Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621423
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Motti Ratmansky, MD, Loewenstein Hospital

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.


Condition or disease Intervention/treatment Phase
Hemiplegia, Spastic Procedure: ultrasound guided injection Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • 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.



Primary Outcome Measures :
  1. The Modified Ashworth scale (MAS) [ 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 ]

    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 :
  1. The Fugl-Meyer Assessment (FMA) [ Time Frame: The FMA will be assessed twice: the first time before the injection and the second time two weeks following the injection ]
    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.

  2. Visual Analogue Scale (VAS) [ Time Frame: The VAS will be assessed twice: the first time before the injection and the second time two weeks following the injection ]
    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.

  3. The Brief Pain Inventory - Short Form (BPI-sf) [ Time Frame: The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621423


Contacts
Layout table for location contacts
Contact: Ifat Sandler, MD 97297709143 IfatSa2@clalit.org.il
Contact: Motti Ratmansky, MD 97297709029 mottir@clalit.org.il

Sponsors and Collaborators
Loewenstein Hospital
Layout table for additonal information
Responsible Party: Motti Ratmansky, MD, Director of the pain unit, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT03621423    
Other Study ID Numbers: 0017-17-LOE
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Muscle Spasticity
Hemiplegia
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Nervous System Diseases
Paralysis