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Assistant Professor, Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, CanadaAssociate Scientist, Department of Medicine, Mount Sinai Hospital, Toronto, CanadaAssistant Professor, Department of Surgery, University of Toronto, Toronto, Canada
The purpose of this preliminary study was to assess the effectiveness of a 6-week, nonsurgical, multimodal program that addresses the multifaceted aspects of neurogenic claudication.
Methods
In this retrospective study, 2 researchers independently extracted data from the medical records from January 2010 to April 2013 of consecutive eligible patients who had completed the 6-week Boot Camp Program. The program consisted of manual therapy twice per week (eg, soft tissue and neural mobilization, chiropractic spinal manipulation, lumbar flexion-distraction, and muscle stretching), structured home-based exercises, and instruction of self-management strategies. A paired t test was used to compare differences in outcomes from baseline to 6-week follow-up. Outcomes included self-reported pain, disability, walking ability, and treatment satisfaction.
Results
A total of 49 patients were enrolled, with a mean age of 70 years. The mean difference in the Oswestry Disability Index was 15.2 (95% confidence interval [CI], 11.39-18.92), and that for the functional and symptoms scales of the Swiss Spinal Stenosis Questionnaire was 0.41 (95% CI, 0.26-0.56) and 0.74 (95% CI, 0.55-0.93), respectively. Numeric pain scores for both leg and back showed statistically significant improvements. Improvements in all outcomes were clinically important.
Conclusions
This study showed preliminary evidence for improved outcomes in patients with neurogenic claudication participating in a 6-week nonsurgical multimodal Boot Camp Program.
It is usually caused by degenerative lumbar spinal stenosis (DLSS), which refers to age-related degenerative narrowing of the spinal canals that often lead to compression and ischemia of the spinal nerves (neuroischemia).
The clinical syndrome of DLSS is known as neurogenic claudication. This syndrome is characterized by bilateral or unilateral buttock, lower extremity pain, heaviness, numbness, tingling, or weakness, precipitated by walking and standing and
The prevalence and economic burden of neurogenic claudication due to DLSS are growing exponentially due to the aging population. Although DLSS is the most common reason for spine surgery in individuals older than 65 years,
Self-management strategies may be a practical and effective means to improve walking ability, functional status, and quality of life in this chronic and often progressive condition.
The goal of self management in DLSS is to provide patients with the knowledge, skills, self-confidence, and physical capacity to manage their symptoms and maximize their function on their own.
Based on this evidence, a multimodal self-management training program was developed at our institution and is known as the Boot Camp Program for Lumbar Spinal Stenosis; however, the clinical effectiveness of this program is unknown. Therefore, the purpose of this study was to assess the effectiveness of the Boot Camp Program for Lumbar Spinal Stenosis in improving symptoms and functional status among consecutive patients with neurogenic claudication who completed the 6-week program.
Methods
A retrospective medical record review was conducted of consecutive patients who enrolled in the Boot Camp Program for Lumbar Spinal Stenosis from January 2010 to April 2013 inclusively. Medical records were selected based on the inclusion and exclusion criteria listed in Figure 1.
Figure 1Inclusion and exclusion criteria for medical record selection.
The Research Ethics Board at Mount Sinai Hospital in Toronto (MSH REB13-0058-C) gave approval for this study and exempted informed consent.
Description of Program
All patients received the following structured 6-week multimodal and self-management training program. The program consisted of one-on-one treatment sessions with one of the authors (C.A.). Each session was approximately 15 to 20 minutes in duration, and the frequency varied from 1 to 3 times per week depending on the severity of the symptoms and travel time to the clinic. The interventions were tailored and directed to the multifaceted aspects of neurogenic claudication, with an emphasis on instructing patients on self-management. The components of the Boot Camp Program for Lumbar Spinal Stenosis were as follows.
Education
Patients received instruction on self-management strategies using a cognitive behavioral approach.
Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain.
They received information on the causes of pain and disability due to DLSS, its natural history, and prognosis. They received instruction on how to manage symptoms and maintain daily routines using problem solving, pacing, relaxation, and body positioning.
Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain.
Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain.
The emphasis at each session was on maximizing function particularly walking ability. Patients were instructed on how to reduce the lumbar lordosis when standing and walking using the pelvic tilt (body repositioning techniques).
Exercises
Patients received instruction on muscle stretching, strengthening, and conditioning exercises directed at improving overall back and lower extremity fitness and facilitating lumbar flexion.
Tight muscles that promote lumbar extension were progressively stretched, and muscles that promote and control lumbar flexion were strengthened. Muscles stretching exercises included supine knee to chest and knee to opposite stretches, side posture quadriceps stretches, and standing iliopsoas stretches.
Core strengthening exercises included supine pelvic tilt and half sit ups, side posture lateral stabilizer exercises, and prone lumbar and gluteal extension exercises.
Exercise instruction was provided and reviewed at each session and was part of a progressive structured home exercise program. Patients who had limited walking ability were instructed in a graduated cycling program using a stationary forward leaning bike. A graduated walk program was implemented among patients who were not limited in their walking ability. The aim of cycle or walk program was to improve lower extremity conditioning and overall fitness and was integrated as part of the home exercise program.
Treadmill walking with body weight support is no more effective than cycling when added to an exercise program for lumbar spinal stenosis: a randomised controlled trial.
A written exercise and conditioning program schedule was provided to patients outlining the type, frequency, and intensity of the exercises to be performed. The exercises were performed twice per day at home, with the number, intensity, and frequency of each exercise increasing each week for a period of 6 weeks.
