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

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.

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Key information

Conditions

Post-Stroke Spasticity Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

pain rating during injection with botulinum toxin

Other

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

Primary outcomes

Evolution of pain intensity during injection with botulinum toxin

Time frame: 30 min

Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.

Secondary outcomes

Hypoesthesia

Time frame: 30 min

Semmes Weinstein Monofilament Evaluation
Neuropathic pain

Time frame: 30 min

DN4 (Neuropathic pain 4 questions)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients

Acronym: DOLOTOX

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 16, 2017
Registry last updated: Aug 16, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed