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

NCT03251521 | Completed

• 1 other identifier: 38RC17.251
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-stroke Spasticity

Keywords

pain; spasticity; stroke; injection; botulinum toxin A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hypoesthesia

  30 min

• Neuropathic pain

  30 min

Study Arms (1)

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

Interventions

pain rating during injection with botulinum toxin OTHER

The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection

spasticity post-stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• severe aphasia (severity subscore of the BDAE \<3)
• cognitive impairment or psychiatric disease altering the reliability of pain evaluation
• patient medically unstable.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Pain; Muscle Spasticity; Stroke

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Dominic PERENNOU, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 16, 2017
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share