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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Post-stroke Spasticity

Treatments

Other: pain rating during injection with botulinum toxin

Study type

Observational

Funder types

Other

Identifiers

NCT03251521
38RC17.251

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

46 participants in 1 patient group

spasticity post-stroke
Description:
pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale
Treatment:
Other: pain rating during injection with botulinum toxin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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