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Completed

NCT Number: NCT01785745

Study of Neurocognitive Therapeutic Exercise in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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