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

Shoulder Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785745
• Other study ID #: 486/2012
• Status: Completed
• Phase: N/A
• First received: February 1, 2013
• Last updated: February 5, 2013
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Other:
• Neurocognitive therapeutic exercise
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.
• Traditional therapeutic exercise
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

Locations

Country	Name	City	State
Italy	University Hospital "A. Gemelli", Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	changing of the Likert score	assessment of changing in participant satisfaction	baseline (T0), five weeks (T1), three months (T2), six months (T3)	Yes