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

Not Applicable

Completed

• Conditions: Shoulder Impingement Syndrome
• Interventions: Other: Neurocognitive therapeutic exercise; Other: Traditional therapeutic exercise

• Registration Number: NCT01785745
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-08
• Study Completion: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-05
• Last Update Submitted: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurocognitive therapeutic exercise	Neurocognitive therapeutic exercise	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).
Traditional therapeutic exercise	Traditional therapeutic exercise	The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital "A. Gemelli", Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy