- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567109
Body Schema Alterations in Musculoskeletal Disorders : Effect of Laterality (Schem-TMS)
Body Schema Alterations in Patients Suffering From Musculoskeletal Disorders. Does Disorder Laterality Influence Recruitment of Cerebral Areas Involved in Voluntary Motricity?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Musculoskeletal disorders are a major public health issue. Recent studies showed that body schema alterations are involved in the chronification of those disorders. Those alterations bring the opportunity for new exploration or therapeutic solutions. Our hypothesis is that musculoskeletal disorders lead to motor imagery alterations relative to body schema disorders. Reaction time extension et error rate increase in a hand laterality judgment task would confirm that hypothesis. It is assumed that body schema alterations of patients suffering from musculoskeletal disorders could change with localisation, dependant on disorder's laterality and distality.
It is a monocentric, prospective, case-control trial, with 4 subgroups of 30 patients : shoulder rotator cuff tendinopathy, carpal tunnel syndrome, chronic low back pain, healthy subjects. We compare reaction time and error rate on a hand laterality judgement task. In that task, participants are asked to identify hand right or left laterality, when those hand is presented on a computer screen, by answering with the keyboard. Hands are shown on palmar or dorsal view and with 12 different angles of rotation. An eye-tracking device register participant eye movements during the task.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Angers, France, 49100
- CHU Angers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- normal visual acuity
- social security affiliation
- signing consent
- rotator cuff tendinopathy, chronic low back pain, carpal tunnel syndrome or healthy subject
Exclusion Criteria:
- recent trauma or surgery
- psychiatric or neurological disorder
- psychotropic consumption
- previous experience with motor imagery
- bad french comprehension
- protected persons
- other painful affection than the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Shoulder rotator cuff tendinopathy
unilateral rotator cuff tendinopathy, 3 months or more duration, confirmed by imagery,
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participants are asked to identify laterality of the hand presented on the screen
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chronic low back pain
non specific chronic (3 months) low back pain
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participants are asked to identify laterality of the hand presented on the screen
|
|
carpal tunnel syndrome
unilateral carpal tunnel syndrome, confirmed by electromyogram, 3 months or more duration
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participants are asked to identify laterality of the hand presented on the screen
|
|
control
healthy subjects
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participants are asked to identify laterality of the hand presented on the screen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
error rate at the hand laterality judgment task
Time Frame: 1 hour
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number of errors divided by the total number of hands presented
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1 hour
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reaction time
Time Frame: 1 hour
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time to press on the keyboard the answer "Right" or "Left" after the hand was presented
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1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual strategy
Time Frame: 1 hour
|
assessment of the image's areas most fixed with the eyes
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1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Muscular Diseases
- Neuromuscular Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Back Pain
- Low Back Pain
- Rotator Cuff Injuries
- Carpal Tunnel Syndrome
- Tendinopathy
- Musculoskeletal Diseases
Other Study ID Numbers
- 2018-A00354-51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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