Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03251521
Acronym
DOLOTOX
Enrollment
46
Registered
2017-08-16
Start date
2012-03-31
Completion date
2013-07-31
Last updated
2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Spasticity

Keywords

pain, spasticity, stroke, injection, botulinum toxin A

Brief summary

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

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.

Interventions

OTHERpain 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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evolution of pain intensity during injection with botulinum toxin30 minPain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.

Secondary

MeasureTime frameDescription
Hypoesthesia30 minSemmes Weinstein Monofilament Evaluation
Neuropathic pain30 minDN4 (Neuropathic pain 4 questions)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026