Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients
Primary Purpose
Hemiplegia, Stroke
Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound-guided Suprascapular Nerve Block
Anatomical Landmark-guided Suprascapular Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia
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
Sites / Locations
- Abant Izzet Baysal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrasound-guided Suprascapular Nerve Block
Anatomical Landmark-guided Suprascapular Nerve Block
Arm Description
Ultrasound-guided Suprascapular Nerve Block
Anatomical Landmark-guided Suprascapular Nerve Block
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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).
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).
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05260125
First Posted
February 18, 2022
Last Updated
October 12, 2023
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT05260125
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-guided Suprascapular Nerve Block
Arm Type
Experimental
Arm Description
Ultrasound-guided Suprascapular Nerve Block
Arm Title
Anatomical Landmark-guided Suprascapular Nerve Block
Arm Type
Active Comparator
Arm Description
Anatomical Landmark-guided Suprascapular Nerve Block
Intervention Type
Drug
Intervention Name(s)
Ultrasound-guided Suprascapular Nerve Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Anatomical Landmark-guided Suprascapular Nerve Block
Intervention Description
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
Primary Outcome Measure Information:
Title
Shoulder Range of Motion
Description
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.
Time Frame
Before suprascapular nerve block
Title
Shoulder Range of Motion
Description
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.
Time Frame
1 week after suprascapular nerve block
Title
Shoulder Range of Motion
Description
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.
Time Frame
4 week after suprascapular nerve block
Title
Shoulder Range of Motion
Description
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.
Time Frame
12 week after suprascapular nerve block
Title
Visual Analogue Scale
Description
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time Frame
Before suprascapular nerve block
Title
Visual Analogue Scale
Description
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time Frame
1 week after suprascapular nerve block
Title
Visual Analogue Scale
Description
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time Frame
4 week after suprascapular nerve block
Title
Visual Analogue Scale
Description
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Time Frame
12 week after suprascapular nerve block
Secondary Outcome Measure Information:
Title
Barthel Index
Description
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.
Time Frame
Before suprascapular nerve block
Title
Barthel Index
Description
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.
Time Frame
1 week after suprascapular nerve block
Title
Barthel Index
Description
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.
Time Frame
4 week after suprascapular nerve block
Title
Barthel Index
Description
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.
Time Frame
12 week after suprascapular nerve block
Title
Modified Ashworth Scale
Description
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.
Time Frame
Before suprascapular nerve block
Title
Modified Ashworth Scale
Description
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.
Time Frame
1 week after suprascapular nerve block
Title
Modified Ashworth Scale
Description
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.
Time Frame
4 week after suprascapular nerve block
Title
Modified Ashworth Scale
Description
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.
Time Frame
12 week after suprascapular nerve block
Title
Brunnstrom Stages of Stroke Recovery
Description
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Time Frame
Before suprascapular nerve block
Title
Brunnstrom Stages of Stroke Recovery
Description
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Time Frame
1 week after suprascapular nerve block
Title
Brunnstrom Stages of Stroke Recovery
Description
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Time Frame
4 week after suprascapular nerve block
Title
Brunnstrom Stages of Stroke Recovery
Description
Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.
Time Frame
12 week after suprascapular nerve block
Title
The Beck Depression Inventory
Description
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.
Time Frame
Before suprascapular nerve block
Title
The Beck Depression Inventory
Description
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.
Time Frame
1 week after suprascapular nerve block
Title
The Beck Depression Inventory
Description
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.
Time Frame
4 week after suprascapular nerve block
Title
The Beck Depression Inventory
Description
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.
Time Frame
12 week after suprascapular nerve block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Kılınç
Phone
9050559113181
Email
drserdarkilinc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar kılınç
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar Kılınç
Phone
905055913181
Email
drserdarkilinc@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients
We'll reach out to this number within 24 hrs