Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

Study Overview
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Brief Summary
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Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder pain reduces range of motion (ROM) and hand function, resulting in limited daily life activity and decreased quality of life. In the literature, the effectiveness of suprascapular nerve block and subacromial injection in hemiplegia patients with shoulder pain has been previously evaluated, but these injection treatments have not been compared. Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia patients with shoulder pain.

Detailed Description
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Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block group In the suprascapular nerve block group, suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector. In the subacromial injection group, subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector. A home exercise program will be given both groups. The exercise program consisted of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).

Official Title
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Comparison of the Effects of Ultrasound-guided Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain: a Randomized Controlled Trial

Conditions
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Hemiplegia, Pain

Intervention / Treatment
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* Procedure: Suprascapular nerve block
* Procedure: Subacromial injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Brunstrom stage 2 to 5 spasticity <4 according to the modified Ashworth scale having hemiplegia less than 12 months Presence of shoulder pain lasting more than 3 months Conservative treatment for painful shoulder before injection Exclusion Criteria: Patients over 75 years old, under 30 years old Anti-coagulant or antiaggregant use Presence of diabetes mellitus Patients who could not be cooperated and Mini-mental Test (MMSE) score <24 Having previously had suprascapular block or subacromial injection Presence of complex regional pain syndrome (type I), The presence of neglect syndrome

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprascapular nerve block group<br>Suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector. Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set). | Procedure: Suprascapular nerve block<br>* A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector<br>|
| Experimental: Subacromial injection group<br>Subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector. Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set). | Procedure: Subacromial injection<br>* A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Visual Analog Scale (VAS) score | Self-reported neck pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt in the past week (0 defines no pain and 10 defines unbearable pain''). | baseline, month 1 and month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder ROM | The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry. | baseline, month 1 and month 3 | 
| Functional Independence Measure (FIM) | Functional independence measure (FIM) will be used to evaluate independence for the activities of daily living. It was developed to measure the results of the rehabilitation on the patient. The higher scores in FIM are interpreted as better functional independence | baseline, month 1 and month 3 | 
| EuroQol 5D-3L questionnaire (EQ-5D-3L) | The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), will be used to evaluate the quality of life | baseline, month 1 and month 3 |