Clinical trial NCT05260125: Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients
Official title: Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hemiplegia
Stroke
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Shoulder Range of Motion
timeFrame: Before suprascapular nerve block
measure: Shoulder Range of Motion
timeFrame: 1 week after suprascapular nerve block
measure: Shoulder Range of Motion
timeFrame: 4 week after suprascapular nerve block
measure: Shoulder Range of Motion
timeFrame: 12 week after suprascapular nerve block
measure: Visual Analogue Scale
timeFrame: Before suprascapular nerve block
measure: Visual Analogue Scale
timeFrame: 1 week after suprascapular nerve block
measure: Visual Analogue Scale
timeFrame: 4 week after suprascapular nerve block
measure: Visual Analogue Scale
timeFrame: 12 week after suprascapular nerve block
Secondary outcomes:
measure: Barthel Index
timeFrame: Before suprascapular nerve block
measure: Barthel Index
timeFrame: 1 week after suprascapular nerve block
measure: Barthel Index
timeFrame: 4 week after suprascapular nerve block
measure: Barthel Index
timeFrame: 12 week after suprascapular nerve block
measure: Modified Ashworth Scale
timeFrame: Before suprascapular nerve block
measure: Modified Ashworth Scale
timeFrame: 1 week after suprascapular nerve block
measure: Modified Ashworth Scale
timeFrame: 4 week after suprascapular nerve block
measure: Modified Ashworth Scale
timeFrame: 12 week after suprascapular nerve block
measure: Brunnstrom Stages of Stroke Recovery
timeFrame: Before suprascapular nerve block
measure: Brunnstrom Stages of Stroke Recovery
timeFrame: 1 week after suprascapular nerve block
measure: Brunnstrom Stages of Stroke Recovery
timeFrame: 4 week after suprascapular nerve block
measure: Brunnstrom Stages of Stroke Recovery
timeFrame: 12 week after suprascapular nerve block
measure: The Beck Depression Inventory
timeFrame: Before suprascapular nerve block
measure: The Beck Depression Inventory
timeFrame: 1 week after suprascapular nerve block
measure: The Beck Depression Inventory
timeFrame: 4 week after suprascapular nerve block
measure: The Beck Depression Inventory
timeFrame: 12 week after suprascapular nerve block
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Serdar kılınç
role: PRINCIPAL_INVESTIGATOR
References: