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

NCT04470401 | Completed Phase 4

• 1 other identifier: Eduardo Rocha
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Shoulder Pain

Keywords

Shoulder Pain; Botulinum toxins; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Change in Pain in Visual Analogue Scale

  Change of 1.4 mm in Visual Analogue Scale (Scale from 0 to 10mm, where 10 is the worst pain sensation and 0 is pain absence

  1 and 4 months

Secondary Outcomes (2)

• Change of pain in McGill scale

  1 and 4 months

• Change Upper Limb function in Fugl Meyer scale

  1 and 4 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Abobotulinumtoxina 400 IU in 2cc of saline solution

Drug: Saline

Abobotulinumtoxina - 400IU

EXPERIMENTAL

placebo (2cc of saline solution)

Drug: AbobotulinumtoxinA

Interventions

AbobotulinumtoxinA DRUG

application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles

Abobotulinumtoxina - 400IU

Saline DRUG

application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Santa Casa SP

São Paulo, São Paulo, 09040330, Brazil

Location

MeSH Terms

Conditions

Shoulder Pain; Hemiplegia

Interventions

abobotulinumtoxinA; Sodium Chloride

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will receive placebo or botulinum toxin in the same characteristics. Just a assessor of the study will know the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms, a placebo group versus a abobotulinumtoxina (400 IU), to be applied in both muscles (200 IU each) subscapularis and pectoral major

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 14, 2020
• Study Start: June 5, 2019
• Primary Completion: September 5, 2020
• Study Completion: March 5, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-03

Locations

BR (1)