Improving Function in Elders With Chronic Lower Back Pain
What is the study about?
The "Improving Function in Older Adults with Chronic Low Back Pain" project is a research study at the University of Delaware within the
Physical Therapy Department that is funded by the National Institutes of Health. The aim of this study is to evaluate the
effectiveness of two different interventions for chronic low back pain and the impact of pain on: - self-reported disability
- physical function
- psychosocial function
- trunk muscle composition and function
Who can participate?
In order to be included in the study you must meet the following requirements:
1. be between the ages of 60-85
2. have pain in the lower back for at least 3 months which occurs every day or almost every day
3. be able to walk community distances, with or without a cane
4. be able to complete phone interviews and self-report forms
Additionally, you may NOT be able to participate in the following cases:
1. past medical history of extensive spinal surgery
2. you have a pacemaker
3. you have experienced recent trauma which limits your ability to participate fully
4. acute or terminal illness, which limits your ability to participate in weekly sessions
5. pain anywhere in the body that is greater than the pain in your lower back
6. pain below the knee related to your back pain
7. you have severe vision or hearing impairments
8. other established problems in your back, including fractures, ankylosing spondylitis, etc.
You will NOT be
excluded due to arthritis of the back.
How do I become a participant?
Contact Martha Callahan, research coordinator, at (302) 831-6202, at the University of Delaware Physical Therapy Department to complete a phone interview, which is part of an initial screen to ensure you meet the above requirements of the study. If you pass this screen, you will be given a detailed explanation of the study, after which you will be invited to schedule an evaluation. Any questions you may have may also be answered at this time. If you elect to partake in the study, the phone interviewer will ask for your name, address, etc. The research team will contact your doctor for medical clearance for your participation in the study. Before your scheduled evaluation, you will receive a mailing packet with study information, directions, and forms for you to complete, which ask about your general health, current medications, mood, and limitations in your everyday life. It is requested that you complete all forms prior to your scheduled physical therapy evaluation.
What will it be like if I am accepted into the study?
You will be evaluated by a licensed physical therapist upon entry into the study, at conclusion of the intervention (12 weeks), and at 6
months to determine lasting effects. You will be contacted by phone at 4 and 5 months after entering the study to discuss your status. The
evaluations will include a standardized physical therapy evaluation at the University of Delaware Physical Therapy Clinic, which will test
your physical performance, assess your ability to perform everyday tasks, and look at the way you walk. Subjects will also receive
rehabilitative ultrasound assessment of muscles of the trunk and low back regions, similar to that used during pregnancy. Subjects will be
requested to get an MRI at the Abby Medical Center upon entry into the study and at 12 weeks after his/her initial evaluation. MRI or
Magnetic Resonance Imaging, is a form of medical imaging used to see different structures within the body. It will enable us to assess if
your physical therapy treatment increased the size of your trunk muscles or improved your muscle make-up.
After your evaluation as discussed above, you will begin your treatments. You will be placed in one of two treatment groups for low back
pain. You will receive physical therapy interventions 2 times per week for 12 weeks. Sessions will last 45-60 minutes each time and be
administered by a licensed physical therapist. You will be asked to complete a home program daily.
Will the study cost me money?
There is no out-of-pocket cost for you to participate in this study. After completion of the 12 week therapy program and follow-up
evaluation, you will receive an honorarium of $100. An additional $50 will be given after your 6 month follow-up.
Who can I contact for more information?
If you have any questions regarding this study, please contact Martha Callahan at (302) 831-6202, or by email at mcall@udel.edu.
