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

NCT01785745 | Completed

• 1 other identifier: 486/2012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome

Keywords

conservative treatment; shoulder; neurocognitive therapeutic exercise; traditional therapeutic exercise; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• changing of the Constant-Murley shoulder outcome score

  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

  baseline (T0), five weeks (T1), three months (T2), six months (T3)

• changing of the visual analogic scale (VAS)

  baseline (T0), five weeks (T1), three months (T2), six months (T3)

• changing of the visual analogic scale (VAS)

  baseline (T0), five weeks (T1), three months (T2), six months (T3)

• changing of the Likert score

  baseline (T0), five weeks (T1), three months (T2), six months (T3)

Study Arms (2)

Traditional therapeutic exercise

ACTIVE COMPARATOR

The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance.

Other: Traditional therapeutic exercise

Neurocognitive therapeutic exercise

EXPERIMENTAL

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

Interventions

Neurocognitive therapeutic exercise OTHER

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.

Neurocognitive therapeutic exercise

Traditional therapeutic exercise OTHER

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

Traditional therapeutic exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with shoulder impingement syndrome established by clinical examination, X-ray in anteroposterior, axillary and outlet views, and magnetic resonance imaging (MRI) or echography.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

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

Rome, Italy, Italy

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

IT (1)