Shoulder InstabilityNCT06157788
Cerebral Activation and Apprehension in Patients With Shoulder Instability.
An observational study of Shoulder Instability, run by La Tour Hospital at 1 site in Switzerland.
Trial summary
In a similar study, the investigators demonstrated that shoulder stabilization could allow the brain to partially "recover". Patients with shoulder apprehension underwent clinical and fMRI examination before and one year after shoulder stabilization surgery. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Instability
- What is being tested?
- functional Magnetic Resonance Imaging and clinical assessment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2022to 1 Oct 2023
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients were male individuals with anterior glenohumeral instability, who underwent preoperative fMRI, then surgical stabilization by 2 specialized shoulder surgeons, followed by a new fMRI one year postoperatively. The control group consisted in healthy volunteers with no history of shoulder injury, instability, or hyperlaxity, the latter defined as more than 85° of external rotation elbow against waist, or hyperabduction over 105°, who had undergone fMRI at baseline.
Who may be able to join
- The 15 patients operated 10 years ago and the 15 patients used as a control group in a previous analysis.
Who cannot join
- Previous recurrence of instability reported in the past 10 years.
- Major medical disorders (cancer, cardiac illness)
- Sustained head injury
- Psychiatric or neurologic disorders
- Alcohol or drug abuse
- Use of psychotropics, stimulants, and beta-blockers on a regular basis
- Abnormal or non-corrected-to-normal visual acuity
- New contra-indication for fMRI, such as claustrophobia, pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Activation Related to Shoulder Apprehension in Patients With Glenohumeral Instability. A Concise Follow-up of a Previous Report.
In a similar study, the investigators demonstrated that shoulder stabilization could allow the brain to partially "recover". Patients with shoulder apprehension underwent clinical and fMRI examination before and one year after shoulder stabilization surgery. Clinical examination showed a significant improvement in postoperative shoulder function compared with preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex postoperatively, demonstrating that stabilization surgery induced improvements both at the physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal pole and right-occipital cortex activity was associated with good outcome in shoulder performance.
Read the detailed description
Fear, anxiety and anticipation of situations that could lead to a dislocation are essential cognitive processes in shoulder apprehension. Functional magnetic resonance imaging (fMRI) measures brain activity by detecting changes associated with blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. Recently, investigators used fMRI with visual apprehension stimulation to explore neuronal connections and cerebral changes induced by shoulder dislocation. Several cerebral areas were modified during those analyses, representing the different aspects of shoulder apprehension. Specific reorganizations were found in apprehension-related functional connectivity of the primary sensory-motor areas (motor resistance), dorsolateral prefrontal cortex (cognitive control of motor behavior), and the dorsal anterior cingulate cortex/dorsomedial prefrontal cortex and anterior insula (anxiety and emotional regulation).
Those regions are involved in the cognitive control of motor behavior. Hence, there is a motor control anticipation and muscular resistance (protective reflex mechanism), in order to avoid shoulder movement that could lead to dislocation. Another recent study published by Shitara et al. analyzed cerebral changes induced by shoulder dislocation in 14 patients. Although results were similar to the investigators' study, they observed a larger and less specific spectrum of activated cerebral areas, that may be explained by the fact that they projected static and abstract images during fMRI acquisition that may be prone to vaguer and subjective interpretation, and that moreover did not convey the dynamic component inherent to apprehension. In a subsequent study, investigators extended these findings by investigating further structural alterations in patients with shoulder apprehension. The investigators found that fractional anisotropy, representing white matter integrity, was increased in the left internal capsule and partially in the thalamus of studied patients compared to healthy controls. Fractional anisotropy correlated positively with pain visual analogue scale (VAS) scores (p < .05) and negatively with simple shoulder test (SST) scores (p < .05). This suggests an abnormal increased axonal integrity and therefore pathological structural plasticity due to the over-connection of white matter fibers in the motor pathway. These structural alterations affect several dimensions of shoulder apprehension as pain perception and performance in daily life.
