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Clinical Trials/NCT04433377
NCT04433377
Completed
Not Applicable

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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 site in 1 country50 target enrollmentMay 28, 2020
ConditionsHemiplegiaPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change from Baseline in Visual Analog Scale (VAS) score
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 28, 2020
End Date
October 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mustafa Corum

Principal Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

Outcomes

Primary Outcomes

Change from Baseline in Visual Analog Scale (VAS) score

Time Frame: 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 Outcomes

  • 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 Sites (1)

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