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

Post-stroke Spasticity Clinical Trial

— DOLOTOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251521
• Other study ID #: 38RC17.251
• Status: Completed
• Phase: N/A
• First received: August 11, 2017
• Last updated: August 11, 2017
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-stroke Spasticity
• Stroke

Intervention

Other:
• pain 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of pain intensity during injection with botulinum toxin	Pain intensity in different steps of the procedure of toxin botulinum injection: skin break-in, electric stimulation, injection and needle withdrawal.	30 min
Secondary	Hypoesthesia	Semmes Weinstein Monofilament Evaluation	30 min
Secondary	Neuropathic pain	DN4 (Neuropathic pain 4 questions)	30 min