Study of Neurocognitive Therapeutic Exercise in the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise

Study Overview
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Brief Summary
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It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Each subject, randomly assigned to either neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2), will be submitted to one-hour session for three times a week for five weeks. The outcome measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from the end of treatment.

Official Title
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Evaluation of the Effectiveness of Neurocognitive Therapeutic Exercise in Pain Control and Functional Recovery of the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Other: Neurocognitive therapeutic exercise
* Other: Traditional therapeutic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with shoulder impingement syndrome established by clinical examination, X-ray in anteroposterior, axillary and outlet views, and magnetic resonance imaging (MRI) or echography. Exclusion Criteria: Rotator cuff and/or subscapularis tendon partial/full-thickness tears, capsulolabral pathology responsive to surgical repair, congenital abnormalities of the acromion, previous surgery on the affected shoulder, inflammatory or neurological (systemic or local) diseases involving shoulder girdles, cognitive or psychiatric disorders, local tumor metastasis or application of radiotherapy, acute infections or osseous tuberculosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional therapeutic exercise<br>The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. | Other: Traditional therapeutic exercise<br>* Different exercises as strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. One-hour session for three times a week for five weeks<br>|
| Experimental: Neurocognitive therapeutic exercise<br>The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). | Other: Neurocognitive therapeutic exercise<br>* Ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). One-hour session for three times a week for five weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire | Assessment of changing of the physical ability and symptoms of the upper extremity | baseline (T0), five weeks (T1), three months (T2), six months (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changing of the Constant-Murley shoulder outcome score | assessment of changing in shoulder range of motion, pain and strength | baseline (T0), five weeks (T1), three months (T2), six months (T3) | 
| changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score | Assessment of changing of the physical ability on daily-living tasks | baseline (T0), five weeks (T1), three months (T2), six months (T3) | 
| changing of the visual analogic scale (VAS) | assessment of changing of shoulder Pain at rest | baseline (T0), five weeks (T1), three months (T2), six months (T3) | 
| changing of the visual analogic scale (VAS) | assessment of changing of shoulder Pain during movements | baseline (T0), five weeks (T1), three months (T2), six months (T3) | 
| changing of the Likert score | assessment of changing in participant satisfaction | baseline (T0), five weeks (T1), three months (T2), six months (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conservative treatment, shoulder, neurocognitive therapeutic exercise, traditional therapeutic exercise, pain