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Ultrasound-Guided PENG Block for Chronic Shoulder Pain

21. května 2026 aktualizováno: Ali ÇOŞTU, Ankara City Hospital Bilkent

Evaluation of the Analgesic Efficacy and Functional Outcomes of Ultrasound-Guided PENG Block in Chronic Shoulder Pain

The purpose of this prospective, observational study is to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients suffering from chronic shoulder pain. Chronic shoulder pain is a highly prevalent musculoskeletal problem that significantly restricts daily activities and diminishes the patient's quality of life. While conservative treatments and various interventional injections are widely used, long-term efficacy can be limited, and systemic side effects may occur. The shoulder PENG block is a novel regional analgesia technique that specifically targets the articular (sensory) branches of the nerves innervating the shoulder joint capsule without affecting the motor branches. In this single-center study, a total of 45 eligible adult patients with chronic shoulder pain who did not respond to conservative medical treatments will receive an ultrasound-guided PENG block as part of their routine clinical care. The procedure will be performed under sterile conditions using a combination of local anesthetic (lidocaine) and dexamethasone. Patient pain levels will be assessed using the Numerical Rating Scale (NRS), shoulder disability and functional status will be measured using the Shoulder Pain and Disability Index (SPADI), and overall patient satisfaction will be evaluated using the Global Perceived Effect (GPE) score. All parameters will be documented at baseline (before the procedure) and at follow-up visits on the 1st week, 4th week (1 month), and 3rd month post-procedure. The investigators aim to determine the efficacy, duration of effect, and safety profile of this intervention.

Přehled studie

Detailní popis

Study Design and Setting:

This is a prospective, observational, and single-center clinical study designed to evaluate the clinical and functional outcomes of ultrasound-guided Pericapsular Nerve Group (PENG) block in patients with chronic shoulder pain. The study will be conducted in accordance with the Declaration of Helsinki, and approval from the local clinical research ethics committee will be obtained prior to patient enrollment.

Patient Selection:

Adult patients (aged over 18 years) presenting with chronic shoulder pain lasting longer than 3 months, who have an initial Numerical Rating Scale (NRS) score greater than 4 and have not responded to conservative or medical treatments, will be screened for eligibility. Written informed consent will be obtained from all participating individuals. Patients with coagulation disorders, psychomotor disorders, active infections at the injection site, a history of shoulder surgery within the past 6 months, or known allergies to local anesthetics or corticosteroids will be excluded.

Intervention Protocol:

The ultrasound-guided shoulder PENG block is performed as a routine treatment modality in our clinic for patients non-responsive to conservative therapies. The procedure is conducted under sterile conditions with the patient in the supine position. The affected shoulder is placed in abduction and external rotation. An ultrasound transducer is positioned parallel to the clavicle to visualize the anatomical structures. A block needle is advanced under the subscapularis muscle under direct ultrasound guidance. Following the confirmation of correct needle positioning, a mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is injected into the periarticular nerve endpoints. Outcome Measurements and Data Collection:

Demographic and clinical data will be collected by an expert algologist using the hospital information management system and recorded into dedicated study forms. Clinical parameters will be evaluated at four distinct time points: baseline (pre-procedure), 1st week, 4th week (1 month), and 3rd month post-procedure. Pain severity will be measured using the Numerical Rating Scale (NRS). Shoulder joint function and disability levels will be assessed using the Shoulder Pain and Disability Index (SPADI). Overall patient satisfaction and perceived improvement will be tracked via the Global Perceived Effect (GPE) scale.

Friedman test, depending on the distribution properties. Bonferroni correction will be applied for post-hoc pairwise comparisons, and a p-value less than 0.05 will be considered statistically significant.

