Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433377
• Other study ID #: 2020-118
• Status: Completed
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Pain
• Shoulder Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine and Rehabilitation Training and Research Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Shoulder ROM	The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.	baseline, month 1 and month 3
Secondary	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
Secondary	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