The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A

• Status: Completed
• Trial end date: 2021-03-05
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke;

• Diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance;

• Agreement of the patient, family member and / or responsible caregiver to participate in the study.

Exclusion Criteria:

• Pain before stroke in shoulder affected by hemiplegia;

• Previous treatment using TXB-A for painful shoulder;

• Cognitive impairment that hinders assessment and collaboration with treatment;

• Counter indication to the botulinum toxin use; Structured joint deformity in the shoulder affected by pain