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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Switzerland1 site
  • La Tour hospital

    Meyrin, Canton of Geneva, 1217

Other trials in Switzerland

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.

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 groups in NCT06157788
Study groupRoleWhat they receive
Operated groupPatients 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 GroupThe 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.

  1. Task-related brain activation

    Temporal independent component analysis of functional Connectivity

    Measured: At 10 post-operative years

Secondary outcomes (9)
  1. Behavioural responses to apprehension videos

    Minimum 1 (No Apprehension), Maximum 7 (Apprehension)

    Measured: At 10 post-operative years

  2. Changes in grey matter

    Structural changes in grey matter using voxel-based morphometry

    Measured: At 10 post-operative years

  3. 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

  4. Pain on visual analog scale

    From 0 (no pain) to 10 (extreme pain)

    Measured: At 10 post-operative years

  5. Subjective Shoulder Value

    SSV (Subjective Shoulder Value). From 0 (worst) to 100 (best)

    Measured: At 10 post-operative years

  6. Rowe score

    From 0 (worst) to 100 (best)

    Measured: At 10 post-operative years

  7. Simple Shoulder Test

    From 0 (worst) to 12 (best)

    Measured: At 10 post-operative years

  8. Western Ontario Shoulder Instability Index

    From 0 (worst) to 100 (best)

    Measured: At 10 post-operative years

  9. 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.

  1. First posted6 Dec 2023
  2. Study start1 Apr 2022
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

Resources

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)
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

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.

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