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

August 11, 2017 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

46

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients were assessed during routine botulinum toxin injection in the day clinic of our department

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
spasticity post-stroke
pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoesthesia
Time Frame: 30 min
Semmes Weinstein Monofilament Evaluation
30 min
Neuropathic pain
Time Frame: 30 min
DN4 (Neuropathic pain 4 questions)
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (ACTUAL)

August 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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