MedDataX Logo

Effects of Overload Progressive in the Treatment of Shoulder

NCT ID: NCT02870257

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Impingement Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progressive overload strengthening group

Strengthening protocol with progressive load

Strengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions)

Group Type EXPERIMENTAL

Strengthening protocol with progressive load

Intervention Type OTHER

Strengthening protocol for scapular and shoulder muscles

Strengthening group

Strengthening protocol without progressive load

Strengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions)

Group Type ACTIVE_COMPARATOR

Strengthening protocol without progressive load

Intervention Type OTHER

Strengthening protocol for scapular and shoulder muscles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Strengthening protocol with progressive load

Strengthening protocol for scapular and shoulder muscles

Intervention Type OTHER

Strengthening protocol without progressive load

Strengthening protocol for scapular and shoulder muscles

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

André Serra Bley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

André S Bley, Msd

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UNINOVE

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1.487.198

Identifier Type: -

Identifier Source: org_study_id