Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment

NCT ID: NCT03251521

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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The aim of the study was to analyze which step of the procedure of toxin botulinum injection is the most painful between skin break-in, electric stimulation, injection and needle withdrawal.

Detailed Description

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Post-stroke spasticity management by botulinum toxin injections may be limited by pain or discomfort at the injection side.

Particularly tracking by electrostimulation, but also skin puncture, toxin injection or needle withdrawal may be painful.

The objective of this study is to define an individual injection strategy in order to limit pain.

Conditions

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Post-stroke Spasticity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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spasticity post-stroke

pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale

pain rating during injection with botulinum toxin

Intervention Type OTHER

The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection

Interventions

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pain rating during injection with botulinum toxin

The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* stroke
* severe upper or lower limb spasticity (Ashworth score ≥ 2 for at least one muscle)
* patients requiring a treatment by botulinum toxin
* patients refusing analgesia for injections.

Exclusion Criteria

* severe aphasia (severity subscore of the BDAE \<3)
* cognitive impairment or psychiatric disease altering the reliability of pain evaluation
* patient medically unstable.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominic PERENNOU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Other Identifiers

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38RC17.251

Identifier Type: -

Identifier Source: org_study_id

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