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

NCT03621423 | Unknown

• 1 other identifier: 0017-17-LOE
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The Modified Ashworth scale (MAS)

  measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. * 0: No increase in muscle tone * 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension

  The MAS will be assessed twice: the first time before the injection and the second time, in order to assess change from baseline measure, two weeks following the injection

Secondary Outcomes (3)

• The Fugl-Meyer Assessment (FMA)

  The FMA will be assessed twice: the first time before the injection and the second time two weeks following the injection

• Visual Analogue Scale (VAS)

  The VAS will be assessed twice: the first time before the injection and the second time two weeks following the injection

• The Brief Pain Inventory - Short Form (BPI-sf)

  The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection

Interventions

ultrasound guided injection PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post stroke patients
• Complaints of pain in hemiplegic shoulder
• Spasticity of subscapularis muscle
• Coherent
• Hebrew speakers

You may not qualify if:

• Aphasia
• Allergy to botulinum toxin
• Pregnant women

Sponsors & Collaborators

• Loewenstein Hospital: lead

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ifat Sandler, MD

CONTACT

97297709143; IfatSa2@clalit.org.il

Motti Ratmansky, MD

CONTACT

97297709029; mottir@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the pain unit

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 8, 2018
• Study Start: November 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08