NCT00632996

Brief Summary

The purposes of this study are to:

  1. 1.determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome;
  2. 2.determine which patients are likely to respond to this rehabilitation program and which patients are not likely to respond to this rehabilitation program
  3. 3.the rehabilitation treatment program will result in significant changes in pain and quality of life
  4. 4.there will be items from the history and examination that will identify those patients who respond favorably and those who do not respond favorably to rehabilitation at 6 weeks, 3, 6 and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

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

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

6 years

First QC Date

March 3, 2008

Last Update Submit

December 18, 2015

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder painshoulder impingement syndromemanual therapyrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Shoulder disability

    6 week and 3, 6, 12 months

Secondary Outcomes (5)

  • Patient satisfaction

    6 weeks and 3, 6, 12 months

  • Quality of life

    6 weeks and 3, 6, 12 months

  • Pain with rest, normal activities, and strenuous activities

    6 weeks and 3, 6, 12 months

  • Patient perceived global rating of effect

    6 weeks and 3 months

  • Additional healthcare utilization and medication use

    6 weeks and 3, 6, 12 months

Study Arms (1)

1

EXPERIMENTAL
Other: Rehabilitation

Interventions

RehabilitationOTHER

Exercise, manual therapy, patient education, posture, home exercise program

Also known as: Physical Therapy, Manual Therapy
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of shoulder impingement syndrome as evidence by all 5 criteria:
  • Reproduction of symptoms with impingement test: either Hawkins-Kennedy or Neer Test
  • Pain during active shoulder elevation at or above 60 degrees
  • Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
  • Shoulder disability: greater than or equal to 20/100 (0 = no disability)
  • Able to understand written and spoken English

You may not qualify if:

  • Severe pain; pain is \> or equal to 7/10 on NPRS (0 = no pain)
  • Shoulder surgery on affected shoulder
  • Traumatic shoulder dislocation within the past 3 months
  • Previous rehabilitation for this episode of shoulder pain
  • Reproduction of shoulder pain with active or passive cervical motion
  • Systemic inflammatory joint disease
  • Global loss of passive shoulder ROM, indicative of adhesive capsulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.

    PMID: 20710088DERIVED

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Interventions

RehabilitationPhysical Therapy ModalitiesMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesComplementary Therapies

Study Officials

  • Lori A Michener, PhD, PT, ATC

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

  • Phillip W McClure, PhD, PT

    Arcadia University

    PRINCIPAL INVESTIGATOR

  • Angela R Tate, PhD, PT

    Arcadia University

    STUDY DIRECTOR

  • Ian A Young, PT

    Virginia Commonwealth University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 11, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 21, 2015

Record last verified: 2015-12

Locations

US(1)