Hemiplegia, Spastic Clinical Trial
Official title:
The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 88 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Loewenstein Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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 | 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. | The FMA will be assessed twice: the first time before the injection and the second time two weeks following the injection | |
Secondary | 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 VAS will be assessed twice: the first time before the injection and the second time two weeks following the injection | |
Secondary | 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. | The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04113525 -
Transcutaneous Spinal and Peripheral Stimulation and Wrist Robotic Therapy for Patients With Spastic Stroke
|
N/A | |
Completed |
NCT04613661 -
Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity
|
||
Completed |
NCT03321097 -
Condensed and Distributed Robotic Therapy in Spastic Stroke Post Botulinum Toxin Injection
|
N/A | |
Completed |
NCT03788629 -
THE EFFECTS OF SUBTALAR JOINT MOBILIZATION ON PATIENTS WITH CHRONIC STROKE
|
N/A | |
Completed |
NCT03807557 -
Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection
|
N/A | |
Completed |
NCT04939493 -
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
|
N/A | |
Recruiting |
NCT05557305 -
Changes in Motor and Cognitive Function on Unilateral Spastic Cerebral Palsy, Associated With Videogame Therapy
|
N/A | |
Completed |
NCT05889026 -
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
|
N/A | |
Completed |
NCT01336517 -
Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function
|
N/A | |
Recruiting |
NCT05683158 -
Compensatory Kinematic Movements in Various Directions After Stroke
|
||
Recruiting |
NCT05767437 -
The Effects of Reaching Task Following Selective Trunk Stability Exercise
|
N/A | |
Completed |
NCT04826900 -
Wearable Robotic System and Robotic Mirror Therapy in Spastic Hemiplegia Post Botulinum Toxin Injection
|
N/A |