Marmara University
Istanbul, 34722, Turkey (Türkiye)
NCT Number: NCT07302711
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Observational
Istanbul, 34722, Turkey (Türkiye)
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
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.
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
Time frame: Baseline, 2 weeks, and 2 months
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.
Time frame: Baseline, 2 weeks, and 2 months
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.
Time frame: Baseline, 2 weeks, and 2 months
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.
Time frame: Baseline, 2 weeks, and 2 months
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.
Time frame: Baseline, 2 weeks, and 2 months
The MBI assesses activities of daily living (ADL) and functional independence. Scores range from 0 to 100, with higher scores indicating greater independence.
Time frame: Baseline, 2 weeks, and 2 months
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.
Contact information is provided by the study sponsor or research team.
Marmara University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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