Clinical trial NCT04433377: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Pain
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from Baseline in Visual Analog Scale (VAS) score
timeFrame: baseline, month 1 and month 3
Secondary outcomes:
measure: Shoulder ROM
timeFrame: baseline, month 1 and month 3
measure: Functional Independence Measure (FIM)
timeFrame: baseline, month 1 and month 3
measure: EuroQol 5D-3L questionnaire (EQ-5D-3L)
timeFrame: baseline, month 1 and month 3
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
state: Bahcelievler
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Mustafa Corum, MD
role: PRINCIPAL_INVESTIGATOR
References: