Clinical trial NCT03621423: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia, Spastic
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The Modified Ashworth scale (MAS)
timeFrame: 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:
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: The FMA will be assessed twice: the first time before the injection and the second time two weeks following the injection
measure: Visual Analogue Scale (VAS)
timeFrame: The VAS will be assessed twice: the first time before the injection and the second time two weeks following the injection
measure: The Brief Pain Inventory - Short Form (BPI-sf)
timeFrame: The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection
Other outcomes:
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