- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07607691
Ultrasound-Guided PENG Block for Chronic Shoulder Pain
Evaluation of the Analgesic Efficacy and Functional Outcomes of Ultrasound-Guided PENG Block in Chronic Shoulder Pain
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: ali çoştu, md
- Numero di telefono: +905427669038
- Email: alicostu@gmail.com
Backup dei contatti dello studio
- Nome: Tolga kaplan, md
- Numero di telefono: +905304069410
- Email: tolgakaplan1994@gmail.com
Luoghi di studio
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çankaya
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Ankara, çankaya, Turchia (Türkiye), 06810
- Ankara Bilkent City Hospital
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Contatto:
- ali çoştu, md
- Numero di telefono: +905427669038
- Email: alicostu@gmail.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline Numerical Rating Scale (NRS) Score
Lasso di tempo: Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)
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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
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Baseline (pre-procedure), post-procedure 30th minute, 1st week, 4th week (1st month), and 12th week (3rd month)
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Change from Baseline Shoulder Pain and Disability Index (SPADI) Score
Lasso di tempo: 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
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Baseline (pre-procedure), 1st week, 4th week (1st month), and 12th week (3rd month)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Global Perceived Effect (GPE) Score
Lasso di tempo: 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.
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Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month).
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: ali çoştu, md, Ankara City Hospital Bilkent
Pubblicazioni e link utili
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie articolari
- Artralgia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Borsite
- Dolore alla spalla
- Prodotti chimici organici
- Composti policiclici
- Anilides
- Amides
- Composti di anilina
- Ammine
- Acetanilides
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Incintadienetrioli
- Desametasone
- Lidocaina
Altri numeri di identificazione dello studio
- E2-26-14592
Piano per i dati dei singoli partecipanti (IPD)
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