Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain

NCT04433377 | Completed

• 1 other identifier: 2020-118
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Shoulder ROM

  baseline, month 1 and month 3

• Functional Independence Measure (FIM)

  baseline, month 1 and month 3

• EuroQol 5D-3L questionnaire (EQ-5D-3L)

  baseline, month 1 and month 3

Study Arms (2)

Suprascapular nerve block group

EXPERIMENTAL

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

Subacromial injection group

EXPERIMENTAL

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

Interventions

Suprascapular nerve block PROCEDURE

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

Suprascapular nerve block group

Subacromial injection PROCEDURE

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.

Subacromial injection group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Pain

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mustafa Corum, MD

  Istanbul Physical Medicine Rehabilitation Training & Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: May 28, 2020
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)