Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections

NCT ID: NCT05161832

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2024-01-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kinesiophobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will attend two experimental sessions at the Research Center on Aging of the Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie, Sherbrooke. During the first one, the efficacy of their excitatory and inhibitory mechanisms will be assessed (thermode and cold water bath) and during the second one, their corticospinal excitability will be assessed by transcranial magnetic stimulation (before and during induced pain + placebo or nocebo echography of shoulder). Subjects will be randomized between 2 arms, nocebo (bad fake result) or placebo echography (good fake result). Participants will be allocated using minimization with 2 factors (age and sex). The two sessions will be separated by at least 48 hours.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
The principal investigators will be blinded by anonymization of the subjects and will not be present during the ultrasound. Participants will be notified of their group allocation at the end of their experimental session (after the experiment).

Study Groups

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nocebo

Ultrasound with fake results of rotator cuff injury.

Group Type EXPERIMENTAL

Nocebo

Intervention Type BEHAVIORAL

Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.

placebo

Ultrasound with fake results of the healthy rotator cuff.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Placebo ultrasound with no diagnosis of injury.

Interventions

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Nocebo

Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.

Intervention Type BEHAVIORAL

Placebo

Placebo ultrasound with no diagnosis of injury.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Guillaume Léonard

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillaume Leonard, Pr

Role: STUDY_DIRECTOR

Université de Sherbrooke

Locations

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Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2022-4356

Identifier Type: -

Identifier Source: org_study_id

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