NCT02153827

Brief Summary

The purpose of this study is to examine the effects of eccentric exercise to the shoulder muscles for people with shoulder pain. Identifying specific exercise protocols for individuals with shoulder pain will provide evidence to help clinicians select the best interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

March 31, 2014

Results QC Date

April 28, 2016

Last Update Submit

August 26, 2016

Conditions

Subacromial Impingement Syndrome

Keywords

ShoulderEccentric TrainingSubacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Western Ontario Rotator Cuff Index

    shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.

    6 months

Secondary Outcomes (4)

  • Global Rating of Change

    6 months

  • Numeric Pain Rating Scale

    6 months

  • Shoulder Active Range of Motion

    6 months

  • Upper Quarter Y Balance Test

    6 months

Study Arms (2)

Eccentric External rotator training

EXPERIMENTAL

Eccentric Shoulder External Rotators along with scapular retraction and posterior shoulder stretching exercises.

Other: Eccentric Shoulder External Rotator Training

General shoulder exercise

SHAM COMPARATOR

General shoulder exercise protocol of active flexion, abduction, scapular retraction and posterior shoulder stretching exercises.

Other: General Shoulder exercise

Interventions

Eccentric Shoulder External Rotator TrainingOTHER

Eccentric training exercise for the external rotators, 3 sets of 15 daily.

Eccentric External rotator training
General Shoulder exerciseOTHER

general exercise consisting of active shoulder movements

General shoulder exercise

Eligibility Criteria

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

You may qualify if:

  • Presence of non-acute shoulder pain (greater than 3 months duration)
  • out of the 6 following tests positive, Neer impingement, Hawkins-Kennedy impingement, empty can test, resisted external rotation test, palpable tenderness at the insertion of the supraspinatus or infraspinatus, and painful arc from 60° to 120° during active abduction.
  • Age over 18 years old
  • Sufficient ability to read English as required for completing questionnaires

You may not qualify if:

  • Red flags noted in the patient's Medical Screening Questionnaire (MSQ) (ie. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use)
  • Full thickness supraspinatus or infraspinatus tendon tear as determined by a positive drop arm test, lag sign or rent test.
  • Shoulder adhesive capsulitis as evidenced by a limitation in passive motion for all shoulder planes of movement.
  • Having an upper extremity amputation.
  • Individuals having a history of surgery to the cervical spine or involved upper extremity for a musculoskeletal, neurological or dermatological condition for which they are at the time of data collection receiving post-operative care.
  • Pending legal action regarding their shoulder pain
  • Inability to comply with treatment and follow up schedule
  • Insufficient English language skills to complete all questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of St. Augustine

Saint Augustine, Florida, 32086, United States

Location

Related Publications (5)

  • Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.

    PMID: 22349588RESULT

  • Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.

    PMID: 22441232RESULT

  • Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.

    PMID: 22581193RESULT

  • Bernhardsson S, Klintberg IH, Wendt GK. Evaluation of an exercise concept focusing on eccentric strength training of the rotator cuff for patients with subacromial impingement syndrome. Clin Rehabil. 2011 Jan;25(1):69-78. doi: 10.1177/0269215510376005. Epub 2010 Aug 16.

    PMID: 20713438RESULT

  • Jonsson P, Wahlstrom P, Ohberg L, Alfredson H. Eccentric training in chronic painful impingement syndrome of the shoulder: results of a pilot study. Knee Surg Sports Traumatol Arthrosc. 2006 Jan;14(1):76-81. doi: 10.1007/s00167-004-0611-8. Epub 2005 May 5.

    PMID: 15877219RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Results Point of Contact

Title
Eric Chaconas
Organization
University of St. Augustine
echaconas@usa.edu
904-826-0084

Study Officials

  • Morey Kolber, PhD, PT

    Nova Southeastern

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

June 3, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 20, 2016

Results First Posted

October 20, 2016

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)