Post-stroke SpasticityDOLOTOXNCT03251521
Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment
An observational study of Post-stroke Spasticity, run by University Hospital, Grenoble.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Spasticity
- What is being tested?
- pain rating during injection with botulinum toxin
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients were assessed during routine botulinum toxin injection in the day clinic of our department
Who may be able to join
- 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.
Who cannot join
- severe aphasia (severity subscore of the BDAE <3)
- cognitive impairment or psychiatric disease altering the reliability of pain evaluation
- patient medically unstable.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-stroke Spasticity
- Being tested
- pain rating during injection with botulinum toxin
- Keywords
- pain, spasticity, stroke, injection, botulinum toxin A
- Medical subject headings
- Pain, Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain rating during injection with botulinum toxinOther
The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection
| Study group | Role | What they receive |
|---|---|---|
| spasticity post-stroke | pain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale Receives: Other: pain rating during injection with botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 min
Secondary outcomes (2)
Hypoesthesia
Semmes Weinstein Monofilament Evaluation
Measured: 30 min
Neuropathic pain
DN4 (Neuropathic pain 4 questions)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic PERENNOU, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251521
- Sponsor's protocol ID
- 38RC17.251
- Acronym
- DOLOTOX
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Intensity in Different Steps of Injection With Botulinum Toxin in the Treatment of Spasticity in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT03251521
- Acronym / sponsor ID
- DOLOTOX / 38RC17.251
- Conditions
- Post-stroke Spasticity
- Keywords
- pain, spasticity, stroke, injection, botulinum toxin A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spasticity post-stroke | – | Other: pain rating during injection with botulinum toxinpain rating during injection with botulinum toxin The pain intensity was rated verbally on a numeric scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients were assessed during routine botulinum toxin injection in the day clinic of our department
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- severe aphasia (severity subscore of the BDAE <3)
- cognitive impairment or psychiatric disease altering the reliability of pain evaluation
- patient medically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain rating during injection with botulinum toxinThe pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection | Other | spasticity post-stroke |
Primary outcome
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.
2 secondary outcomes
Hypoesthesia
Time frame: 30 min
Neuropathic pain
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Post-stroke Spasticity
Active, not recruiting
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
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A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
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ESTIM-UL: FES for Upper Limb Recovery After Stroke
Stroke, Post-Stroke Spasticity
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Spinal Cord Stimulation for Poststroke Spasticity
Spasticity Post Stroke
Active, not recruitingObservational study
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development
Spasticity as Sequela of Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic PERENNOU, MD, PhD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Post-stroke Spasticity, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of pain intensity during injection with botulinum toxin (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.