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The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain

NCT03621423 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-29

No results posted yet for this study

Summary

The aim of the study is to describe the efficacy of a new approach to the subscapularis muscle under US guidance for the injection of botulinum toxin in patients that underwent a stroke suffering from hemiplegic shoulder pain.

Pain and spastic shoulder are common findings in hemiplegic patients following a stroke.

The pain interferes with rehabilitation prolonging hospitalization and is related with decreased quality of life.

There is a close relationship between spasticity of the subscapularis muscle and pain The patients show a clinical picture of adduction and internal rotation of the shoulder, elbow and wrist and fingers flexion with a limited external rotation of the shoulder.

The investigators suggest that paralyzing the subscapularis muscle with botulinum toxin may alleviate pain in the hemiplegic shoulder. Best produced when injected in a specific area of the muscle where a higher concentration of motor points exists.

Conditions

  • Hemiplegia, Spastic

Interventions

PROCEDURE

ultrasound guided injection

Patient will be positioned lying on side with the hemiplegic side up. The shoulder will be placed in a flexion and external rotation/abduction position, as possible by the patient, to give the ultrasound probe access to the posterior axillary fold. As previously described in the literature, a line of best fit was calculated by bisection of hypothetical line connecting the inferior spine and the acromial tip, an 18-gauge, 10-cm needle will be inserted under direct ultrasound guidance and by a nerve stimulation . After placing the needle tip in the target point's 100 units of botulinum toxin will be injected.

Sponsors & Collaborators

  • Loewenstein Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-08-01
Completion
2020-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621423 on ClinicalTrials.gov