CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Capsaicin Topical Cream (0.075%) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04361149
NCT04361149Phase 4Completed

Evaluation of Motor Unit Abnormalities After Experimentally Induced Sensitization Using Capsaicin: A Randomized, Double-Blinded, Placebo-Controlled Study

Toronto Rehabilitation Institute·interventional·Posted Apr 24, 2020·Updated Apr 24, 2020

In Brief

A Phase 4 clinical trial evaluating Capsaicin Topical Cream (0.075%), Delsys Trigno Galileo System, and 2 other interventions for Central Sensitisation and Motor Disorders. Completed, enrolled 23 participants across 1 site.

Detailed Summary

Central sensitization is a condition that represents a cascade of neurological adaptations, resulting in an amplification of nociceptive responses from noxious and non-noxious stimuli. This phenomenon presents itself in a vast majority of chronic pain syndromes. Previous evidence has shown that central sensitization results in afferent nociceptor and dorsal horn abnormalities; however, a link between whether this abnormality translates into motor output and more specifically, ventral horn abnormalities, needs to be further explored. Twenty participants were recruited and either a topical capsaicin or a placebo topical cream was applied to their back to induce a transient state of sensitization. Surface electromyography(sEMG) and intramuscular electromyography(iEMG) were used to record motor unit activity from the trapezius and infraspinatus muscles before and after application of capsaicin/placebo. Motor unit recruitment and variability were analyzed in the sEMG and iEMG respectively

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 24, 2020
Enrollment StartOct 1, 2019
Primary CompletionDec 20, 2019
Study CompletionMar 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.2 years ago

Interventions

Capsaicin Topical Cream (0.075%)drug

Capsaicin cream will be administered as a topical skin cream

Delsys Trigno Galileo Systemdevice

A wireless surface EMG device. The sensors will be placed on the trapezius and the infraspinatus muscle, and a recording will be performed.

Excaliber, Natus Medicaldevice

Intramuscular EMG machine. The intramuscular electrode will be inserted into the trapezius and a recording will be performed.

Placebo Creamother

Placebo cream will be administered as a topical skin cream