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
About this trial
This is an interventional treatment trial for Hemiplegia, Spastic
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
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
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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