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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05161832
Other study ID # 2022-4356
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date January 29, 2024

Study information

Verified date June 2024
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date January 29, 2024
Est. primary completion date July 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nocebo
Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.
Placebo
Placebo ultrasound with no diagnosis of injury.

Locations

Country Name City State
Canada Centre de Recherche sur le Vieillissement Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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