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Ultrasound-Guided PENG Block for Chronic Shoulder Pain

21 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

45

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline Numerical Rating Scale (NRS) Score
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Global Perceived Effect (GPE) Score
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: ali çoştu, md, Ankara City Hospital Bilkent

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 października 2026

Ukończenie studiów (Szacowany)

15 października 2026

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2026

Pierwszy wysłany (Rzeczywisty)

26 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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