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CompletedNCT05161832EchoKinésioUpdated Jun 5, 2024

Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections

An interventional study of Nocebo and Placebo in Kinesiophobia, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Kinesiophobia

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Keywords

  • kinesiophobia
  • experimental pain
  • corticospinal excitability
  • conditioned pain modulation
  • input output curves
03

In context

Kinesiophobia

243 studies on the registry are indexed under Kinesiophobia; 89 are open to participants now.

This study's enrollment of 24 is below the median of 51 across 145 interventional studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    nocebo

    Ultrasound with fake results of rotator cuff injury.

    Behavioral: Nocebo

  • Active comparator
    placebo

    Ultrasound with fake results of the healthy rotator cuff.

    Behavioral: Placebo

Interventions

  • BehavioralNocebo

    Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.

  • BehavioralPlacebo

    Placebo ultrasound with no diagnosis of injury.

06

What researchers measure

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).

    Time frame: 1 hour

Secondary outcomes

  1. 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).

    Time frame: 1 hour

07

Study locations

1 site
  • Centre de Recherche sur le Vieillissement
    Sherbrooke, Quebec J1H 4C4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05161832
Lead sponsor
Université de Sherbrooke
Responsible party
Guillaume Léonard (Professor, Université de Sherbrooke) — Principal investigator
First posted
Dec 17, 2021
Start date
Jan 15, 2022
Primary completion
Jul 29, 2023
Completion
Jan 29, 2024
Last update
Jun 5, 2024

Study contacts

Guillaume Leonard, Pr
study director · Université de Sherbrooke

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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