NCT07607691

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

May 21, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

shoulder painpericapsular nerve group block

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (1)

  • Global Perceived Effect (GPE) Score

    Post-procedure 1st week, 4th week (1st month), and 12th week (3rd month).

Study Arms (1)

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.

Drug: Lidocaine and Dexamethasone for PENG Block

Interventions

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.

PENG Block Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, çankaya, 06810, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 15163107BACKGROUND

MeSH Terms

Conditions

BursitisShoulder Pain

Interventions

LidocaineDexamethasone

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • ali çoştu, md

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician in Pain Management

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations