Motor Unit Abnormalities After Experimentally Induced Sensitization

NCT04361149 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: MotorUnitsCapsaicin
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Central Sensitisation; Motor Disorders

Keywords

Central Sensitization; Surface Electromyography; Intramuscular Electromyography; Motor Unit; Recruitment

Outcome Measures

Primary Outcomes (1)

• Pain and Presence of Central Sensitization

  Visual Analogue Scale(0-no pain to 10-worst pain imaginable) will measure the amount of burning pain experienced by the intervention

  3 weeks

Secondary Outcomes (2)

• Motor Unit Sequence Difference

  3 months

• Variance of Motor Unit Action Potential

  3 months

Study Arms (2)

Placebo Topical

PLACEBO COMPARATOR

The cream was a lipobase cream, applied topically to the participants upper back, on their left side.

Device: Delsys Trigno Galileo System; Device: Excaliber, Natus Medical; Other: Placebo Cream

Capsaicin Topical

ACTIVE COMPARATOR

Capsaicin Cream (0.075%), applied topically to the participants upper back, on their left side.

Drug: Capsaicin Topical Cream (0.075%); Device: Delsys Trigno Galileo System; Device: Excaliber, Natus Medical

Interventions

Capsaicin Topical Cream (0.075%) DRUG

Capsaicin cream will be administered as a topical skin cream

Also known as: Zostrix HP

Capsaicin Topical

Delsys Trigno Galileo System DEVICE

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

Capsaicin Topical; Placebo Topical

Excaliber, Natus Medical DEVICE

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

Capsaicin Topical; Placebo Topical

Placebo Cream OTHER

Placebo cream will be administered as a topical skin cream

Placebo Topical

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subject with a normal body mass index (18.5 - 24.9)
• a pain visual analogue scale (VAS) below 3 indicating low pain severity

You may not qualify if:

• medical history of inflammatory disorders as rheumatoid arthritis
• neurodegenerative disorders such as Parkinson's disease
• motor neurone diseases as amyotrophic lateral sclerosis, or other neuromuscular disorder

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5S 1A1, Canada

Location

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MeSH Terms

Conditions

Motor Disorders

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Dinesh Kumbahre, PhD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were blinded by the cream treatment given. Both creams were in a concealed, blank, container
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Model Details: A randomized placebo controlled trial using 2 treatments: 1) placebo cream 2) capsaicin cream (0.075%) (Zostrix HP)

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: October 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: March 10, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)