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
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Procedure: Exercises||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: 1
Completion of a series of shoulder exercises for 6 weeks post device implant
- 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 ]
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
|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|
|Principal Investigator:||Jose A Joglar||UT Southwestern Medical Center|