Typ studie

Intervenční

Zápis (Odhadovaný)

45

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

    • çankaya
      • Ankara, çankaya, Turecko (Türkiye), 06810
        • Ankara Bilkent City Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 18 years or older.
  • Patients presenting with chronic shoulder pain lasting longer than 3 months.
  • Initial pain intensity score greater than 4 on the Numerical Rating Scale (NRS > 4).
  • Patients who have not responded to conservative or medical treatments.
  • Voluntary acceptance of the ultrasound-guided shoulder PENG block treatment and compliance with the scheduled follow-up protocol.

Exclusion Criteria:

  • Patients currently using anticoagulants or diagnosed with coagulation disorders (bleeding diathesis).
  • Patients with psychomotor or cognitive disorders that prevent cooperative evaluation.
  • Presence of active bacterial infection, open wounds, or infectious discharge at the planned needle injection site.
  • History of shoulder surgery at the intervention site within the last 6 months.
  • Known allergy or hypersensitivity to local anesthetics (lidocaine) or corticosteroids (dexamethasone).
  • Pregnant or breastfeeding patients.
  • Patients who reject the procedure or fail to comply with the scheduled follow-up visits.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: PENG Block Group
Patients with chronic shoulder pain who receive an ultrasound-guided Pericapsular Nerve Group (PENG) block. Under sterile conditions and in the supine position, with the shoulder in abduction and external rotation, an ultrasound transducer is placed parallel to the clavicle. A block needle is advanced under the subscapularis muscle. Following confirmation of the needle position, a mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is administered to the periarticular nerve endpoints.

An ultrasound-guided Pericapsular Nerve Group (PENG) block is administered to target the articular (sensory) branches of the nerves innervating the shoulder joint capsule (suprascapular, axillary, and lateral pectoral nerves) without affecting the motor branches.

The intervention is performed under strict sterile conditions with the patient in the supine position. The affected shoulder is placed in abduction and external rotation. A high-frequency ultrasound transducer is positioned parallel to the clavicle to visualize the anatomical structures. Under direct ultrasound guidance, a block needle is advanced beneath the subscapularis muscle. After confirming the correct needle positioning and ensuring no intravascular placement, a therapeutic mixture of 5 mL of 2% lidocaine and 8 mg of dexamethasone is injected into the periarticular nerve endpoints.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline Numerical Rating Scale (NRS) Score
Časové okno: Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)
The Numerical Rating Scale (NRS) is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The score ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst possible pain." Higher scores represent more severe pain intensity. Pain levels will be evaluated and compared across different time points
Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)
Change from Baseline Shoulder Pain and Disability Index (SPADI) Score
Časové okno: Baseline (pre-procedure), 1st week, 4th week (1st month), and 12th week (3rd month)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire used to measure shoulder pain and disability. It consists of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is scored on a visual analog scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it requires help). The total SPADI score is calculated by averaging the subscale scores and ranges from 0 to 100, where 0 indicates the best possible shoulder function (no pain and disability) and 100 indicates the worst possible shoulder function (severe pain and disability). Higher scores represent greater pain and disability
Baseline (pre-procedure), 1st week, 4th week (1st month), and 12th week (3rd month)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Global Perceived Effect (GPE) Score
Časové okno: Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month).
The Global Perceived Effect (GPE) scale is a patient-reported outcome measure used to assess the patient's subjective perception of recovery or improvement since the beginning of the treatment. It is scored on a Likert-type scale (typically ranging from 1 to 7 or -5 to +5, with specific anchor points). For this study, a standard 7-point Likert scale will be used, where 1 indicates "extremely worsened", 4 indicates "no change", and 7 indicates "extremely improved". Higher scores represent a higher level of patient satisfaction and perceived clinical improvement.
Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: ali çoştu, md, Ankara City Hospital Bilkent

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. října 2026

Dokončení studie (Odhadovaný)

15. října 2026

Termíny zápisu do studia

První předloženo

21. května 2026

První předloženo, které splnilo kritéria kontroly kvality

21. května 2026

První zveřejněno (Aktuální)

26. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Lidocaine and Dexamethasone for PENG Block

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