Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections (EchoKinésio)

Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections During Experimental Pain : A Randomised Controlled Trial

Fear of movement (kinesiophobia) is a phenomenon commonly observed in people suffering from chronic pain. The aims of this project are to better understand the neurophysiological basis of this phenomenon, in particular 1) the effect of kinesiophobia (induced by nocebo intervention) on the excitability of corticospinal projections and 2) the association between kinesiophobia and top-down inhibitory mechanisms.

Study Overview

• Status: Completed
• Conditions: Kinesiophobia
• Intervention / Treatment: Behavioral: Nocebo; Behavioral: Placebo

Detailed Description

The study will include 44 healthy (pain-free) participants. Corticospinal measurements will be taken before and after the application of capsaicin cream (experimental pain paradigm). The investigators will manipulate kinesiophobia levels (assessed using the Tampa Kinesiophobia Scale) upward by pretending to diagnose a musculoskeletal problem in half of the participants (nocebo ultrasound), and will measure the efficacy of top-down inhibitory mechanisms using a counter-irritation paradigm (thermode and cold pressor test : the subjects will be subjected to 5 thermal stimulations, 7 mechanical stimulations and 1 water bath at 10°C of the hand) and corticospinal parameters using transcranial magnetic stimulation.

Together, these results will allow a better understanding of the mechanisms associated with a predictor of pain onset (such as kinesiophobia), by studying its interactions with endogenous pain inhibition systems and the motor system, in order to develop relevant prophylactic treatments.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Centre de recherche sur le vieillissement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 18 years old or older
• Healthy Volunteers
• Capable of understanding instructions
• Abstain from tobacco and caffeine 2 hours before data collection
• Abstain from short-acting analgesics 6 hours before data collection

Exclusion Criteria:

• A painful condition or chronic pain
• Neurological disorders
• Shoulder pathology
• Skin diseases
• Capsaicin allergy
• Raynaud's syndrome
• Epilepsy
• Intracranial metallic foreign bodies, hearing aids and cochlear implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nocebo; Ultrasound with fake results of rotator cuff injury.	Behavioral: Nocebo; Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.
Active Comparator: placebo; Ultrasound with fake results of the healthy rotator cuff.	Behavioral: Placebo; Placebo ultrasound with no diagnosis of injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corticospinal excitability	The corticospinal excitability will be assessed using motor evoked potentials at different intensity of stimulation (from motor threshold to maximal amplitude response).	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
downward inhibition of pain	Inhibitory mechanisms will be assessed by comparing pain levels (measured using a computerized visual analog scale [0 = no pain; 10 = worst pain imaginable]) evoked by a test stimulus before and after a conditioning stimulus. Pain levels evoked by the test stimulus before the conditioning stimulus will be subtracted from pain levels evoked by the test stimulus after the pain stimulus, such that a positive score represents increased pain (hyperalgesia) and a negative score represents decreased pain (hypoalgesia, i.e., inhibitory mechanisms).	1 hour

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Study Director: Guillaume Leonard, Pr, Universite de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): July 29, 2023
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: kinesiophobia; conditioned pain modulation; experimental pain; corticospinal excitability; input output curves
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Kinesiophobia
• Other Study ID Numbers: 2022-4356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No