Skip to main content
Clinical Trials/NCT05260125
NCT05260125
Recruiting
Phase 4

Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.

Abant Izzet Baysal University1 site in 1 country50 target enrollmentMarch 15, 2022

Overview

Phase
Phase 4
Intervention
Ultrasound-guided Suprascapular Nerve Block
Conditions
Hemiplegia
Sponsor
Abant Izzet Baysal University
Enrollment
50
Locations
1
Primary Endpoint
Shoulder Range of Motion
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications.

Detailed Description

Hemiplegic shoulder pain is a general term used to describe shoulder pain that occurs after a stroke. It is one of the complications that significantly affects the rehabilitation of patients.The suprascapular nerve takes up 70% of the sensation of the shoulder joint. For this reason, suprascapular nerve block treatment is applied in the treatment of hemiplegic shoulder pain.In patients with hemiplegic shoulder pain, suprascapular nerve block therapy can be performed under ultrasound guidance or using anatomical landmarks. However, there is no study in the literature comparing the effectiveness of ultrasound-guided and unguided suprascapular nerve block in the treatment of hemiplegic shoulder pain Patients with hemiplegic shoulder pain among the patients who received routine conservative rehabilitation treatment in the physical therapy and rehabilitation clinic with the diagnosis of post-stroke hemiplegia will be included in the study. Hemiplegic patients aged 25-75 years, with shoulder pain lasting for 3 months and with a Visual Analogue Scale (VAS) value \> 3 during passive shoulder joint movement will be included in the study. Exclusion criteria from the study will be determined as mini mental test score \< 24, uncontrolled diabetes, coagulopathy, botulinum toxin administration in the last six months, any injection from the shoulder region in the last six months, and hypersensitivity to injection agents. It will be organized as a prospective randomized study. It is planned to include 50 patients in the study. Patients will be randomized into two groups in equal numbers, stratified by age and sex. Patients in group 1 will be applied with ultrasound-guided suprascapular nerve block. Patients in Group 2 will be applied with suprascapular nerve block using defined anatomical points without ultrasound guidance. Initially, demographic data, medical history, stroke etiology, duration of stroke, body mass index, hemiplegic side information of the patients will be obtained. Patients in both groups will be evaluated in terms of shoulder joint range of motion, Visual Analogue Scale, Brunnstrom Stages of Stroke Recovery, Barthel Index, Modified Ashworth Scale, The Beck Depression Inventory before the treatment, at the 1st week, 1st month and 3rd month after the injection.

Registry
clinicaltrials.gov
Start Date
March 15, 2022
End Date
March 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serdar Kilinc

Assistant Professor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

  • Having hemiplegic shoulder pain for 3 months
  • Visual analogue scale score \> 3 during passive shoulder joint movement on the hemiplegic side

Exclusion Criteria

  • Mini mental test score \<24
  • Patients with uncontrolled diabetes, coagulopathy
  • Botulinum toxin administration in the past six months,
  • Any injection in the shoulder region in the last six months
  • Having hypersensitivity to injection agents

Arms & Interventions

Ultrasound-guided Suprascapular Nerve Block

Ultrasound-guided Suprascapular Nerve Block

Intervention: Ultrasound-guided Suprascapular Nerve Block

Anatomical Landmark-guided Suprascapular Nerve Block

Anatomical Landmark-guided Suprascapular Nerve Block

Intervention: Anatomical Landmark-guided Suprascapular Nerve Block

Outcomes

Primary Outcomes

Shoulder Range of Motion

Time Frame: 12 week after suprascapular nerve block

The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.

Visual Analogue Scale

Time Frame: 12 week after suprascapular nerve block

Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

Secondary Outcomes

  • Barthel Index(12 week after suprascapular nerve block)
  • Modified Ashworth Scale(12 week after suprascapular nerve block)
  • Brunnstrom Stages of Stroke Recovery(12 week after suprascapular nerve block)
  • The Beck Depression Inventory(12 week after suprascapular nerve block)

Study Sites (1)

Loading locations...

Similar Trials