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Completed

NCT Number: NCT07485192

Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain

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.

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Key information

Conditions

Hemiplegic Shoulder Pain

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional therapy group

Other

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.

Suprascapular nerve block

Procedure

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

Extracorporeal Shock Wave Therapy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Presence of supraspinatus tendon tear

    Time frame: Baseline, 1 month, and 3 months after treatment initiation.

    The presence of a supraspinatus tendon tear was evaluated using ultrasonography with a branded ultrasound device. Imaging was performed by an experienced clinician.

Sponsors and collaborators

Lead sponsor

Kars State Hospital

Other

Registry information

Acronym: ESWT-HSP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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