Exercise Training Sequence for Subacromial Impingement Sy... | NCT02478567

Studies
Exercise Training Sequence for Subacromial Impingement Syndrome

NCT02478567

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Subacromial Impingement Syndrome

Interventions

Rotator Cuff Training
Scapular Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 17, 2015

First Posted Date

Jun 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2016

Last Update Posted Date

May 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ed Mulligan, Associate Professor, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

While physical therapy is an effective element in the rehabilitation of rotator cuff (RC) disease, the most effective sequence of training interventions has not been defined. The purpose of this study is to determine if there is a difference in pain or function in patients who are given RC strengthening prior to or after initiating scapular stabilization exercises.

The study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular stabilization exercises while the other group began with RC strengthening exercises. The crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rotator Cuff Training	Other	four specific band-resisted strength training exercises for scapula	Rotator Cuff Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-80 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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern Medical Center		Dallas	Texas	76039	United States

Condition Browse Module

MeSH Terms

ID	Term
D019534	Shoulder Impingement Syndrome

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070599	Shoulder Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided