Lumbar Spinal Stenosis Clinical Trial
Official title:
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis
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.
BACKGROUND: Lumbar spinal stenosis (LSS) is a condition that is highly prevalent in the
senior citizen population. LSS is the most frequent indication for spinal surgery in patients
over the age of 65 years. The fastest growth in lumbar surgery in the U.S. this past decade
has occurred in older adults with LSS and the rate of complex fusion procedures has increased
15-fold. These surgical procedures are associated with significant health care costs, risks,
complications, and re-hospitalization rates. Yet, evidence is lacking for the effectiveness
of the various non-surgical treatments offered to patients with LSS. This knowledge gap has
greatly hindered the development of clinical practice guidelines relevant to the non-surgical
treatment approaches for LSS.
OBJECTIVES: This study will perform a comparison of three common approaches to the
non-surgical management and treatment of patients with LSS. The specific research questions
associated with this study are: (1) How do group exercise and manual therapy with
rehabilitative exercise compare with medical care? (2) How do group exercise and manual
therapy with rehabilitative exercise compare with each other? (3) Are there any baseline
predictors associated with clinical improvement in any of these non-surgical treatment
approaches? The long term objective of this study is to produce research evidence relevant to
community stakeholders and to inform better decision making about non-surgical treatment
options available to LSS patients.
METHODS: This will be a comparative effectiveness study utilizing the research design of a
randomized controlled clinical trial (RCT). It will be a 3-group RCT that allows for
pragmatic treatment approaches in each of the three study arms. The study sample will consist
of 259 older adults (>60 years) who have symptoms consistent with a diagnosis of LSS, which
will be confirmed by clinical examination and diagnostic imaging. Eligible subjects will be
randomized into one of three pragmatic treatment approaches: 1) medical care; 2) group
exercise; or 3) manual therapy with rehabilitative exercise.
All subjects will be treated for a 6-week course of care. Primary outcome measures are two
validated research measurement tools; the Swiss Spinal Stenosis Questionnaire (self-reported
pain/function) and the Self Paced Walking Test (performance-based measure). We will also
employ a novel secondary outcome measure; the Sense Wear Armband which provides a real-time
measure of physical activity during normal daily living.
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