- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302711
Evaluation of the Effectiveness of Pericapsular Nerve Group Block in Hemiplegic Shoulder Pain
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 adding an ultrasound-guided PENG block to conventional physical therapy in patients with post-stroke hemiplegic shoulder pain, focusing on pain intensity, range of motion, and quality of life outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Savas Sencan, Assoc Prof
- Phone Number: +90 05370665713
- Email: savas-44@hotmail.com
Study Contact Backup
- Name: Ozlem M Eksi, MD
- Phone Number: +90 05425517553
- Email: ozlemeksi91@hotmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34722
- Marmara University
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Contact:
- Ozlem M Eksi, MD
- Phone Number: +90 05425517553
- Email: ozlemeksi91@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 85 years
Stroke onset less than 1 year
Presence of hemiplegic shoulder pain with limited shoulder range of motion confirmed by clinical examination
Numeric Rating Scale (NRS) pain score ≥ 4
Exclusion Criteria:
- Severe deformity or pathology of the shoulder region
Complex regional pain syndrome type I
Modified Ashworth Scale score ≥ 3
Presence of neglect syndrome
Grade 4 glenohumeral joint degeneration
Coagulopathy or bleeding disorders
Fracture on the affected side
Secondary pathology on MRI (malignancy or infection)
Presence of pacemaker
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
All participants will receive a single ultrasound-guided Pericapsular/Periarticular Nerve Group (PENG) block
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Pain Intensity (Numeric Rating Scale, NRS):
Time Frame: Baseline, 1 hour, 2 weeks, and 2 months post-intervention. Numeric Rating Scale
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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
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Baseline, 1 hour, 2 weeks, and 2 months post-intervention. Numeric Rating Scale
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time Frame: Baseline, 2 weeks, and 2 months
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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.
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Baseline, 2 weeks, and 2 months
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Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnaire
Time Frame: Baseline, 2 weeks, and 2 months
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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.
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Baseline, 2 weeks, and 2 months
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Modified Ashworth Scale (MAS)
Time Frame: Baseline, 2 weeks, and 2 months
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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.
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Baseline, 2 weeks, and 2 months
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Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: Baseline, 2 weeks, and 2 months
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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.
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Baseline, 2 weeks, and 2 months
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Modified Barthel Index (MBI)
Time Frame: Baseline, 2 weeks, and 2 months
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The MBI assesses activities of daily living (ADL) and functional independence.
Scores range from 0 to 100, with higher scores indicating greater independence.
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Baseline, 2 weeks, and 2 months
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Shoulder Range of Motion (ROM)
Time Frame: Baseline, 2 weeks, and 2 months
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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.
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Baseline, 2 weeks, and 2 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Joint Diseases
- Arthralgia
- Paralysis
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Shoulder Pain
- Hemiplegia
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Occlusion
Other Study ID Numbers
- 09.2025.25-0859
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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