The neuronal changes previously mentioned and presented in shoulder apprehension can also be assessed in daily clinical practice. Indeed, Cunningham et al. correlated clinical scores and tests (Rowe, pain VAS, SST, subjective shoulder value (SSV), WOSI) with functional cerebral imaging in patients with shoulder apprehension. Their hypothesis was that it might be possible to simplify shoulder instability scores as it has been previously possible with rotator cuff and SLAP lesions, and that at least one score could encompass the spectrum of these cerebral alterations. They found that the Rowe score integrated several aspects of apprehension, notably the motor and sensory functions, as well as pain anticipation and attention. This could be explained by the fact that the Rowe score is the only tested score that integrates range of motion. This also provides the ability to evaluate motor component (stability and motion) and cognitive component (perceived pain) of shoulder apprehension. Pain VAS and WOSI seemed to correlate with less brain networks compared to the Rowe. This could be explained by the fact that their assessment is focused only on cognitive aspects (pain for pain VAS, shoulder function in everyday life activities for WOSI), and that they do not integrate pure shoulder motion. SST and SSV were not found to be associated with brain network alterations, which is corroborated by the fact that they are general shoulder scores and were not specifically validated for instability.
In a similar study, the investigators demonstrated that shoulder stabilization could allow the brain to partially "recover". Patients with shoulder apprehension underwent clinical and fMRI examination before and one year after shoulder stabilization surgery. Clinical examination showed a significant improvement in postoperative shoulder function compared with preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex postoperatively, demonstrating that stabilization surgery induced improvements both at the physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal pole and right-occipital cortex activity was associated with good outcome in shoulder performance.
- Conditions
- Shoulder Instability
- Being tested
- functional Magnetic Resonance Imaging and clinical assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional Magnetic Resonance Imaging and clinical assessmentDiagnostic test
- fMRI task: In the active condition, video cues were utilized (lasting 10s) depicting everyday activities that trigger shoulder apprehension. Control videos were created to match the previous content, except for the absence of cues inducing shoulder apprehension. Following each video, a visual analog scale appeared for a duration of 2.5s, and participant were asked to rate the level of perceived apprehension, using an MRI-compatible response box. The rating scale consisted of nine steps, ranging from no apprehension to high apprehension. After providing their rating, participants had a rest period during which a fixation cross was displayed visually for 17.5s. Apprehension and control videos were shown in a pseudo-randomized fashion.
- General Linear Model Analysis of Task-Related Activation
- TICA Analysis of Functional Connectivity
- White Matter TBSS of DTI Data
- Voxel-based morphometry analysis of T1 images
| Study group | Role | What they receive |
|---|---|---|
| Operated group | Patients were male individuals with anterior glenohumeral instability, who underwent preoperative fMRI, then surgical stabilization by 2 specialized shoulder surgeons, followed by a new fMRI one year postoperatively. Receives: Diagnostic Test: functional Magnetic Resonance Imaging and clinical assessment | |
| Control Group | The control group consisted in healthy volunteers with no history of shoulder injury, instability, or hyperlaxity, the latter defined as more than 85° of external rotation elbow against waist, or hyperabduction over 105°, who had undergone fMRI at baseline. Receives: Diagnostic Test: functional Magnetic Resonance Imaging and clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task-related brain activation
Temporal independent component analysis of functional Connectivity
Measured: At 10 post-operative years
Secondary outcomes (9)
Behavioural responses to apprehension videos
Minimum 1 (No Apprehension), Maximum 7 (Apprehension)
Measured: At 10 post-operative years
Changes in grey matter
Structural changes in grey matter using voxel-based morphometry
Measured: At 10 post-operative years
Changes in white matter
structural changes in white matter using tract-based spatial statistics analysis with multimodal Magnetic Resonance imaging
Measured: At 10 post-operative years
Pain on visual analog scale
From 0 (no pain) to 10 (extreme pain)
Measured: At 10 post-operative years
Subjective Shoulder Value
SSV (Subjective Shoulder Value). From 0 (worst) to 100 (best)
Measured: At 10 post-operative years
Rowe score
From 0 (worst) to 100 (best)
Measured: At 10 post-operative years
Simple Shoulder Test
From 0 (worst) to 12 (best)
Measured: At 10 post-operative years
Western Ontario Shoulder Instability Index
From 0 (worst) to 100 (best)
Measured: At 10 post-operative years
Single Assessment numeric evaluation score
Single Assessment numeric evaluation (SANE). From 0 (worst) to 100 (best)
Measured: At 10 post-operative years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Apr 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandre Lädermann, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157788
- Sponsor's protocol ID
- 2022-00135
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haller S, Cunningham G, Laedermann A, Hofmeister J, Van De Ville D, Lovblad KO, Hoffmeyer P. Shoulder apprehension impacts large-scale functional brain networks. AJNR Am J Neuroradiol. 2014 Apr;35(4):691-7. doi: 10.3174/ajnr.A3738. Epub 2013 Oct 3.
