Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENG Block Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine and Dexamethasone for PENG Block | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Numerical Rating Scale (NRS) Score | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Global Perceived Effect (GPE) Score | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ali çoştu, md | Contact | +905427669038 | alicostu@gmail.com | |
| Tolga kaplan, md | Contact | +905304069410 | tolgakaplan1994@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ali çoştu, md | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | çankaya | 06810 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15163107 | Background | Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002062 | Bursitis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D018771 | Arthralgia |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month). |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |