NCT07302711

Brief Summary

Hemiplegic shoulder pain (HSP) is a common and clinically significant complication after stroke that negatively affects rehabilitation outcomes. It is associated with shoulder subluxation, capsular contracture, spasticity, and central pain mechanisms, leading to pain, limited range of motion, and reduced quality of life. The suprascapular nerve (SSN) block has been shown to be effective for shoulder pain management; however, the glenohumeral joint (GHJ) receives innervation from multiple nerves including the axillary, subscapular, and lateral pectoral nerves. The recently described pericapsular/periarticular nerve group (PENG) block targets these articular branches and may provide analgesia with minimal motor impairment. This study aims to evaluate the effects of adding an ultrasound-guided PENG block to conventional physical therapy in patients with post-stroke hemiplegic shoulder pain, focusing on pain intensity, range of motion, and quality of life outcomes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

December 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

December 11, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

PENG blockshoulder joint painHemiplegic shoulder

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity (Numeric Rating Scale, NRS):

    NRS is a scale in which the patient gives points between "0" and "10" for the low back and leg pain felt by the patient, "0" = No pain, "10" = The most severe, unbearable pain

    Baseline, 1 hour, 2 weeks, and 2 months post-intervention. Numeric Rating Scale

Secondary Outcomes (6)

  • Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

    Baseline, 2 weeks, and 2 months

  • Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Questionnaire

    Baseline, 2 weeks, and 2 months

  • Modified Ashworth Scale (MAS)

    Baseline, 2 weeks, and 2 months

  • Stroke-Specific Quality of Life Scale (SS-QOL)

    Baseline, 2 weeks, and 2 months

  • Modified Barthel Index (MBI)

    Baseline, 2 weeks, and 2 months

  • +1 more secondary outcomes

Study Arms (1)

1

All participants will receive a single ultrasound-guided Pericapsular/Periarticular Nerve Group (PENG) block

Procedure: Ultrasound-Guided Pericapsular/Periarticular Nerve Group (PENG) Block

Interventions

Under real-time ultrasound guidance, a 100-mm needle is advanced in-plane between the deltoid muscle and the subscapularis tendon with the patient in the supine position and the affected arm externally rotated and abducted at approximately 45 degrees. A total of 10 mL of 0.25% bupivacaine hydrochloride combined with 4 mg of dexamethasone is injected slowly into the pericapsular space to provide analgesia to the glenohumeral joint.

1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 to 85 years with post-stroke hemiplegic shoulder pain and limited shoulder joint range of motion will be recruited from the Pain Medicine and Physical Therapy Departments of Marmara University Pendik Training and Research Hospital. All participants will have experienced a stroke within the past year and will present with a Numeric Rating Scale (NRS) pain score of 4 or higher at baseline.

You may qualify if:

  • Age between 18 and 85 years
  • Stroke onset less than 1 year
  • Presence of hemiplegic shoulder pain with limited shoulder range of motion confirmed by clinical examination
  • Numeric Rating Scale (NRS) pain score ≥ 4

You may not qualify if:

  • Severe deformity or pathology of the shoulder region
  • Complex regional pain syndrome type I
  • Modified Ashworth Scale score ≥ 3
  • Presence of neglect syndrome
  • Grade 4 glenohumeral joint degeneration
  • Coagulopathy or bleeding disorders
  • Fracture on the affected side
  • Secondary pathology on MRI (malignancy or infection)
  • Presence of pacemaker
  • History of allergic reaction to local anesthetic agents or dexamethasone
  • Shoulder intervention or injection within the past 3 months
  • Major psychiatric illness
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder PainHemiplegia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsParalysisNervous System Diseases

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Savas Sencan, Assoc Prof

CONTACT

Ozlem M Eksi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

December 20, 2025

Primary Completion

February 20, 2026

Study Completion

March 20, 2026

Last Updated

December 24, 2025

Record last verified: 2025-11

Locations