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Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

Primary Purpose

Hemiplegia, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Suprascapular nerve block
Subacromial injection
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Suprascapular nerve block group

Subacromial injection group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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'').

Secondary Outcome Measures

Shoulder ROM
The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.
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
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

Full Information

First Posted
June 9, 2020
Last Updated
October 13, 2020
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04433377
Brief Title
Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain
Official Title
Comparison of the Effects of Ultrasound-guided Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprascapular nerve block group
Arm Type
Experimental
Arm Description
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).
Arm Title
Subacromial injection group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Suprascapular nerve block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Subacromial injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Visual Analog Scale (VAS) score
Description
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'').
Time Frame
baseline, month 1 and month 3
Secondary Outcome Measure Information:
Title
Shoulder ROM
Description
The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.
Time Frame
baseline, month 1 and month 3
Title
Functional Independence Measure (FIM)
Description
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
Time Frame
baseline, month 1 and month 3
Title
EuroQol 5D-3L questionnaire (EQ-5D-3L)
Description
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
Time Frame
baseline, month 1 and month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Corum, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
City
Istanbul
State/Province
Bahcelievler
ZIP/Postal Code
34180
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

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