Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections

NCT05161832 | Completed

• 1 other identifier: 2022-4356
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kinesiophobia

Keywords

kinesiophobia; experimental pain; corticospinal excitability; conditioned pain modulation; input output curves

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• downward inhibition of pain

  1 hour

Study Arms (2)

nocebo

EXPERIMENTAL

Ultrasound with fake results of rotator cuff injury.

Behavioral: Nocebo

placebo

ACTIVE COMPARATOR

Ultrasound with fake results of the healthy rotator cuff.

Behavioral: Placebo

Interventions

Nocebo BEHAVIORAL

Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.

nocebo

Placebo BEHAVIORAL

Placebo ultrasound with no diagnosis of injury.

placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Nocebo Effect

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Placebo Effect; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guillaume Leonard, Pr

  Université de Sherbrooke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 17, 2021
• Study Start: January 15, 2022
• Primary Completion: July 29, 2023
• Study Completion: January 29, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)