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

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ClinicalTrials.gov Identifier: NCT01785745
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Carlo Bertolini, 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.

Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Other: Neurocognitive therapeutic exercise Other: Traditional therapeutic exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 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 :
  1. changing of the Constant-Murley shoulder outcome score [ Time Frame: baseline (T0), five weeks (T1), three months (T2), six months (T3) ]
    assessment of changing in shoulder range of motion, pain and strength

  2. changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score [ Time Frame: baseline (T0), five weeks (T1), three months (T2), six months (T3) ]
    Assessment of changing of the physical ability on daily-living tasks

  3. changing of the visual analogic scale (VAS) [ Time Frame: baseline (T0), five weeks (T1), three months (T2), six months (T3) ]
    assessment of changing of shoulder Pain at rest

  4. changing of the visual analogic scale (VAS) [ Time Frame: baseline (T0), five weeks (T1), three months (T2), six months (T3) ]
    assessment of changing of shoulder Pain during movements

  5. changing of the Likert score [ Time Frame: baseline (T0), five weeks (T1), three months (T2), six months (T3) ]
    assessment of changing in participant satisfaction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785745


Locations
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Italy
University Hospital "A. Gemelli", Catholic University of the Sacred Heart
Rome, Italy
Sponsors and Collaborators
Catholic University of the Sacred Heart

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Responsible Party: Carlo Bertolini, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01785745     History of Changes
Other Study ID Numbers: 486/2012
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Carlo Bertolini, Catholic University of the Sacred Heart:
conservative treatment
shoulder
neurocognitive therapeutic exercise
traditional therapeutic exercise
pain
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases