NCT07485192

Brief Summary

This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) with conventional treatment for hemiplegic shoulder pain. A total of 67 patients aged 45-70 years, treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were randomly assigned to three groups. The first group (n=24) received conventional treatment, the second group (n=22) received conventional treatment plus one session of ultrasound-guided suprascapular nerve block, and the third group (n=21) received conventional treatment plus ESWT applied for 2 weeks, 4 days per week at 12 Hz and 2-3 bars. All groups were evaluated clinically and ultrasonographically before treatment, at 1 month, and at 3 months. Pain intensity was assessed using the visual analog scale, upper extremity motor function with the Fugl-Meyer Motor Scale, and supraspinatus muscle tear size via ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 7, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    The Visual Analog Scale will be used to assess the intensity of pain reported by participants. The scale consists of a 10-cm horizontal line anchored by two extremes: 0 = no pain and 10 = worst imaginable pain. Participants will mark the point on the line that best represents their pain intensity. The score will be determined by measuring the distance (in centimeters) from the "no pain" anchor to the participant's mark, with higher scores indicating greater pain intensity.

    Baseline, 1 month, and 3 months after treatment initiation.

Secondary Outcomes (2)

  • Shoulder range of motion

    Baseline, 1 month, and 3 months after treatment initiation.

  • Presence of supraspinatus tendon tear

    Baseline, 1 month, and 3 months after treatment initiation.

Study Arms (3)

Conventional Treatment

ACTIVE COMPARATOR

Participants received conventional therapy including transcutaneous electrical nerve stimulation, hot pack therapy and joint range of motion, stretching, and progressive resistive exercises

Other: Conventional therapy group

Suprascapular Nerve Block plus Conventional Treatment

EXPERIMENTAL

Participants received one session of ultrasound-guided suprascapular nerve block prior to conventional therapy, followed by the same conventional treatment protocol.

Procedure: suprascapular nerve block

ESWT plus Conventional Treatment

EXPERIMENTAL

Participants received extracorporeal shock wave therapy in addition to the conventional treatment protocol.

Device: Extracorporeal Shock Wave Therapy

Interventions

Conventional treatment including transcutaneous electrical nerve stimulation, hot pack therapy for 4 weeks, and joint range of motion, stretching, and progressive resistive exercises performed 5 days per week for 12 weeks.

Conventional Treatment

A single session of ultrasound-guided suprascapular nerve block administered prior to the conventional therapy program.

Suprascapular Nerve Block plus Conventional Treatment

Extracorporeal shock wave therapy applied at 12 Hz frequency and 2-3 bars pressure, 4 days per week for 2 weeks, in addition to the conventional therapy program.

ESWT plus Conventional Treatment

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with hemorrhagic or ischemic stroke at least 3 months prior to enrollment.
  • Patients with shoulder pain of at least 5 cm on the 10-cm Visual Analog Scale (VAS) following hemiplegia.
  • Patients aged 45-70 years.
  • Patients with partial tear of the supraspinatus muscle/tendon confirmed by ultrasonographic evaluation.

You may not qualify if:

  • Patients with limited cooperation.
  • Patients who received local anesthetic or corticosteroid injection to the shoulder region within the last 3 months.
  • Patients with a history of surgery or radiotherapy in the shoulder region.
  • Patients with pre-existing shoulder pain prior to the diagnosis of stroke.
  • Patients with a cardiac pacemaker.
  • Patients with malignancy or signs of acute inflammation in the treatment area.
  • Patients with coagulation disorders or an INR ≥ 4.
  • Patients with vascular conditions such as deep vein thrombosis, phlebitis, varicose veins, or arterial disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Location

Related Publications (1)

  • Kim SH, Ha KW, Kim YH, Seol PH, Kwak HJ, Park SW, Ryu BJ. Effect of Radial Extracorporeal Shock Wave Therapy on Hemiplegic Shoulder Pain Syndrome. Ann Rehabil Med. 2016 Jun;40(3):509-19. doi: 10.5535/arm.2016.40.3.509. Epub 2016 Jun 29.

    PMID: 27446789BACKGROUND

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • özge özpolat bulut

    Kanuni Sultan Süleyman Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 20, 2026

Study Start

April 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations