Musculoskeletal DisorderSchem-TMSNCT03567109
Body Schema Alterations in Musculoskeletal Disorders : Effect of Laterality
An observational study of Musculoskeletal Disorder and Rotator Cuff Tendinitis, run by University Hospital, Angers at 1 site in France.
Trial summary
This study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. Reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Disorder, Rotator Cuff Tendinitis, Chronic Low Back Pain
- What is being tested?
- hand laterality judgment task
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2018to 12 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: patients refered to the Hospital University of Angers or the Hand Center in Trelazé for one of the musculoskeletal disorders meeting the inclusion criterias.
Who may be able to join
- normal visual acuity
- social security affiliation
- signing consent
- rotator cuff tendinopathy, chronic low back pain, carpal tunnel syndrome or healthy subject
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Schema Alterations in Patients Suffering From Musculoskeletal Disorders. Does Disorder Laterality Influence Recruitment of Cerebral Areas Involved in Voluntary Motricity?
This study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. Reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder.
Read the 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.
- Conditions
- Musculoskeletal Disorder, Rotator Cuff Tendinitis, Chronic Low Back Pain, Carpal Tunnel Syndrome
- Being tested
- hand laterality judgment task
- Medical subject headings
- Musculoskeletal Diseases, Rotator Cuff Injuries, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand laterality judgment taskOther
participants are asked to identify laterality of the hand presented on the screen
| Study group | Role | What they receive |
|---|---|---|
| Shoulder rotator cuff tendinopathy | unilateral rotator cuff tendinopathy, 3 months or more duration, confirmed by imagery, Receives: Other: hand laterality judgment task | |
| chronic low back pain | non specific chronic (3 months) low back pain Receives: Other: hand laterality judgment task | |
| carpal tunnel syndrome | unilateral carpal tunnel syndrome, confirmed by electromyogram, 3 months or more duration Receives: Other: hand laterality judgment task | |
| control | healthy subjects Receives: Other: hand laterality judgment task |
What is being measured
The primary outcome is the main question the study is designed to answer.
error rate at the hand laterality judgment task
number of errors divided by the total number of hands presented
Measured: 1 hour
reaction time
time to press on the keyboard the answer "Right" or "Left" after the hand was presented
Measured: 1 hour
Secondary outcomes (1)
visual strategy
assessment of the image's areas most fixed with the eyes
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 posted25 Jun 2018
- Study start13 Jul 2018
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567109
- Sponsor's protocol ID
- 2018-A00354-51
- Acronym
- Schem-TMS
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2018
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Schema Alterations in Patients Suffering From Musculoskeletal Disorders. Does Disorder Laterality Influence Recruitment of Cerebral Areas Involved in Voluntary Motricity?
- ClinicalTrials.gov ID
- NCT03567109
- Acronym / sponsor ID
- Schem-TMS / 2018-A00354-51
- Conditions
- Musculoskeletal Disorder, Rotator Cuff Tendinitis, Chronic Low Back Pain, Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 25 Jun 2018 (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.
This study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. Reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shoulder rotator cuff tendinopathy | – | Other: hand laterality judgment taskunilateral rotator cuff tendinopathy, 3 months or more duration, confirmed by imagery, |
| chronic low back pain | – | Other: hand laterality judgment tasknon specific chronic (3 months) low back pain |
| carpal tunnel syndrome | – | Other: hand laterality judgment taskunilateral carpal tunnel syndrome, confirmed by electromyogram, 3 months or more duration |
| control | – | Other: hand laterality judgment taskhealthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients refered to the Hospital University of Angers or the Hand Center in Trelazé for one of the musculoskeletal disorders meeting the inclusion criterias.
Key inclusion criteria (4 listed)
- normal visual acuity
- social security affiliation
- signing consent
- rotator cuff tendinopathy, chronic low back pain, carpal tunnel syndrome or healthy subject
Key exclusion criteria (7 listed)
- recent trauma or surgery
- psychiatric or neurological disorder
- psychotropic consumption
- previous experience with motor imagery
- bad french comprehension
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 |
|---|---|---|
| hand laterality judgment taskparticipants are asked to identify laterality of the hand presented on the screen | Other | Shoulder rotator cuff tendinopathy, carpal tunnel syndrome, chronic low back pain, control |
Primary outcome
error rate at the hand laterality judgment task
Time frame: 1 hour
number of errors divided by the total number of hands presented
reaction time
Time frame: 1 hour
time to press on the keyboard the answer "Right" or "Left" after the hand was presented
1 secondary outcome
visual strategy
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 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Disorder and Rotator Cuff Tendinitis, run by University Hospital, Angers at 1 site in France.
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 4 inclusion and 7 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 11 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 France. 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?
error rate at the hand laterality judgment task (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 11 Jun 2024.