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>> The JAMA Network.
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>> Hello, I'm Dr. Harley Goldberg,
the Director of the Spine Care Program
at Kaiser Permanente, Northern California.
We, of course, have a lot of patients
with spine problems including
herniated discs and acute radiculopathy.
And over the years we have moved, as many have,
from the surgical treatment to
the interventional treatment.
And it has been my observation clinically that
people would get better with oral Prednisone
as well as, perhaps, epidural
steroid injections.
So because of that we underwent the randomized
double blind clinical trial of oral Prednisone
versus placebo for acute radiculopathy
associated with a herniated lumbar disc.
We randomized nearly 300 patients.
It was 269 patients that were adult patients
enrolled in the Kaiser Permanente Program,
who presented with clinical acute radiculopathy
and who were found also to be confirmed
with a positive MRI that matched
clinically their clinical presentation.
They had a physical exam and
then we used outcome instruments
that included the Oswestry Disability Index
and the Visual Analog Scale as well as subsets
of the SF36 and other global
questionnaires as well.
We studied whether or not oral Prednisone,
in a two to one randomization with placebo,
would improve pain and increase
function in this patient population.
The results were no different between the
randomized patients to placebo and those
with Prednisone in terms of pain over the
first three weeks and in fact at any point
in the time course out of 52 weeks.
We did find a statistically significant
benefit in functional improvement but it was
of minimal clinical improvement,
that is to say it was less
than seven points on a 100 point Oswestry scale.
While our dataset contains a
lot more data for us to evaluate
and determine perhaps other aspects of
noninvasive treatment of their medications
or other methods of care that may or may
not be appropriate for this population,
what was surprising to us was
that the oral Prednisone did not
in fact decrease the pain as we expected.
Our next steps will be to
evaluate how these patients rolled
over to an epidural steroid injection
to a surgical outcome and/or the use
of other concomitant pain medications
throughout the course of this study,
to let us infer what would
be the next studies needed
to find the optimal noninvasive
treatments for this population.
What this trial does not answer is
the nonspecific effects of placebo.
This trial does not have a normal treatment arm
so we do not know actually what is the
nonspecific effect of the placebo treatment?
And that is one more question
that is yet to be answered,
as in any other placebo controlled trial.
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