The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A
Keywords
Abstract
Description
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
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 07/09/2020 |
| Estimated Enrollment Submitted: | 07/12/2020 |
| First Posted: | 07/13/2020 |
| Last Update Submitted: | 07/13/2020 |
| Last Update Posted: | 07/15/2020 |
| Actual Study Start Date: | 06/04/2019 |
| Estimated Primary Completion Date: | 09/04/2020 |
| Estimated Study Completion Date: | 04/04/2021 |
Condition or disease
Intervention/treatment
Drug: Abobotulinumtoxina - 400IU
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo Abobotulinumtoxina 400 IU in 2cc of saline solution | Drug: Placebo application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles |
| Experimental: Abobotulinumtoxina - 400IU placebo (2cc of saline solution) | Drug: Abobotulinumtoxina - 400IU application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Pain in Visual Analogue Scale decrease [1 and 4 months]
Secondary Outcome Measures
1. Decrease of pain in McGill scale [1 and 4 months]
2. Improve Upper Limb function in Fugl Meyer scale [1 and 4 months]