PubMed 24091445
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Activation Related to Shoulder Apprehension in Patients With Glenohumeral Instability. A Concise Follow-up of a Previous Report.
- ClinicalTrials.gov ID
- NCT06157788
- Acronym / sponsor ID
- 2022-00135
- Conditions
- Shoulder Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 6 Dec 2023 (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.
In a similar study, the investigators demonstrated that shoulder stabilization could allow the brain to partially "recover". Patients with shoulder apprehension underwent clinical and fMRI examination before and one year after shoulder stabilization surgery. Clinical examination showed a significant improvement in postoperative shoulder function compared with preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex postoperatively, demonstrating that stabilization surgery induced improvements both at the physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal pole and right-occipital cortex activity was associated with good outcome in shoulder performance.
Detailed description
Fear, anxiety and anticipation of situations that could lead to a dislocation are essential cognitive processes in shoulder apprehension. Functional magnetic resonance imaging (fMRI) measures brain activity by detecting changes associated with blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. Recently, investigators used fMRI with visual apprehension stimulation to explore neuronal connections and cerebral changes induced by shoulder dislocation. Several cerebral areas were modified during those analyses, representing the different aspects of shoulder apprehension. Specific reorganizations were found in apprehension-related functional connectivity of the primary sensory-motor areas (motor resistance), dorsolateral prefrontal cortex (cognitive control of motor behavior), and the dorsal anterior cingulate cortex/dorsomedial prefrontal cortex and anterior insula (anxiety and emotional regulation).
Those regions are involved in the cognitive control of motor behavior. Hence, there is a motor control anticipation and muscular resistance (protective reflex mechanism), in order to avoid shoulder movement that could lead to dislocation. Another recent study published by Shitara et al. analyzed cerebral changes induced by shoulder dislocation in 14 patients. Although results were similar to the investigators' study, they observed a larger and less specific spectrum of activated cerebral areas, that may be explained by the fact that they projected static and abstract images during fMRI acquisition that may be prone to vaguer and subjective interpretation, and that moreover did not convey the dynamic component inherent to apprehension. In a subsequent study, investigators extended these findings by investigating further structural alterations in patients with shoulder apprehension. The investigators found that fractional anisotropy, representing white matter integrity, was increased in the left internal capsule and partially in the thalamus of studied patients compared to healthy controls. Fractional anisotropy correlated positively with pain visual analogue scale (VAS) scores (p < .05) and negatively with simple shoulder test (SST) scores (p < .05). This suggests an abnormal increased axonal integrity and therefore pathological structural plasticity due to the over-connection of white matter fibers in the motor pathway. These structural alterations affect several dimensions of shoulder apprehension as pain perception and performance in daily life.
The neuronal changes previously mentioned and presented in shoulder apprehension can also be assessed in daily clinical practice. Indeed, Cunningham et al. correlated clinical scores and tests (Rowe, pain VAS, SST, subjective shoulder value (SSV), WOSI) with functional cerebral imaging in patients with shoulder apprehension. Their hypothesis was that it might be possible to simplify shoulder instability scores as it has been previously possible with rotator cuff and SLAP lesions, and that at least one score could encompass the spectrum of these cerebral alterations. They found that the Rowe score integrated several aspects of apprehension, notably the motor and sensory functions, as well as pain anticipation and attention. This could be explained by the fact that the Rowe score is the only tested score that integrates range of motion. This also provides the ability to evaluate motor component (stability and motion) and cognitive component (perceived pain) of shoulder apprehension. Pain VAS and WOSI seemed to correlate with less brain networks compared to the Rowe. This could be explained by the fact that their assessment is focused only on cognitive aspects (pain for pain VAS, shoulder function in everyday life activities for WOSI), and that they do not integrate pure shoulder motion. SST and SSV were not found to be associated with brain network alterations, which is corroborated by the fact that they are general shoulder scores and were not specifically validated for instability.
