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

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neurocognitive therapeutic exercise
Traditional therapeutic exercise
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring conservative treatment, shoulder, neurocognitive therapeutic exercise, traditional therapeutic exercise, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional therapeutic exercise

Neurocognitive therapeutic exercise

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

changing of the Constant-Murley shoulder outcome score
assessment of changing in shoulder range of motion, pain and strength
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
changing of the visual analogic scale (VAS)
assessment of changing of shoulder Pain at rest
changing of the visual analogic scale (VAS)
assessment of changing of shoulder Pain during movements
changing of the Likert score
assessment of changing in participant satisfaction

Full Information

First Posted
February 1, 2013
Last Updated
February 5, 2013
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01785745
Brief Title
Study of Neurocognitive Therapeutic Exercise in the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
conservative treatment, shoulder, neurocognitive therapeutic exercise, traditional therapeutic exercise, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional therapeutic exercise
Arm Type
Active Comparator
Arm Description
The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance.
Arm Title
Neurocognitive therapeutic exercise
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Neurocognitive therapeutic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional therapeutic exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
Assessment of changing of the physical ability and symptoms of the upper extremity
Time Frame
baseline (T0), five weeks (T1), three months (T2), six months (T3)
Secondary Outcome Measure Information:
Title
changing of the Constant-Murley shoulder outcome score
Description
assessment of changing in shoulder range of motion, pain and strength
Time Frame
baseline (T0), five weeks (T1), three months (T2), six months (T3)
Title
changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score
Description
Assessment of changing of the physical ability on daily-living tasks
Time Frame
baseline (T0), five weeks (T1), three months (T2), six months (T3)
Title
changing of the visual analogic scale (VAS)
Description
assessment of changing of shoulder Pain at rest
Time Frame
baseline (T0), five weeks (T1), three months (T2), six months (T3)
Title
changing of the visual analogic scale (VAS)
Description
assessment of changing of shoulder Pain during movements
Time Frame
baseline (T0), five weeks (T1), three months (T2), six months (T3)
Title
changing of the Likert score
Description
assessment of changing in participant satisfaction
Time Frame
baseline (T0), five weeks (T1), three months (T2), six months (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital "A. Gemelli", Catholic University of the Sacred Heart
City
Rome
Country
Italy

12. IPD Sharing Statement

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

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