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

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Other: Traditional therapeutic exercise; Other: Neurocognitive therapeutic exercise

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • University Hospital "A. Gemelli", Catholic University of the Sacred Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional therapeutic exercise; The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance.	Other: 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
EXPERIMENTAL: 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).	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (ESTIMATE): February 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: pain; shoulder; conservative treatment; neurocognitive therapeutic exercise; traditional therapeutic exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 486/2012