Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients
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- What is being studied
- The protocol lists: Ultrasound-guided Suprascapular Nerve Block, Anatomical Landmark-guided Suprascapular Nerve Block.
- Who it may be relevant to
- Registry conditions: Hemiplegia, Stroke. Basic parameters: 25 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients With Hemiplegic Shoulder Pain.
Overview
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.
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.
Interventions
- 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 fos - 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 patient
Primary outcome measures
- Shoulder Range of Motion [Time frame: Before suprascapular nerve block]
- Shoulder Range of Motion [Time frame: 1 week after suprascapular nerve block]
- Shoulder Range of Motion [Time frame: 4 week after suprascapular nerve block]
- Shoulder Range of Motion [Time frame: 12 week after suprascapular nerve block]
- Visual Analogue Scale [Time frame: Before suprascapular nerve block]
- Visual Analogue Scale [Time frame: 1 week after suprascapular nerve block]
- Visual Analogue Scale [Time frame: 4 week after suprascapular nerve block]
- Visual Analogue Scale [Time frame: 12 week after suprascapular nerve block]
Secondary outcome measures (12)
- Barthel Index [Time frame: Before suprascapular nerve block]
- Barthel Index [Time frame: 1 week after suprascapular nerve block]
- Barthel Index [Time frame: 4 week after suprascapular nerve block]
- Barthel Index [Time frame: 12 week after suprascapular nerve block]
- Modified Ashworth Scale [Time frame: Before suprascapular nerve block]
- Modified Ashworth Scale [Time frame: 1 week after suprascapular nerve block]
- Modified Ashworth Scale [Time frame: 4 week after suprascapular nerve block]
- Modified Ashworth Scale [Time frame: 12 week after suprascapular nerve block]
- Brunnstrom Stages of Stroke Recovery [Time frame: Before suprascapular nerve block]
- Brunnstrom Stages of Stroke Recovery [Time frame: 1 week after suprascapular nerve block]
- Brunnstrom Stages of Stroke Recovery [Time frame: 4 week after suprascapular nerve block]
- Brunnstrom Stages of Stroke Recovery [Time frame: 12 week after suprascapular nerve block]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Abant Izzet Baysal University — Bolu
Identifiers
NCT: NCT05260125 · AIBU-FTR-SK-01