Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Status:
Completed
Trial end date:
2016-06-10
Target enrollment:
Participant gender:
Summary
BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a
condition that is very common; found in about 30% of older adults. It is the most common
reason for people over the age of 65 to have back surgery. Some patients with stenosis do not
need back surgery and can be treated with other methods, such as physical therapy,
chiropractic, exercise, and medication. But we just don't have enough good research to tell
us which treatment works best for which patient and under which circumstances. This research
study hopes to provide more information about the effectiveness of the various non-surgical
choices for managing stenosis.
OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical
treatment approaches for stenosis:
1. Medical care that involves prescription medications and/or spinal injections (epidurals)
2. Group exercise in supervised classes given in a community center setting
3. Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by
physical therapists and chiropractors
METHODS: This research study will involve 259 adults who are at least 60 years old and have
been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into
three groups, each group receiving one of the 3 types of treatments listed above under
"Objectives". The determination of which type of treatment each person receives will be
determined by chance, using a computerized version of flipping a coin. This is a process
known as randomization, which scientists think reduces the bias in research studies. A series
of tests and questionnaires will be given to the patients before and after they get treatment
and comparisons will be made to see how much improvement they made with each of the types of
treatments. Finally, the researchers will compare the differences between the 3 treatment
groups to see if certain types of treatment produced better results than others, and if there
were any examination findings that could be used to predict which type of patient would do
better with which type of treatment.
Phase:
N/A
Details
Lead Sponsor:
Michael Schneider, DC, PhD University of Pittsburgh