Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment
- Conditions
- Post-stroke Spasticity
- Interventions
- Other: pain rating during injection with botulinum toxin
- Registration Number
- NCT03251521
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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.
- severe aphasia (severity subscore of the BDAE <3)
- cognitive impairment or psychiatric disease altering the reliability of pain evaluation
- patient medically unstable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description spasticity post-stroke pain rating during injection with botulinum toxin pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale
- Primary Outcome Measures
Name Time Method Evolution of pain intensity during injection with botulinum toxin 30 min Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.
- Secondary Outcome Measures
Name Time Method Hypoesthesia 30 min Semmes Weinstein Monofilament Evaluation
Neuropathic pain 30 min DN4 (Neuropathic pain 4 questions)