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Physical Therapy Program for Prevention of Shoulder Pain After Device Implant

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ClinicalTrials.gov Identifier: NCT00680537
Recruitment Status : Unknown
Verified April 2008 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : May 20, 2008
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Procedure: Exercises Not Applicable

Detailed Description:

One hundred patients who undergo subcutaneous ICD or pacemaker implant and consent to inclusion in the trial will be randomized to one of two groups. One group will receive standard of care instructions after implant. These standard instructions include: no pushing or pulling movements with arm on side of implant, no lifting over 5 lbs., and no movements above the level of the shoulder for six weeks post implant. This will be the control group. The second group, the exercise group, will be instructed verbally on a series of specific exercises (appendix A) to be completed at least three days per week for 6 weeks.

After the patient signs informed consent, a demographic form will be completed. At this enrollment visit, both groups will be asked to use a visual analog scale to report level of shoulder and/or extremity discomfort. Physical exam will include the impingement test, assessment of shoulder elevation, and measurement of the angle of abduction at which discomfort occurs. Subjects will be given the QuickDASH questionnaire (Appendix B) to complete. This questionnaire is an 11 item self-report questionnaire designed to assess the physical function and symptoms during certain activities.

At the 1 week follow-up visit, the patient will be informed of their randomization group. The patients in the control group will receive standard of care instructions. The patients in the exercise group will have specific exercises demonstrated to them and written instructions with pictures will be provided for home reference. Follow-up for both groups will occur at 1, 3 and 6 months post implant and it will include a physical exam, the QuickDASH questionnaire, and the visual analog scale. Patients in the exercise group will be asked to complete an exercise log and return it to the study staff after the 6 week of exercise is complete. In addition, telephone follow-ups will be completed for the exercise group at 2, 3, 5, and 6 weeks post implant. Patients will be asked how often they complete the exercises.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Therapy Program for Prevention of Shoulder Pain After Device Implant
Study Start Date : April 2008
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Control group
Experimental: 2
Exercise group
Procedure: Exercises
Completion of a series of shoulder exercises for 6 weeks post device implant



Primary Outcome Measures :
  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. [ Time Frame: 6 mo ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects undergoing ICD or pacemaker device implant

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680537


Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Carol Nguyen    214-590-5015    Carol.Nguyen@UTSouthwestern.edu   
Principal Investigator: Jose A Joglar         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jose A Joglar UT Southwestern Medical Center

Responsible Party: Jose Joglar, MD, UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00680537     History of Changes
Other Study ID Numbers: UTSW IRB # 082006-080
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: April 2008

Keywords provided by University of Texas Southwestern Medical Center:
physical therapy program

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms