Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients

NCT05260125 | Recruiting Phase 4

• 1 other identifier: AIBU-FTR-SK-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications.

Conditions

Hemiplegia; Stroke

Outcome Measures

Primary Outcomes (8)

• Shoulder Range of Motion

  The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.

  Before suprascapular nerve block

• Shoulder Range of Motion

  The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.

  1 week after suprascapular nerve block

• Shoulder Range of Motion

  The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.

  4 week after suprascapular nerve block

• Shoulder Range of Motion

  The range of motion of the hemiplegic shoulder joint will be measured passively with a goniometer in the flexion, abduction, internal rotation and external rotation directions.

  12 week after suprascapular nerve block

• Visual Analogue Scale

  Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  Before suprascapular nerve block

• Visual Analogue Scale

  Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  1 week after suprascapular nerve block

• Visual Analogue Scale

  Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  4 week after suprascapular nerve block

• Visual Analogue Scale

  Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  12 week after suprascapular nerve block

Secondary Outcomes (16)

• Barthel Index

  Before suprascapular nerve block

• Barthel Index

  1 week after suprascapular nerve block

• Barthel Index

  4 week after suprascapular nerve block

• Barthel Index

  12 week after suprascapular nerve block

• Modified Ashworth Scale

  Before suprascapular nerve block

Study Arms (2)

Ultrasound-guided Suprascapular Nerve Block

EXPERIMENTAL

Ultrasound-guided Suprascapular Nerve Block

Drug: Ultrasound-guided Suprascapular Nerve Block

Anatomical Landmark-guided Suprascapular Nerve Block

ACTIVE COMPARATOR

Anatomical Landmark-guided Suprascapular Nerve Block

Drug: Anatomical Landmark-guided Suprascapular Nerve Block

Interventions

Ultrasound-guided Suprascapular Nerve Block DRUG

For suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used. Injections will be applied to patients in a sitting position and arm by the side. A linear probe with a frequency of 7-8 MHz on the SonoScape A8 ultrasound device will be used for suprascapular block under ultrasound guidance. the ultrasound probe was placed in the coronal plane over the suprascapular fossa. Suprascapular fossa was scanned from medial to lateral side to identify suprascapular nerve. After identification, solution of suprascapular nerve block will be injected into the area around the nerve under the scanning with in-plane technique with a 22 gauge 90 mm spinal needle.

Ultrasound-guided Suprascapular Nerve Block

Anatomical Landmark-guided Suprascapular Nerve Block DRUG

For suprascapular nerve block, a solution consisting of 5 ml 2% lidocaine, 1 ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml), 4 ml saline will be used. Injections will be applied to patients in a sitting position and arm by the side. The suprascapular notch projection will be determined using the anatomical landmark technique defined by Dangoisse et al., and then suprascapular nerve block will be applied with a 22 gauge 90 mm spinal needle to the patients

Anatomical Landmark-guided Suprascapular Nerve Block

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having hemiplegic shoulder pain for 3 months
• Visual analogue scale score \> 3 during passive shoulder joint movement on the hemiplegic side

You may not qualify if:

• Mini mental test score \<24
• Patients with uncontrolled diabetes, coagulopathy
• Botulinum toxin administration in the past six months,
• Any injection in the shoulder region in the last six months
• Having hypersensitivity to injection agents

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Serdar kılınç

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serdar Kılınç

CONTACT

9050559113181; drserdarkilinc@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: March 15, 2022
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

TU (1)