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Quantitative Ultrasound Response of Capsaicin (QUROC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03944889
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dinesh Kumbhare, Toronto Rehabilitation Institute

Brief Summary:

Central Sensitization is an aspect of chronic pain and is associated with over-excitability of the central nervous system. Central Sensitization normally presents itself with other chronic syndromes such as Myofascial Pain Syndrome, so it is difficult to separate the characteristics of the two. The purpose of this study is to determine whether sensitizing healthy muscle using capsaicin, a chilli pepper extract, induces a regional change in ultrasound texture features of the targeted muscle, or the muscles in that are in close proximity. This regional change will be accompanied by electromyography (EMG) recordings to confirm the presence of abnormality. Topical capsaicin and injectable capsaicin will be applied at three different concentrations, 0ug(placebo effect),50ug and 100ug.

Research Questions:

Does sensitization cause a significant regional change in the texture features of the targeted muscle or surrounding muscles? Is this regional change confirmed by abnormality of motor unit firing rates or EMG amplitudes? Is the response dose dependent? Does the induced central sensitization cause a change in force steadiness?

Experimental Protocol:

The physician on site will apply surface and intramuscular EMG sensors to the trapezius. A goniometer will be placed on the subjects arm to detect position. Following this, an ultrasound image of the trapezius, supraspinatus and infraspinatus will be taken.The participant will perform an increasing and decreasing contraction.The subject will then have capsaicin injected into their trapezius or applied onto their skin. The exercise and measurements will then be repeated. The ultrasound will be acquired by the Sonosite ultrasound system. The EMG data will be acquired by the Delsys Trigno EMG system for the surface EMG and the Cadwell Sierra Wave system for the intramuscular EMG. The data will be processed through Delsys EMGworks software and MATLAB. Texture features of the pre and post injection ultrasound images will be compared. Decomposition of motor units will allow for the analysis of motor unit action potential firing rate and amplitudes. Analysis of force steadiness will also be calculated via the goniometer.

Overall, the findings from this study should present preliminary evidence to inform central sensitization's effects on regional muscle structure changes, functional changes and motor unit activity.


Condition or disease Intervention/treatment Phase
Central Sensitisation Drug: Capsaicin Device: Delsys Trigno Galileo System Device: Cadwell Sierra Wave Device: Sonosite Ultrasound Machine Device: Goniometer Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A single-centered, factorial, randomized, placebo-controlled trial with two independent variables (dosage and depth of application).
Masking: Single (Participant)
Masking Description: Participants and investigators will be blinded to the delivered dose; however, the type of capsaicin delivery cannot be blinded from either participants or investigators. The member of the research team conducting the randomization schedule and concealing allocation will have knowledge of and keep track of the doses contained in the containers and vials of the topical and injectable capsaicin, respectively. They will deliver the appropriate dose to the team member implementing the experimental protocol to ensure there is blinding with respect to dose.
Primary Purpose: Basic Science
Official Title: Quantitative Response of Healthy Muscle Following the Induction of Capsaicin
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Placebo Comparator: Placebo Topical
Placebo Cream, applied topically to trapezius muscle
Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Active Comparator: Low Dose, Topical
Capsaicin Cream- low dosage, applied topically to trapezius
Drug: Capsaicin
Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.

Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Active Comparator: High Dose, Topical
Capsaicin Cream- higher dosage, applied topically to trapezius
Drug: Capsaicin
Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.

Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Placebo Comparator: Placebo, Intrafascial
Injection placebo(saline)- injected intrafascially into trapezius
Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Active Comparator: Low Dose, Intrafacial
Injection Capsaicin formulation low dose- injected intrafascially into trapezius
Drug: Capsaicin
Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.

Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Active Comparator: High Dose, Intrafascial
Injection Capsaicin formulation higher dose- injected intrafascially into trapezius
Drug: Capsaicin
Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.

Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Placebo Comparator: Placebo, Intramuscular
Injection placebo (saline) - injected intramuscularly into trapezius
Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Active Comparator: Low Dose, Intramuscular
Injection Capsaicin formulation low dose - injected intramuscularly into trapezius
Drug: Capsaicin
Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.

Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position

Active Comparator: High Dose, Intramuscular
Injection Capsaicin formulation higher dose - injected intramuscularly into trapezius
Drug: Capsaicin
Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.

Device: Delsys Trigno Galileo System
This device is a wireless surface EMG device.

Device: Cadwell Sierra Wave
Intramuscular EMG recording machinery

Device: Sonosite Ultrasound Machine
Ultrasound System

Device: Goniometer
A device to measure angular position




Primary Outcome Measures :
  1. Motor Unit Action Potential Firing Rate [ Time Frame: up to 6 months ]
    Firing rate will be determined using EMGworks software and compared with baseline firing rates.

  2. Root Mean Square EMG values [ Time Frame: up to 6 months ]
    Root mean square values will be compared with baseline values using EMGworks software.

  3. Coefficient of Variation- Force steadiness [ Time Frame: up to 6 months ]
    Force steadiness will be measured by the coefficient of variation (standard deviation/mean) using EMGworks software, validated through the goniometer measurements

  4. Motor Unit Action Potential Amplitudes [ Time Frame: up to 6 months ]
    Amplitudes will be measured from the overall amplitude difference from baseline for each motor unit using EMGworks software

  5. Centroid of Frequency Spectrum [ Time Frame: up to 6 months ]
    Centroid frequency will be measured and the frequency shift of the signal will be compared with baseline. Measured using EMGworks software

  6. Texture Feature Analysis [ Time Frame: up to 6 months ]
    91 features will be extracted using MATLAB, then a reduction of variables will be performed using principal component analysis. The experimental data will be compared with baseline results.


Secondary Outcome Measures :
  1. Severity of pain [ Time Frame: up to 6 months ]
    Pain, or burning sensation measured by the visual analogue scale(0-no pain to 10-worst pain imaginable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy with no past medical history
  • a visual analogue score below 3 indicating low pain severity, ideally who complain of no pain
  • right or left handed
  • normal body mass index
  • have sufficient knowledge of the English language to provide informed consent and understand the protocols
  • agree to sign a consent form.

Exclusion Criteria:

  • history of pain
  • detectable myofascial trigger points upon physical examination
  • history of pain related disturbances such as poor sleep
  • cognitive disturbances, psychiatric disorders
  • history of general medical disorder that may affect the outcome of the study such as diabetes mellitus
  • history of cervical radiculopathies
  • history of inflammatory arthropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944889


Locations
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Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5S 1A1
Sponsors and Collaborators
Toronto Rehabilitation Institute
Investigators
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Principal Investigator: Dinesh M Kumbahre, MD,PhD Toronto Rehabilitation Institute
  Study Documents (Full-Text)

Documents provided by Dinesh Kumbhare, Toronto Rehabilitation Institute:
Publications:
Holobar A, Zazula D. Multichannel blind source separation using convolution kernel compensation. IEEE Transactions on Signal Processing 2007;55(9):4487-96.
Henneman E, Mendell LM. Functional organization of motoneuron pool and its inputs. Handbook of Physiology. The Nervous System. Motor Control. 1981;1:423-507
Huynh H, Feldt LS. Estimation of the Box correction for degrees of freedom from sample data in randomized block and split-plot designs. J Edu Stat 1976;1(1):69-82
Mclean L, Urquhart N. The influence of psychological stressors on myoelectrical signal activity in the shoulder region during a data entry task. Work Stress 2002;16(2):138-53
Westad C. Motor control of the upper trapezius. 2005

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dinesh Kumbhare, Affiliate Scientist, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT03944889    
Other Study ID Numbers: CapsaicinUltrasound
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The University Health Network has a high importance on patient confidentiality. For ethics approval, this was complied with these standards, upholding the patient confidentiality standard at UHN.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dinesh Kumbhare, Toronto Rehabilitation Institute:
MUAP- Motor Unit Action Potential
RMS- Root Mean Square
US-Ultrasound
Additional relevant MeSH terms:
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Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs