Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04433377

Collaborator

(none)

Enrollment

Location

Arms

4.1

Actual Duration (Months)

12.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia Pain	Procedure: Suprascapular nerve block Procedure: Subacromial injection	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 28, 2020

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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. 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 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
Experimental: 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. Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).	Procedure: Subacromial injection 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.

Arm

Intervention/Treatment

Experimental: 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. 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

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

Experimental: 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. Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).

Procedure: Subacromial injection

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Visual Analog Scale (VAS) score [baseline, month 1 and month 3]
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 [baseline, month 1 and month 3]
The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.
Functional Independence Measure (FIM) [baseline, month 1 and month 3]
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) [baseline, month 1 and month 3]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul	Bahcelievler	Turkey	34180

Sponsors and Collaborators

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Principal Investigator: Mustafa Corum, MD, Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mustafa Corum, Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04433377

Other Study ID Numbers:

2020-118

First Posted:

Jun 16, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Pain

Hemiplegia

Study Results

No Results Posted as of Oct 19, 2020