KinesiophobiaEchoKinésioNCT05161832
Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections
A study testing Nocebo in people with Kinesiophobia, run by Université de Sherbrooke at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia
- What is being tested?
- Nocebo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2022to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections During Experimental Pain : A Randomised Controlled Trial
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.
- Conditions
- Kinesiophobia
- Being tested
- Nocebo, Placebo
- Keywords
- kinesiophobia, experimental pain, corticospinal excitability, conditioned pain modulation, input output curves
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoceboBehavioural
Nocebo ultrasound with diagnosis of a fake shoulder cuff injury.
PlaceboBehavioural
Placebo ultrasound with no diagnosis of injury.
| Study group | Role | What they receive |
|---|---|---|
| nocebo | Experimental | Ultrasound with fake results of rotator cuff injury. Receives: Behavioral: Nocebo |
| placebo | Active comparator | Ultrasound with fake results of the healthy rotator cuff. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticospinal excitability
The corticospinal excitability will be assessed using motor evoked potentials at different intensity of stimulation (from motor threshold to maximal amplitude response).
Measured: 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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Jan 2022
- Primary completion29 Jul 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Léonard, Université de Sherbrooke
- Investigators
- Guillaume Leonard, Pr, Study director, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161832
- Sponsor's protocol ID
- 2022-4356
- Acronym
- EchoKinésio
- Status last verified
- Jun 2024
- First submitted
- 26 Nov 2021
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections During Experimental Pain : A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05161832
- Acronym / sponsor ID
- EchoKinésio / 2022-4356
- Conditions
- Kinesiophobia
- Keywords
- kinesiophobia, experimental pain, corticospinal excitability, conditioned pain modulation, input output curves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| nocebo | Experimental | Behavioral: NoceboUltrasound with fake results of rotator cuff injury. |
| placebo | Active comparator | Behavioral: PlaceboUltrasound with fake results of the healthy rotator cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- A painful condition or chronic pain
- Neurological disorders
- Shoulder pathology
- Skin diseases
- Capsaicin allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoceboNocebo ultrasound with diagnosis of a fake shoulder cuff injury. | Behavioural | nocebo |
| PlaceboPlacebo ultrasound with no diagnosis of injury. | Behavioural | placebo |
Primary outcome
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).
1 secondary outcome
downward inhibition of pain
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Leonard, Pr study director
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nocebo in people with Kinesiophobia, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticospinal excitability (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.