the Evaluation of Four Non-operative Treatments for Degenerative Lumbar Spinal Stenosis

NCT ID: NCT02592642

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-01

Brief Summary

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.

Detailed Description

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Self-management Program, Workbook, Video, Pedometer

Group Type: EXPERIMENTAL

Self-management Program, Workbook, Video, Pedometer

Intervention Type: BEHAVIORAL

Participants will attend 12 sessions over a six week period. The following therapies will be provided by licensed chiropractors: instruction on self-management strategies, cognitive behavioural techniques; exercise instruction, manual therapy. An instructional workbook and video will provide education and instruction on how to perform exercises, and reinforce instructions received during the sessions. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.

Group 2

Instructional Workbook, Video, and Pedometer

Group Type: ACTIVE_COMPARATOR

Instructional Workbook, Video, and Pedometer

Intervention Type: BEHAVIORAL

Participants will attend one session with a chiropractor at the beginning of the six week treatment period. The chiropractor will provide and explain the instructional workbook and video. The workbook and video will provide education and instruction on how to perform exercises all aimed at improving overall fitness in the back and lower extremity and facilitate lumbar flexion. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.

Group a

Para-spinal TENS

Group Type: EXPERIMENTAL

Para-spinal TENS

Intervention Type: DEVICE

Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal musculature from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine (NeuroTrac TENS from Verity Medical Ltd U.K.) which will be worn by the subject concealed within a waist pouch. The TENS will be programmed for a frequency of 65-100 Hz modulated over 3-second intervals with a pulse width of 100-200 usec, and turned on 2 minutes before the start and during the SPWT. Current intensity will be set to the level of comfort of the patient, approximately 3 milliamps in pilot experiments, and below the level causing muscle twitch.

Group b

Para-spinal Placebo TENS

Group Type: PLACEBO_COMPARATOR

Para-spinal Placebo TENS

Intervention Type: DEVICE

Group b: Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal muscular from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine \[NeuroTrac TENS from Verity Medical Ltd (U.K.)\] which will be worn by the subject concealed within a waist pouch. The TENS will be programmed using a transient placebo frequency and intensity (45) i.e. the unit will be active for the first 30 seconds then ramping down to zero stimulus over 15 seconds and worn from 2 minutes before the start and during the Self-Paced Walk Test (SPWT).

Group c

Prototype Spinal Stenosis Belt

Group Type: EXPERIMENTAL

Prototype Spinal Stenosis Belt

Intervention Type: DEVICE

Participants randomized to this subgroup will be fitted with the prototype spinal stenosis belt by a licensed chiropractor. 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 aimed at reducing lordosis.

Group d

Sham spinal stenosis belt

Group Type: SHAM_COMPARATOR

Sham Spinal Stenosis Belt

Intervention Type: DEVICE

Participants randomized to this subgroup will have a standard lumbar support belt (Tensor Adjustable Back Brace from 3M, 207744) fitted around the lumbar spine above the iliac crest comfortably according the manufacturer's instructions for wear. We speculate that the placement of the stenosis belt around the lumbar spine should not have any impact on the lumbar lordosis.

Interventions

Self-management Program, Workbook, Video, Pedometer

Participants will attend 12 sessions over a six week period. The following therapies will be provided by licensed chiropractors: instruction on self-management strategies, cognitive behavioural techniques; exercise instruction, manual therapy. An instructional workbook and video will provide education and instruction on how to perform exercises, and reinforce instructions received during the sessions. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.

Intervention Type: BEHAVIORAL

Instructional Workbook, Video, and Pedometer

Participants will attend one session with a chiropractor at the beginning of the six week treatment period. The chiropractor will provide and explain the instructional workbook and video. The workbook and video will provide education and instruction on how to perform exercises all aimed at improving overall fitness in the back and lower extremity and facilitate lumbar flexion. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.

Intervention Type: BEHAVIORAL

Para-spinal TENS

Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal musculature from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine (NeuroTrac TENS from Verity Medical Ltd U.K.) which will be worn by the subject concealed within a waist pouch. The TENS will be programmed for a frequency of 65-100 Hz modulated over 3-second intervals with a pulse width of 100-200 usec, and turned on 2 minutes before the start and during the SPWT. Current intensity will be set to the level of comfort of the patient, approximately 3 milliamps in pilot experiments, and below the level causing muscle twitch.

Intervention Type: DEVICE

Para-spinal Placebo TENS

Group b: Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal muscular from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine \[NeuroTrac TENS from Verity Medical Ltd (U.K.)\] which will be worn by the subject concealed within a waist pouch. The TENS will be programmed using a transient placebo frequency and intensity (45) i.e. the unit will be active for the first 30 seconds then ramping down to zero stimulus over 15 seconds and worn from 2 minutes before the start and during the Self-Paced Walk Test (SPWT).

Intervention Type: DEVICE

Prototype Spinal Stenosis Belt

Participants randomized to this subgroup will be fitted with the prototype spinal stenosis belt by a licensed chiropractor. 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 aimed at reducing lordosis.

Intervention Type: DEVICE

Sham Spinal Stenosis Belt

Participants randomized to this subgroup will have a standard lumbar support belt (Tensor Adjustable Back Brace from 3M, 207744) fitted around the lumbar spine above the iliac crest comfortably according the manufacturer's instructions for wear. We speculate that the placement of the stenosis belt around the lumbar spine should not have any impact on the lumbar lordosis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age greater or equal to 50 years
• Clinical symptoms of back and/or radiating lower limb or buttock pain; fatigue or loss of sensation in the lower limbs aggravated by walking and/or standing and relieved by sitting
• Intermittent or persistent pain without progressive neurological dysfunction
• Duration of symptoms and signs for more than 3 months
• Imaging confirmed spinal canal narrowing using MRI, CT scan, myelography or ultrasound
• Clinical signs and symptoms corresponding to segmental level of narrowing identified by imaging
• Patients with degenerative spondylolisthesis are included
• Not considered to be a surgical candidate (in the next 12 months) or patient unwilling to have surgery
• Able to perform mild-moderate exercise
• Able to walk without assistive devices for at least 20 metres and less than 30 minutes continuously
• Able to give written informed consent and complete interviews and questionnaires in English.

Exclusion Criteria

• Severe degenerative stenosis with intractable pain and progressive neurological dysfunction
• Lumbar spinal stenosis not caused by degeneration
• Lumbar herniated disc diagnosed during the last 12 months
• Previous back surgery for lumbar spinal stenosis or instability
• Underlying spinal disorder such as ankylosing spondylitis, neoplasm, infection or metabolic disease
• Intermittent claudication due to vascular disease
• Severe osteoarthrosis or arthritis of lower extremities causing limited walking ability
• Neurologic disease causing impaired function of the lower limbs, including diabetes
• Psychiatric disorders and /or cognitively impaired

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Arthritis Society, Canada

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Carlo Ammendolia

Associate Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Ammendolia, PhD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

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Other Identifiers

SOG-13-003

Identifier Type: -

Identifier Source: org_study_id