Effects of Overload Progressive in the Treatment of Shoulder

Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Other: Strengthening protocol with progressive load; Other: Strengthening protocol without progressive load

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01504001
      • UniNove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Strengthening protocol with progressive load; Strengthening protocol for scapular and shoulder muscles
Active Comparator: 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)	Other: Strengthening protocol without progressive load; Strengthening protocol for scapular and shoulder muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Numeric pain rating scale (0-10)	baseline, 10 weeks, 3 months and 6 months
Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)	baseline, 10 weeks, 3 months and 6 months
Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)	baseline, 10 weeks, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities	DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire (0-100)	Change from baseline at 10 weeks
Quality of life	WORC (The Western Ontario Rotator Cuff Index) Questionnaire (0-100)	Change from baseline at 10 weeks
Muscle Strength	Shoulder internal rotation, external rotation, adduction and abduction muscles measured by handheld dynamometer	Change from baseline at 10 weeks
Scapular kinematic	3D data of scapula at 30, 60, 90 and 120° of shoulder abduction	Change from baseline at 10 weeks
Global impression of recovery	GPE (global perceived effect) scale (-5 to +5)	Change from baseline at 10 weeks, 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: André S Bley, Msd, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Syndrome; Shoulder Impingement Syndrome
• Other Study ID Numbers: 1.487.198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED