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NCT Number: NCT04470401

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Santa Casa SP

São Paulo, 09040330, Brazil

About this study

The principal aim will be the pain evaluation (Visual Analogue Scale and McGill pain scale) with the use of 200 units of abobotulinumtoxin (Dysport) against placebo in both pectoralis major and subscapularis, after 01and 04 months of the procedure The secondary objectives will be analysis the active and passive affected shoulder range of motion (goniometer), the upper limb function (Fugl-Meyer test), Burden of care questionnaire (apply to caregivers) and the use of medicine and therapies.

The sample size was calculated to a alpha error (5%), statistical power (80%) and a decrease of 1.4 points in Visual Analogue Scale, totalizing 10 patients per group, to avoid lack of statistical power due to possible drop out we will recruit 12 patients per group.

The muscles selected for this study are the pectoralis major and subscapularis muscles, each receiving 200U of Dysport® distributed in 2 points, guided by electrical stimulation .The evaluations will be performed in 0, 1 and 4 months after the procedure.

The researchers that will apply and evaluate the patients will be blinded. The patients will be randomized by 6 blocks of four.

The inclusion criteria will be spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke; over 18 years old; 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.

The exclusion criteria will be 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; counterindication to the botulinum toxin use; structured joint deformity in the shoulder affected by pain.

The qualitative variables will be described through percentages of each categories. The quantitative variables will be analyzed for normality by the Komolgorov-Smirnov. The comparison of the value average of the pain variable evaluated by VAS will be performed by the ANOVA test, considering the treatment groups and the moment of evaluation, followed by post hoc comparisons, if the ANOVA test indicates a significant effect group time.The dropouts will be evaluated according to the intention to treat. We will use software Stata11 or similar model

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AbobotulinumtoxinA

Drug

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

Saline

Drug

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

Primary outcomes

  1. Change in Pain in Visual Analogue Scale

    Time frame: 1 and 4 months

    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

Secondary outcomes

  1. Change of pain in McGill scale

    Time frame: 1 and 4 months

    Change of McGill pain scale in at least 02 categories (in a 20 different categories, and decrease of the total number (maximum of 56 points that represent the worst pain.

  2. Change Upper Limb function in Fugl Meyer scale

    Time frame: 1 and 4 months

    Change of function in at least 03 points in Full Meyer scale that represents a maximum value of 66 that represents the upper limb higher function

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Acronym: dolomtox

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 14, 2020
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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