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

Primary Purpose

Hemiplegia, Spastic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound guided injection
Sponsored by
Loewenstein Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia, Spastic

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Post stroke patients

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

Exclusion Criteria:

  • Aphasia
  • Allergy to botulinum toxin
  • Pregnant women

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    The Fugl-Meyer Assessment (FMA)
    a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
    Visual Analogue Scale (VAS)
    a measurement instrument that tries to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain (0-10). The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
    The Brief Pain Inventory - Short Form (BPI-sf)
    a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.

    Full Information

    First Posted
    July 30, 2018
    Last Updated
    August 28, 2018
    Sponsor
    Loewenstein Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03621423
    Brief Title
    The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
    Official Title
    The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2018 (Anticipated)
    Primary Completion Date
    August 1, 2020 (Anticipated)
    Study Completion Date
    August 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Loewenstein Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Treatment using injection of botulinum toxin to the subscapularis spastic muscle has been described in the literature and is a common practice in hemiplegic shoulder. The Injection technic in this pathology is described by using anatomical landmarks of the shoulder region without using medical imaging. On the other hand, injections to the subscapularis muscle has also been described using ultrasound guidance but not for this specific pathology. There are no evidence-based guidelines describing us guided spastic subscapularis muscle injection. Injecting this muscle while in its spastic state requires a modulated approach Harrison et.al described cadaveric dissections of the subscapularis muscle and proposed a technique to reach the motor point zone of this muscle In our study the investigators follow the injection description published by Dong Wook Rha on cadavers based on Harrison's lateral approach description. The Ultrasound enables a correct identification of the target muscle avoiding possible complication of vessel or pulmonary puncture In our study the investigators will try to prove the efficacy of the lateral approach to the subscapularis muscle using ultrasound and nerve stimulator

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia, Spastic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound guided injection
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Modified Ashworth scale (MAS)
    Description
    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
    Time Frame
    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 Outcome Measure Information:
    Title
    The Fugl-Meyer Assessment (FMA)
    Description
    a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
    Time Frame
    The FMA will be assessed twice: the first time before the injection and the second time two weeks following the injection
    Title
    Visual Analogue Scale (VAS)
    Description
    a measurement instrument that tries to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain (0-10). The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
    Time Frame
    The VAS will be assessed twice: the first time before the injection and the second time two weeks following the injection
    Title
    The Brief Pain Inventory - Short Form (BPI-sf)
    Description
    a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.
    Time Frame
    The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    88 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post stroke patients Complaints of pain in hemiplegic shoulder Spasticity of subscapularis muscle Coherent Hebrew speakers Exclusion Criteria: Aphasia Allergy to botulinum toxin Pregnant women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ifat Sandler, MD
    Phone
    97297709143
    Email
    IfatSa2@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Motti Ratmansky, MD
    Phone
    97297709029
    Email
    mottir@clalit.org.il

    12. IPD Sharing Statement

    Learn more about this trial

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

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