Physical Therapy Program for Prevention of Shoulder Pain After Device Implant
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/11/2019 |
| Start Date: | April 2008 |
| End Date: | April 2011 |
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.
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.
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.
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.
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.
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