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Effects of Overload Progressive in the Treatment of Shoulder

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strengthening protocol with progressive load
Strengthening protocol without progressive load
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNINOVE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive overload strengthening group

Strengthening group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Numeric pain rating scale (0-10)
Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)
Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2016
Last Updated
October 9, 2017
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02870257
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive overload strengthening group
Arm Type
Experimental
Arm Description
Strengthening protocol with progressive load Strengthening muscle exercises for the shoulder and scapular with progressive increase of load during 10 weeks (20 sessions)
Arm Title
Strengthening group
Arm Type
Active Comparator
Arm Description
Strengthening protocol without progressive load Strengthening muscle exercises for the shoulder and scapular without increase of load (minimal load) during 10 weeks (20 sessions)
Intervention Type
Other
Intervention Name(s)
Strengthening protocol with progressive load
Intervention Description
Strengthening protocol for scapular and shoulder muscles
Intervention Type
Other
Intervention Name(s)
Strengthening protocol without progressive load
Intervention Description
Strengthening protocol for scapular and shoulder muscles
Primary Outcome Measure Information:
Title
Change in Numeric pain rating scale (0-10)
Time Frame
baseline, 10 weeks, 3 months and 6 months
Title
Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)
Time Frame
baseline, 10 weeks, 3 months and 6 months
Title
Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)
Time Frame
baseline, 10 weeks, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Disabilities
Description
DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire (0-100)
Time Frame
Change from baseline at 10 weeks
Title
Quality of life
Description
WORC (The Western Ontario Rotator Cuff Index) Questionnaire (0-100)
Time Frame
Change from baseline at 10 weeks
Title
Muscle Strength
Description
Shoulder internal rotation, external rotation, adduction and abduction muscles measured by handheld dynamometer
Time Frame
Change from baseline at 10 weeks
Title
Scapular kinematic
Description
3D data of scapula at 30, 60, 90 and 120° of shoulder abduction
Time Frame
Change from baseline at 10 weeks
Title
Global impression of recovery
Description
GPE (global perceived effect) scale (-5 to +5)
Time Frame
Change from baseline at 10 weeks, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André S Bley, Msd
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNINOVE
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01504001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Overload Progressive in the Treatment of Shoulder

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