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The goal of this clinical trial is to investigate if physiotherapist supervised training improves neuromuscular control in patients suffering from traumatic anterior shoulder instability. The main question(s) it aims to answer are:
Participants in the training group will undergo a 12 week training-program supervised by a physiotherapist.
Participants in the no-training group will receive a consultation with a shoulder surgeon, where information and general advice regarding the shoulder injury is provided.
Researchers will compare the training group to the no-training group to see if physiotherapist supervised training improves shoulder neuromuscular control in patients with traumatic anterior shoulder instability. The training group will also be compared to a historic group of patients with traumatic anterior shoulder instability, who underwent arthroscopic surgery.
A: Is supervised training in patients with traumatic anterior shoulder instability better in improving neuromuscular control, strength, apprehension and patient reported outcomes when compared to no training.
B: Is supervised training in patients with traumatic anterior shoulder instability better in preventing re-dislocations and need for surgical stabilisation when compared to no training.
C: Is supervised training in patients with traumatic anterior shoulder as good as Bankart surgery in improving neuromuscular control and patient reported outcome when compared to no training.
• Objectives for research question A:
To investigate if, in patients with traumatic anterior shoulder instability, a supervised 12-week training programme is better than no training in improving:
Neuromuscular control
Shoulder internal rotational strength
Shoulder apprehension
Patient reported outcomes
Clinical shoulder instability Outcomes are measured at a) the end of the 12-weeks intervention and b) 6 months after the beginning of the intervention. Furthermore, patient reported outcomes is also measured at 1 and 2 years after the beginning of the intervention.
To investigate if, in traumatic anterior shoulder instability, a supervised 12-week training programme is better than no training in preventing a) re-dislocations and b) need for surgical stabilisation within the first 24 months.
• Objectives for research question C:
To investigate if, in patients with traumatic anterior shoulder instability, a specialised 12-week training programme is as good as arthroscopic Bankart surgery in improving:
For all objectives neuromuscular control is investigated by determining a) shoulder joint position sense (JPS), b) shoulder reaction time, and c) shoulder sway length.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training | Active Comparator | A 12 week physiotherapist supervised training program |
|
| No-training | No Intervention | A short consultation with a designated orthopedic surgeon and a folder with general advice on how to avoid further dislocations and to relieve pain from the shoulder. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapist supervised training | Behavioral | A 12 week physiotherapist supervised training program. The patient will receive supervision by a physiotherapist 6 times during the intervention period. The patient is strongly encouraged to do the assigned training protocol at home 3 times a week. The supervised physiotherapy consists of introduction, review and progression of the assigned exercises. In addition, the patient will receive education and guidance in daily use of the arm and appropriate load on the shoulder. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuromuscular control - Shouldersway | - Shoulder sway. Measured as sway-length (in millimeter). | Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical examination - Shoulder instability | - Shoulder instability tests: Sulcus sign, load and shift, apprehension test, relocation test. | Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |
| Clinical examination - Shoulder range of motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine R Andreasen, MD | Copenhagen University Hospital, Hvidovre | Principal Investigator |
| Kristoffer W Barfod, MD, PhD | Copenhagen University Hospital, Hvidovre | Study Chair |
| Kristoffer W Barfod, MD, PhD | Copenhagen University Hospital, Hvidovre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre | Hvidovre | Capital Region | 2650 | Denmark |
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|
- Shoulder range of motion in flexion, extension, abduction, internal and external rotation |
| Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |
| Strength measure | Shoulder internal rotational strength, measured in Newton. | Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |
| Apprehension measure | An assessment (in degree) of when during an external rotational movement, the patient feels apprehension. | Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |
| Patient-reported outcome measures |
| Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention |
| Redislocations | Patients will be asked on every visit, if they have sustained re-dislocation of their shoulder | Will be tested 3, 6, 12 and 24 months after the beginning of the intervention |
| Neuromuscular control - Joint Position Sense | - Joint position sense for shoulder external rotation. Repositioning error is measured in degree. | Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |
| Neuromuscular control - Reaction Time | - Reaction time. Measured as the time (in milliseconds) it takes the patient to respond to a sudden movement in the shoulder joint. | Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention |