Hemiplegia, SpasticNCT03621423
The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
A study testing ultrasound guided injection in people with Hemiplegia, Spastic, run by Loewenstein Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hemiplegia, Spastic
- What is being tested?
- ultrasound guided injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post stroke patients
- Complaints of pain in hemiplegic shoulder
- Spasticity of subscapularis muscle
- Coherent
- Hebrew speakers
Who cannot join
- Aphasia
- Allergy to botulinum toxin
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the 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
- Conditions
- Hemiplegia, Spastic
- Being tested
- ultrasound guided injection
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided injectionProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia, SpasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motti Ratmansky, MD, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621423
- Sponsor's protocol ID
- 0017-17-LOE
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT03621423
- Acronym / sponsor ID
- 0017-17-LOE
- Conditions
- Hemiplegia, Spastic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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.
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post stroke patients
- Complaints of pain in hemiplegic shoulder
- Spasticity of subscapularis muscle
- Coherent
- Hebrew speakers
Key exclusion criteria (3 listed)
- Aphasia
- Allergy to botulinum toxin
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided injectionPatient 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. | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided injection in people with Hemiplegia, Spastic, run by Loewenstein Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ifat Sandler, MD (97297709143, IfatSa2@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.