Clinical trial NCT02870257: Effects of Overload Progressive in the Treatment of Shoulder
Official title: Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 sessions).


Eligibility criteria: Inclusion Criteria:

* People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis
* shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS
* at least 130° shoulder active elevation
* 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy
* positive dynamic scapular dyskinesis in clinical observation

Exclusion Criteria:

* Referred pain from vertebral spine
* previous shoulder, elbow or neck surgery
* complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)
* neoplastic or neurological disorders
* previous fracture or dislocation injury (shoulder, humerus, clavicle)
* adhesive capsulitis signs
* inflammatory diseases
* specific treatment for the shoulder in the previous four months (injection, physiotherapy)
* using drugs in the previous week
* inability to understand portuguese language

Primary outcomes:
measure: Change in Numeric pain rating scale (0-10)
timeFrame: baseline, 10 weeks, 3 months and 6 months
measure: Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)
timeFrame: baseline, 10 weeks, 3 months and 6 months
measure: Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)
timeFrame: baseline, 10 weeks, 3 months and 6 months
Secondary outcomes:
measure: Disabilities
timeFrame: Change from baseline at 10 weeks
measure: Quality of life
timeFrame: Change from baseline at 10 weeks
measure: Muscle Strength
timeFrame: Change from baseline at 10 weeks
measure: Scapular kinematic
timeFrame: Change from baseline at 10 weeks
measure: Global impression of recovery
timeFrame: Change from baseline at 10 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: UNINOVE
state: SP
Study officials:
affiliation: University of Nove de Julho
name: André S Bley, Msd
role: PRINCIPAL_INVESTIGATOR
References: