Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain
ESWT-HSP
1 other identifier
interventional
67
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 7, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedMarch 20, 2026
March 1, 2026
9 months
March 7, 2026
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 COMPARATORParticipants received conventional therapy including transcutaneous electrical nerve stimulation, hot pack therapy and joint range of motion, stretching, and progressive resistive exercises
Suprascapular Nerve Block plus Conventional Treatment
EXPERIMENTALParticipants received one session of ultrasound-guided suprascapular nerve block prior to conventional therapy, followed by the same conventional treatment protocol.
ESWT plus Conventional Treatment
EXPERIMENTALParticipants received extracorporeal shock wave therapy in addition to the conventional treatment protocol.
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.
A single session of ultrasound-guided suprascapular nerve block administered prior to the conventional therapy program.
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.
Eligibility Criteria
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)
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
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
özge özpolat bulut
Kanuni Sultan Süleyman Training and Research Hospital
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