NCT02478567

Brief Summary

Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

June 16, 2015

Last Update Submit

May 14, 2016

Conditions

Outcome Measures

Primary Outcomes (4)

  • American Shoulder Elbow Surgeon's Outcome Score

    self-report of function

    16 weeks

  • Numeric Pain Score

    pain levels

    16 weeks

  • Global Rating of Change

    patient satisfaction

    16 weeks

  • Global Percentage of Improvement

    patient perception of status

    16 weeks

Study Arms (2)

Scapular Training

EXPERIMENTAL

Initiated scapular training exercise for the first 4 weeks followed by addition of rotator cuff exercises the next four weeks

Other: Scapular Training

Rotator Cuff Training

EXPERIMENTAL

initiated rotator cuff training exercise for the first 4 weeks followed by addition of scapular training exercises the next four weeks.

Other: Rotator Cuff Training

Interventions

four specific band-resisted strength training exercises for scapula

Also known as: exercise
Rotator Cuff Training

four specific band-resisted strength training exercises for rotator cuff

Also known as: exercise
Scapular Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm
  • presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation.

You may not qualify if:

  • concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis -
  • osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale
  • current diagnosis and/or previous history of glenohumeral instability or dislocation
  • full-thickness rotator cuff tear
  • adhesive capsulitis
  • fractures of the scapula, clavicle or humerus
  • scapulothoracic or rotator cuff paresis
  • shoulder surgery in past year
  • inability to speak the English language at a level sufficient to obtain informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 76039, United States

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 23, 2015

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

January 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations