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Clinical Trials/NCT07485192
NCT07485192CompletedNot Applicable

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

Kars State Hospital1 site in 1 country67 target enrollmentStarted: April 1, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
67
Locations
1
Primary Endpoint
Visual Analog Scale

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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 ≥
  • Patients with vascular conditions such as deep vein thrombosis, phlebitis, varicose veins, or arterial disease.

Outcomes

Primary Outcomes

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

  • 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.)

Investigators

Sponsor
Kars State Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatih Bagcier

Associate Professor

Kars State Hospital

Study Sites (1)

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