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Completed

NCT Number: NCT05161832

Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nocebo

Behavioral

Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.

Placebo

Behavioral

Placebo ultrasound with no diagnosis of injury.

Primary outcomes

  1. Corticospinal excitability

    Time frame: 1 hour

    The corticospinal excitability will be assessed using motor evoked potentials at different intensity of stimulation (from motor threshold to maximal amplitude response).

Secondary outcomes

  1. downward inhibition of pain

    Time frame: 1 hour

    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).

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Acronym: EchoKinésio

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 17, 2021
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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