Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-stroke Spasticity
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 46
- Primary Endpoint
- Evolution of pain intensity during injection with botulinum toxin
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Outcomes
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(30 min)
- Neuropathic pain(30 min)