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

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ClinicalTrials.gov Identifier: NCT05260125
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : December 28, 2022
Sponsor:
Information provided by (Responsible Party):
Serdar Kilinc, Abant Izzet Baysal University

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.

Condition or disease Intervention/treatment Phase
Hemiplegia Stroke Drug: Ultrasound-guided Suprascapular Nerve Block Drug: Anatomical Landmark-guided Suprascapular Nerve Block Phase 4

Detailed Description:

Hemiplegic shoulder pain is a general term used to describe shoulder pain that occurs after a stroke. It is one of the complications that significantly affects the rehabilitation of patients.The suprascapular nerve takes up 70% of the sensation of the shoulder joint. For this reason, suprascapular nerve block treatment is applied in the treatment of hemiplegic shoulder pain.In patients with hemiplegic shoulder pain, suprascapular nerve block therapy can be performed under ultrasound guidance or using anatomical landmarks. However, there is no study in the literature comparing the effectiveness of ultrasound-guided and unguided suprascapular nerve block in the treatment of hemiplegic shoulder pain Patients with hemiplegic shoulder pain among the patients who received routine conservative rehabilitation treatment in the physical therapy and rehabilitation clinic with the diagnosis of post-stroke hemiplegia will be included in the study.

Hemiplegic patients aged 25-75 years, with shoulder pain lasting for 3 months and with a Visual Analogue Scale (VAS) value > 3 during passive shoulder joint movement will be included in the study.

Exclusion criteria from the study will be determined as mini mental test score < 24, uncontrolled diabetes, coagulopathy, botulinum toxin administration in the last six months, any injection from the shoulder region in the last six months, and hypersensitivity to injection agents.

It will be organized as a prospective randomized study. It is planned to include 50 patients in the study. Patients will be randomized into two groups in equal numbers, stratified by age and sex.

Patients in group 1 will be applied with ultrasound-guided suprascapular nerve block.

Patients in Group 2 will be applied with suprascapular nerve block using defined anatomical points without ultrasound guidance.

Initially, demographic data, medical history, stroke etiology, duration of stroke, body mass index, hemiplegic side information of the patients will be obtained.

Patients in both groups will be evaluated in terms of shoulder joint range of motion, Visual Analogue Scale, Brunnstrom Stages of Stroke Recovery, Barthel Index, Modified Ashworth Scale, The Beck Depression Inventory before the treatment, at the 1st week, 1st month and 3rd month after the injection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : February 15, 2023

Arm Intervention/treatment
Experimental: Ultrasound-guided Suprascapular Nerve Block
Ultrasound-guided Suprascapular Nerve Block
Drug: Ultrasound-guided Suprascapular Nerve Block

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.


Active Comparator: Anatomical Landmark-guided Suprascapular Nerve Block
Anatomical Landmark-guided Suprascapular Nerve Block
Drug: Anatomical Landmark-guided Suprascapular Nerve Block

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





Primary Outcome Measures :
  1. Shoulder Range of Motion [ Time Frame: Before suprascapular nerve block ]
    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.

  2. Shoulder Range of Motion [ Time Frame: 1 week after suprascapular nerve block ]
    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.

  3. Shoulder Range of Motion [ Time Frame: 4 week after suprascapular nerve block ]
    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. Shoulder Range of Motion [ Time Frame: 12 week after suprascapular nerve block ]
    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.

  5. Visual Analogue Scale [ Time Frame: Before suprascapular nerve block ]
    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  6. Visual Analogue Scale [ Time Frame: 1 week after suprascapular nerve block ]
    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  7. Visual Analogue Scale [ Time Frame: 4 week after suprascapular nerve block ]
    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

  8. Visual Analogue Scale [ Time Frame: 12 week after suprascapular nerve block ]
    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).


Secondary Outcome Measures :
  1. Barthel Index [ Time Frame: Before suprascapular nerve block ]
    The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.

  2. Barthel Index [ Time Frame: 1 week after suprascapular nerve block ]
    The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.

  3. Barthel Index [ Time Frame: 4 week after suprascapular nerve block ]
    The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.

  4. Barthel Index [ Time Frame: 12 week after suprascapular nerve block ]
    The Barthel index is used to assess activities of daily living. It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs. Scores range from 0-100. A score of 100 represents complete independence, and a score of 0 represents complete dependence.

  5. Modified Ashworth Scale [ Time Frame: Before suprascapular nerve block ]
    Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.

  6. Modified Ashworth Scale [ Time Frame: 1 week after suprascapular nerve block ]
    Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.

  7. Modified Ashworth Scale [ Time Frame: 4 week after suprascapular nerve block ]
    Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.

  8. Modified Ashworth Scale [ Time Frame: 12 week after suprascapular nerve block ]
    Spasticity in the shoulder will be evaluated according to the Modified Ashworth Scale (MAS). The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent increased degree of spasticity.

  9. Brunnstrom Stages of Stroke Recovery [ Time Frame: Before suprascapular nerve block ]
    Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.

  10. Brunnstrom Stages of Stroke Recovery [ Time Frame: 1 week after suprascapular nerve block ]
    Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.

  11. Brunnstrom Stages of Stroke Recovery [ Time Frame: 4 week after suprascapular nerve block ]
    Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.

  12. Brunnstrom Stages of Stroke Recovery [ Time Frame: 12 week after suprascapular nerve block ]
    Brunnstrom Stages of Stroke Recovery will be used to determine the levels of motor function in the upper extremity and hand.

  13. The Beck Depression Inventory [ Time Frame: Before suprascapular nerve block ]
    The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.

  14. The Beck Depression Inventory [ Time Frame: 1 week after suprascapular nerve block ]
    The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.

  15. The Beck Depression Inventory [ Time Frame: 4 week after suprascapular nerve block ]
    The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.

  16. The Beck Depression Inventory [ Time Frame: 12 week after suprascapular nerve block ]
    The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, used instruments for measuring the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05260125


Contacts
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Contact: Serdar Kılınç 9050559113181 drserdarkilinc@hotmail.com

Locations
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Turkey
Abant Izzet Baysal University Recruiting
Bolu, Turkey, 14100
Contact: Serdar Kılınç    905055913181    drserdarkilinc@hotmail.com   
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Principal Investigator: Serdar kılınç Abant Izzet Baysal University
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Responsible Party: Serdar Kilinc, Assistant Professor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT05260125    
Other Study ID Numbers: AIBU-FTR-SK-01
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: December 28, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations