The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A
Status:
Completed
Trial end date:
2021-03-05
Target enrollment:
Participant gender:
Summary
Stroke is the leading cause of disability in developed countries, and the major cause of
mortality in Brazil.It is associated with low quality of life, disability, decreased muscle
strength and control due to the hypertonia, spasticity. These pathways can develop inadequate
upper and lower limbs functional mechanisms. These changes are linked with disabilities and
painful syndromes.
The shoulder pain relationed after stroke has a variable prevalence from 16 to 84%, from mild
to severe pain and is relationed as a precursor factor of secondary deformities, depression,
longer hospital stay. Its etiology remains controversial with many possibilities as rotator
cuff injuries, glenohumeral dislocation, impact syndrome, bicipital tendinitis, hand shoulder
syndrome, myofascial painful syndrome, presence of spasticity and contractures, adhesive
capsulitis, central pain and others. Its management is controversial and could be done with
physical therapy (kinesiotherapy) intra-articular or local injections (muscles and nerves),
functional electrical stimulation, acupuncture, herbal medicine, tapping, myofascial painful
syndrome treatment, painkillers, anti-inflammatories and antispastic drugs like botulinum
toxin A - tested in few studies, case series, against corticosteroids.
The aim of this study will be to evaluate the effectiveness of the use of 200 units of
abobotulinumtoxin against placebo in both pectoralis major and subscapularis: for reducing
shoulder pain (Visual Analogue Scale, McGill pain scale), active and passive range of
motion(goniometer),upper limb function (Fugl-Meyer test), burden of care questionnaire (apply
to caregivers).
This study is designed as a prospective, double-blind, randomized, controlled study in two
Rehabilitation Centers (Rehabilitation Center from Santa Casa de São Paulo and Hospital de
Clínicas of Universidade de Sao Paulo - Ribeirão Preto).
Phase:
Phase 4
Details
Lead Sponsor:
Faculdade de Ciências Médicas da Santa Casa de São Paulo