine and Physical Therapy Departments of Marmara University Pendik Training and Research Hospital. All participants will have experienced a stroke within the past year and will present with a Numeric Rating Scale (NRS) pain score of 4 or higher at baseline.
Key inclusion criteria (3 listed)
- Age between 18 and 85 years
- Presence of hemiplegic shoulder pain with limited shoulder range of motion confirmed by clinical examination
- Numeric Rating Scale (NRS) pain score ≥ 4
Key exclusion criteria (11 listed)
- Severe deformity or pathology of the shoulder region
- Complex regional pain syndrome type I
- Presence of neglect syndrome
- Grade 4 glenohumeral joint degeneration
- Coagulopathy or bleeding disorders
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 Pericapsular/Periarticular Nerve Group (PENG) BlockUnder real-time ultrasound guidance, a 100-mm needle is advanced in-plane between the deltoid muscle and the subscapularis tendon with the patient in the supine position and the affected arm externally rotated and abducted at approximately 45 degrees. A total of 10 mL of 0.25% bupivacaine hydrochloride combined with 4 mg of dexamethasone is injected slowly into the pericapsular space to provide analgesia to the glenohumeral joint. | Procedure or surgery | 1 |
Primary outcome
Change in Pain Intensity (Numeric Rating Scale, NRS):
Time frame: Baseline, 1 hour, 2 weeks, and 2 months post-intervention. Numeric Rating Scale
NRS is a scale in which the patient gives points between "0" and "10" for the low back and leg pain felt by the patient, "0" = No pain, "10" = The most severe, unbearable pain
5 secondary outcomes
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline, 2 weeks, and 2 months
Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnaire
Time frame: Baseline, 2 weeks, and 2 months
Modified Ashworth Scale (MAS)
Time frame: Baseline, 2 weeks, and 2 months
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: Baseline, 2 weeks, and 2 months
Shoulder Range of Motion (ROM)
Time frame: Baseline, 2 weeks, and 2 months
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 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shoulder Pain and Hemiplegia, 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 11 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 29 Jul 2026. 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?
Change in Pain Intensity (Numeric Rating Scale, NRS): (time frame: Baseline, 1 hour, 2 weeks, and 2 months post-intervention. Numeric Rating Scale). 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 29 Jul 2026.