NCT00680537

Brief Summary

This is a clinical research study to determine if a prescribed physical therapy intervention after subcutaneous implantation of an implanted cardioverter-defibrillator (ICD) or pacemaker reduces the incidence of rotator cuff tendonitis when compared to usual post procedural care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

May 15, 2008

Last Update Submit

January 7, 2019

Conditions

Shoulder Pain

Keywords

physical therapy program

Outcome Measures

Primary Outcomes (1)

  • to determine if a prescribed physical therapy intervention after subcutaneous implantation of an implanted cardioverter-defibrillator (ICD) or pacemaker reduces the incidence of rotator cuff tendonitis when compared to usual post procedural care.

    6 mo

Study Arms (2)

1

NO INTERVENTION

Control group

2

EXPERIMENTAL

Exercise group

Procedure: Exercises

Interventions

ExercisesPROCEDURE

Completion of a series of shoulder exercises for 6 weeks post device implant

2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing ICD or pacemaker device implant

You may not qualify if:

  • Prior shoulder injury or surgery
  • Mastectomy on affected side
  • CVA with ipsilateral arm involvement
  • Inability or refusal to perform exercises as prescribed.
  • Subjects who would not be able to come in for follow-up visits at one, three, and six-month intervals will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jose A Joglar

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 20, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2011

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

US(1)