Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260125
• Other study ID #: AIBU-FTR-SK-01
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2024
• Source: Abant Izzet Baysal University
• Contact: Serdar Kilinç
• Phone: 9050559113181
• Email: drserdarkilinc[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Drug:
• Ultrasound-guided Suprascapular Nerve Block
For suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used. Injections will be applied to patients in a sitting position and arm by the side. A linear probe with a frequency of 7-8 MHz on the SonoScape A8 ultrasound device will be used for suprascapular block under ultrasound guidance. the ultrasound probe was placed in the coronal plane over the suprascapular fossa. Suprascapular fossa was scanned from medial to lateral side to identify suprascapular nerve. After identification, solution of suprascapular nerve block will be injected into the area around the nerve under the scanning with in-plane technique with a 22 gauge 90 mm spinal needle.
• Anatomical Landmark-guided Suprascapular Nerve Block
For suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used. Injections will be applied to patients in a sitting position and arm by the side. The suprascapular notch projection will be determined using the anatomical landmark technique defined by Dangoisse et al., and then suprascapular nerve block will be applied with a 22 gauge 90 mm spinal needle to the patients

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Range of Motion	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.	Before suprascapular nerve block
Primary	Shoulder Range of Motion	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.	1 week after suprascapular nerve block
Primary	Shoulder Range of Motion	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.	4 week after suprascapular nerve block
Primary	Shoulder Range of Motion	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.	12 week after suprascapular nerve block
Primary	Visual Analogue Scale	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).	Before suprascapular nerve block
Primary	Visual Analogue Scale	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).	1 week after suprascapular nerve block
Primary	Visual Analogue Scale	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).	4 week after suprascapular nerve block
Primary	Visual Analogue Scale	Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).	12 week after suprascapular nerve block
Secondary	Barthel Index	The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.	Before suprascapular nerve block
Secondary	Barthel Index	The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.	1 week after suprascapular nerve block
Secondary	Barthel Index	The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.	4 week after suprascapular nerve block
Secondary	Barthel Index	The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.	12 week after suprascapular nerve block
Secondary	Modified Ashworth Scale	Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.	Before suprascapular nerve block
Secondary	Modified Ashworth Scale	Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.	1 week after suprascapular nerve block
Secondary	Modified Ashworth Scale	Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.	4 week after suprascapular nerve block
Secondary	Modified Ashworth Scale	Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.	12 week after suprascapular nerve block
Secondary	Brunnstrom Stages of Stroke Recovery	Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.	Before suprascapular nerve block
Secondary	Brunnstrom Stages of Stroke Recovery	Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.	1 week after suprascapular nerve block
Secondary	Brunnstrom Stages of Stroke Recovery	Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.	4 week after suprascapular nerve block
Secondary	Brunnstrom Stages of Stroke Recovery	Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.	12 week after suprascapular nerve block
Secondary	The Beck Depression Inventory	The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.	Before suprascapular nerve block
Secondary	The Beck Depression Inventory	The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.	1 week after suprascapular nerve block
Secondary	The Beck Depression Inventory	The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.	4 week after suprascapular nerve block
Secondary	The Beck Depression Inventory	The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.	12 week after suprascapular nerve block