Clinical trial NCT01785745: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: conservative treatment
shoulder
neurocognitive therapeutic exercise
traditional therapeutic exercise
pain
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
Secondary outcomes:
measure: changing of the Constant-Murley shoulder outcome score
timeFrame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
measure: changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score
timeFrame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
measure: changing of the visual analogic scale (VAS)
timeFrame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
measure: changing of the visual analogic scale (VAS)
timeFrame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
measure: changing of the Likert score
timeFrame: baseline (T0), five weeks (T1), three months (T2), six months (T3)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Hospital "A. Gemelli", Catholic University of the Sacred Heart
Study officials:
References: