Degenerative Lumbar Spinal Stenosis Clinical Trial
Official title:
Self-Management to Improve Walking Ability in Degenerative Lumbar Spinal Stenosis: the Evaluation of Four Novel Strategies.
Arthritis of the spine causes narrowing of the spinal canals and compression of the spinal nerves traveling into the legs, limiting walking ability. The vast majority of individuals with arthritis of the spine are not suited for surgery and most receive non-surgical treatment. However, we do not know what non-surgical treatments are effective in improving walking in these people. The purpose of our research is to test four new treatments for arthritis of the spine to see if they can improve walking ability. Each treatment approach focuses on the changes that occur in the spine and the whole person as a result of the arthritis that directly or indirectly impacts the ability to walk and perform usual daily activities. Because arthritis of the spine is a chronic condition usually does not go away, it is important that people acquire the knowledge, skills, and tools to manage their condition on their own. The treatments that investigators plan to test as part of this research proposal are aimed at achieving this goal. However, before the investigators can promote the use of these treatments they need to formally test them using strict scientific methods to make sure they do more good than harm. The four treatments include 1) a six week training program referred to as "Boot Camp for Stenosis" which provides one-on-one training on exercise and self-management strategies 2) a patient educational workbook and video on how to self-manage, 3) an electrical device that is placed on the lower back to reduce nerve pain when walking and 4) a spinal stenosis belt that people can wear to reduce pressure on the nerves while walking. The plan is to assess the change in walking distance using the various treatments and assess what impact the treatments have on peoples' overall function and quality of life. Innovative treatment approaches with a long term perspective are urgently needed to deal with the growing number of people with arthritis of the spine who are disabled. It is likely that there is not one solution to this problem - many people will require more than one type of treatment, but an important first step is to determine which treatments are effective, then tailor the treatments to the needs of each person.
Degenerative lumbar spinal stenosis (DLSS) or osteoarthritis of the spine is a leading cause
of pain, disability, and loss of independence in older adults. It is a chronic disease caused
by age related degenerative narrowing (stenosis) of the spinal canal that can lead to
compression and ischemia of the spinal nerves (neuro-ischemia). The clinical syndrome of DLSS
is known as neurogenic claudication. It is characterized by bilateral or unilateral buttock
and/or lower extremity pain, heaviness, numbness, tingling or weakness, precipitated by
walking and standing and relieved by sitting and bending forward. Limited walking ability is
the dominant functional impairment caused by DLSS. Those afflicted have greater walking
limitations than individuals with knee or hip osteoarthritis and greater functional
limitations than those with congestive heart failure, chronic obstructive lung disease or
systemic lupus erythematosus. Inability to walk among individuals with DLSS leads to a
sedentary lifestyle and a progressive decline in health status. The prevalence and economic
burden of DLSS is growing exponentially due to the aging population. Although DLSS is the
most common reason for spine surgery in individuals over the age of 65, only very few DLSS
patients receive surgery. The vast majority of individuals with DLSS receive non-surgical
care. However, what constitutes effective non-surgical care is unknown. Self-management
strategies may be a practical and effective means to improve walking ability, functional
status, and quality of life in this chronic arthritic and often progressive condition. The
investigators have conducted two systematic reviews of the literature, one assessing the
effectiveness of non-surgical treatments for neurogenic claudication which included
randomized controlled trials (RCTs) assessing improvements in pain, disability, quality of
life or global improvement; the other evaluated the effectiveness of surgical or non-surgical
interventions and included only RCTs that assessed improved walking ability. the
investigators learned from these reviews that the evidence for interventions that improve
outcomes including walking ability in neurogenic claudication due to DLSS is lacking. The
evidence published thus far on this topic has been of low or of very low quality, prohibiting
the formulation of evidence-based recommendations for clinical practice. Moreover, the
investigators identified no RCTs that examined a self-management approach to the treatment of
DLSS.
In addition to the structural arthritic changes causing narrowing of the spinal canal, DLSS
has an important dynamic component. The volume of the spinal canal and degree of epidural
pressure and ischemia of the spinal nerves can change depending on spinal posture. Both
lumbar flexion (stooping forward), and sitting increase the diameter of the canal and reduce
spinal nerve ischemia, and correspond with a reduction or elimination of lower extremity
symptoms. Conversely, lumbar extension or increasing the lumbar lordosis (which occurs when
standing) reduces the diameter of the spinal canal and increases spinal nerve ischemia, and
corresponds with increased lower extremity symptoms. The ability to reduce symptoms of DLSS
by changing spinal posture/structural alignment and/or increasing blood flow to the spinal
nerve provides potential mechanisms for developing interventions to improve symptoms and
walking ability.
First, the investigators have designed and implemented a novel six week self-management
training program for DLSS over the past 3 years at the Spinal Stenosis Clinic at the Rebecca
MacDonald Centre for Arthritis and Auto-immune Diseases at Mount Sinai Hospital (MSH). The
goal of the training program is to provide patients with the knowledge, skills,
self-confidence, and physical capacity to manage their symptoms and maximize their function.
The program is multi-modal, tailored and directed to the structural, functional,
physiological and psychosocial consequences of DLSS. Particular emphasis is placed on
exercise instruction to build core and lower extremity strength and enable individuals to
achieve optimal posture during standing and walking.
There are numerous human studies demonstrating significant reduction in laboratory induced
ischemic pain in the lower and upper extremities with paraspinal TENS compared to placebo
TENS. Moreover, there is low quality evidence from one case series suggesting that electrical
stimulation may be effective for the management of neurogenic claudication. Higher quality
studies are needed to assess whether paraspinal TENS applied while walking improves walking
ability, as this could be an innovative, convenient, and inexpensive self-management strategy
for DLSS patients.
Finally, the investigators have designed a prototype spinal stenosis belt with the Ontario
College of Art and Design. The belt is designed as garment that will snugly fit over the
sacrum and pelvic girdle with a pump that place pressure over the sacrum with the aim to
reduce the lumbar lordosis and maximize the spinal canal diameter when walking. The
investigators hypothesize the belt will reduce the lumbar lordosis and alleviate epidural
pressure and neuro-ischemia while standing and walking. The investigators identified two
preliminary studies evaluating back belts, supports or braces for DLSS, none of which were
RCTs. These studies found significant improvements in walking distance with the use of a back
corset; however both studies had a high risk of bias.
OBJECTIVES AND HYPOTHESES The overall goal of this study is to assess the effectiveness of
four self-management strategies in improving walking ability among patients with DLSS. The
investigators primary objective is to compare the effectiveness of a comprehensive six week
self-management training program that includes a patient instructional workbook, video and
pedometer to a patient workbook, video and pedometer alone. The investigators secondary
objectives are: 1) to compare the change in walking capacity from baseline when using
superficially applied para-spinal TENS versus placebo para-spinal TENS applied during walking
and 2) to compare the change in walking capacity from baseline while wearing a novel spinal
stenosis belt to the use of a sham spinal stenosis belt while walking. The investigators
hypothesize that the self-management training program with workbook, video and pedometer will
be more effective in improving walking capacity and functional outcomes than the use of a
workbook, video and pedometer alone. Furthermore, the investigators hypothesize that
para-spinal TENS or the novel spinal stenosis belt used while walking will be more effective
in improving walking capacity than placebo TENS or a sham spinal stenosis belt, respectively.
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