- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07485192
Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain (ESWT-HSP)
Study Overview
Status
Conditions
Detailed Description
This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) when added to conventional treatment in patients with hemiplegic shoulder pain.
A total of 67 patients aged 45 to 70 years who were 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 included in the study. Participants were randomly assigned into three groups. The first group (n = 24) received conventional treatment alone. The second group (n = 22) received conventional treatment combined with a single session of ultrasound-guided suprascapular nerve block (SSNB). The third group (n = 21) received conventional treatment combined with extracorporeal shock wave therapy (ESWT), applied for two weeks, four days per week, at a frequency of 12 Hz and an intensity of 2 to 3 bars.
All participants were evaluated clinically and ultrasonographically at baseline, at one month, and at three months. Pain intensity was assessed using the Visual Analog Scale (VAS). Upper extremity motor function was evaluated using the Fugl-Meyer Motor Scale (FMMS). Supraspinatus muscle tear size was measured using ultrasonography.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Başakşehir
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Istanbul, Başakşehir, Turkey (Türkiye)
- Başakşehir Çam and Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Treatment
Participants received conventional therapy including transcutaneous electrical nerve stimulation, hot pack therapy and joint range of motion, stretching, and progressive resistive exercises
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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.
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Experimental: Suprascapular Nerve Block plus Conventional Treatment
Participants received one session of ultrasound-guided suprascapular nerve block prior to conventional therapy, followed by the same conventional treatment protocol.
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A single session of ultrasound-guided suprascapular nerve block administered prior to the conventional therapy program.
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Experimental: ESWT plus Conventional Treatment
Participants received extracorporeal shock wave therapy in addition to the conventional treatment protocol.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline, 1 month, and 3 months after treatment initiation.
|
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.
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Baseline, 1 month, and 3 months after treatment initiation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder range of motion
Time Frame: Baseline, 1 month, and 3 months after treatment initiation.
|
Maximum passive shoulder flexion, abduction, internal rotation, and external rotation, as well as the range of motion at pain onset, were measured using a goniometer while the patient was in the supine position.
Measurements were recorded in degrees, and higher values indicate greater joint range of motion.
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Baseline, 1 month, and 3 months after treatment initiation.
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Presence of supraspinatus tendon tear
Time Frame: Baseline, 1 month, and 3 months after treatment initiation.
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The presence of a supraspinatus tendon tear was evaluated using ultrasonography with a branded ultrasound device.
Imaging was performed by an experienced clinician.
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Baseline, 1 month, and 3 months after treatment initiation.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: özge özpolat bulut, Kanuni Sultan Suleyman Training and Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023.02.49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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