In a similar study, the investigators demonstrated that shoulder stabilization could allow the brain to partially "recover". Patients with shoulder apprehension underwent clinical and fMRI examination before and one year after shoulder stabilization surgery. Clinical examination showed a significant improvement in postoperative shoulder function compared with preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex postoperatively, demonstrating that stabilization surgery induced improvements both at the physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal pole and right-occipital cortex activity was associated with good outcome in shoulder performance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operated group | – | Diagnostic Test: functional Magnetic Resonance Imaging and clinical assessmentPatients were male individuals with anterior glenohumeral instability, who underwent preoperative fMRI, then surgical stabilization by 2 specialized shoulder surgeons, followed by a new fMRI one year postoperatively. |
| Control Group | – | Diagnostic Test: functional Magnetic Resonance Imaging and clinical assessmentThe control group consisted in healthy volunteers with no history of shoulder injury, instability, or hyperlaxity, the latter defined as more than 85° of external rotation elbow against waist, or hyperabduction over 105°, who had undergone fMRI at baseline. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were male individuals with anterior glenohumeral instability, who underwent preoperative fMRI, then surgical stabilization by 2 specialized shoulder surgeons, followed by a new fMRI one year postoperatively. The control group consisted in healthy volunteers with no history of shoulder injury, instability, or hyperlaxity, the latter defined as more than 85° of external rotation elbow against waist, or hyperabduction over 105°, who had undergone fMRI at baseline.
Key inclusion criteria (1 listed)
- The 15 patients operated 10 years ago and the 15 patients used as a control group in a previous analysis.
Key exclusion criteria (8 listed)
- Previous recurrence of instability reported in the past 10 years.
- Major medical disorders (cancer, cardiac illness)
- Sustained head injury
- Psychiatric or neurologic disorders
- Alcohol or drug abuse
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 |
|---|---|---|
| functional Magnetic Resonance Imaging and clinical assessment* fMRI task: In the active condition, video cues were utilized (lasting 10s) depicting everyday activities that trigger shoulder apprehension. Control videos were created to match the previous content, except for the absence of cues inducing shoulder apprehension. Following each video, a visual analog scale appeared for a duration of 2.5s, and participant were asked to rate the level of perceived apprehension, using an MRI-compatible response box. The rating scale consisted of nine steps, ranging from no apprehension to high apprehension. After providing their rating, participants had a rest period during which a fixation cross was displayed visually for 17.5s. Apprehension and control videos were shown in a pseudo-randomized fashion. * General Linear Model Analysis of Task-Related Activation * TICA Analysis of Functional Connectivity * White Matter TBSS of DTI Data * Voxel-based morphometry analysis of T1 images | Diagnostic test | Control Group, Operated group |
Primary outcome
Task-related brain activation
Time frame: At 10 post-operative years
Temporal independent component analysis of functional Connectivity
9 secondary outcomes
Behavioural responses to apprehension videos
Time frame: At 10 post-operative years
Changes in grey matter
Time frame: At 10 post-operative years
Changes in white matter
Time frame: At 10 post-operative years
Pain on visual analog scale
Time frame: At 10 post-operative years
Subjective Shoulder Value
Time frame: At 10 post-operative years
Rowe score
Time frame: At 10 post-operative years
Simple Shoulder Test
Time frame: At 10 post-operative years
Western Ontario Shoulder Instability Index
Time frame: At 10 post-operative years
Single Assessment numeric evaluation score
Time frame: At 10 post-operative years
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 14 Dec 2023.
- Background: PubMed 24091445Haller S, Cunningham G, Laedermann A, Hofmeister J, Van De Ville D, Lovblad KO, Hoffmeyer P. Shoulder apprehension impacts large-scale functional brain networks. AJNR Am J Neuroradiol. 2014 Apr;35(4):691-7. doi: 10.3174/ajnr.A3738. Epub 2013 Oct 3.
- 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 Shoulder Instability, run by La Tour Hospital at 1 site in Switzerland.
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 1 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 14 Dec 2023. 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 Switzerland. 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?
Task-related brain activation (time frame: At 10 post-operative years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157788, which also lists 1 linked publication.
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 14 Dec 2023.