Manual Therapy
All patients received manual therapy aimed at improving the flexibility of the lumbar spine and facilitating lumbar spine intersegmental flexion. At each session, manual therapy was directed to the lumbar and thoracic spine, pelvis, and lower extremities. Specific techniques included low-amplitude high-velocity manipulation
The specific and combination of manual therapy techniques and exercises used was determined by the principal investigator (C.A.) based on identified underlying functional impairments.
A typical treatment session consisted of, first, providing education, reassurance, and positive reinforcement when improvements are noted. The patient is then positioned prone on a flexion-distraction table (Leander Model 950; Leander Healthcare Technologies, Lawrence, KS) for about 5 minutes, during which time manually assisted mechanical flexion-distraction is performed.
is used to progressively stretch the piriformis, gluteus medius, rectus femoris, adductors, and iliopsoas muscles. Side posture mobilization/manipulation
of the sciatic nerve. A review of the previous exercises is then performed followed by instruction on 2 to 3 new exercises. This routine would be repeated twice per week for 6 weeks, with the intensity and duration of the home exercises schedule increasing each week.
Data Collection, Follow-up, and Outcomes
Data were extracted from eligible patients' medical records by 2 investigators (C.A. and N.C.) independently. Baseline and 6-week follow-up data were collected. The following patient-centered outcome measures were collected:
Demographic Data and Duration of Symptoms for Both Leg and Back
Physical Function
This was measured using the physical performance scale of the Swiss Spinal Stenosis questionnaire (SSS). The SSS is a validated condition-specific measure consisting of 3 scales; a physical performance scale, a symptom severity scale, and a patient satisfaction scale.
The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis.
The physical performance scale consists of 5 questions related to walking ability. The raw scores range from 5 to 20 and mean scores from 1 to 4. Higher scores reflect lower physical performance. A change in the mean score of at least 0.1 is considered clinically important.
The mean unweighted score was calculated at baseline and at 6-week follow-up.
Symptom Severity
This was measured using the symptom severity scale of SSS. The symptom scale consists of 7 questions pertaining to overall severity of pain, pain frequency, back pain and, pain in the leg, numbness, weakness, and balance disturbance. The raw scores range from 7 to 35 and the mean scores from 1 to 5. Higher scores reflect higher symptom severity. A change in the mean score of at least 0.1 is considered clinically important.
The ODI is a reliable and validated measure of back-related disability, where 0 represents no disability and 100 represents the worse possible disability. The walking section (ODI walk) of the ODI was scored and recorded separately. The ODI walk score has been shown to be highly correlated to objective walking distance (r = 0.83).
Leg and back pain intensity while walking was independently measured at baseline and at 6-week follow-up with the 11-point numerical rating scale (NRS). The NRS is a global measure of pain intensity anchored by 2 extremes of pain intensity ranging from 0 (referring to “no pain”) to 10 (referring to “pain as bad as it could be”). Minimally clinically important difference for the NRS is estimated to be 1.5 to 2.0.
From the medical records that were selected, descriptive statistics were extracted. Improvements in outcomes were assessed by calculating the change in the mean scores from baseline to 6-week follow-up for each outcome measure. The 95% confidence interval of the mean change was calculated and a 2-sided paired t test with an α of .05 was used to assess the statistical significance of the mean change for each outcome. R Project version 3.0.1 statistical software (2009) was used for the analysis.
Data were extracted from the medical records of 49 consecutive patients who completed the Boot Camp Program for Lumbar Stenosis from January 2010 to April 2013 and completed outcome questionnaires at baseline and at the 6-week follow-up. Table 1 outlines the characteristics of the included patients. The mean age of the sample was 70 years of age, 65% were female, and the mean duration of symptoms was 11 years for back pain and 8.6 years for leg symptoms. Some medical records had missing data which accounts for the variable number of patients for the different outcomes in the analysis. The relative lower number of patients with numeric pain scores for leg or back pain also reflects the variability in symptoms where some patients have back pain but no leg pain or leg pain but no back pain. Others have no back or leg pain but had leg numbness, weakness, burning or tingling. The mean ODI was 51 and the mean walking item of the ODI was 3, suggesting that patients included in this study were severely disabled and had moderate walking limitations. The mean baseline pain score was 7 of 10 for both leg and back and SSS symptom and function scores were 3.22 and 2.27, respectively, suggesting high levels of pain and functional limitations. There were no reported adverse events.
Table 2 describes the mean difference in outcome measures after the completion of the 6-week Boot Camp Program. All outcomes demonstrated statistically significant and clinically important improvements.
Table 2Mean Difference in Outcomes From Baseline
Outcome (n)
Baseline, Mean (SD)
6-wk Posttreatment, Mean (SD)
Mean Difference (95% CI)
P
ODI (n = 45)
50.8 (13.9)
35.6 (15.6)
15.2 (11.39-18.92)
<.0001
ODI walk (n = 44)
3.39 (1.32)
2.43 (1.58)
0.96 (0.65-1.25)
<.0001
SSS symptoms (n = 44)
3.22 (0.62)
2.48 (0.60)
0.74 (0.55-0.93)
<.0001
SSS function (n = 43)
2.28 (0.43)
1.87 (0.60)
0.41 (0.26-0.56)
<.0001
NPS LBP (n = 29)
7 (2.53)
4 (2.48)
2.07 (1.05-3.09)
.0003
NPS leg (n = 25)
7 (1.79)
5 (2.70)
2.34 (1.15-3.53)
.0004
SSS treatment satisfaction (n = 43)
1.54 (0.50)
CI, confidence interval; LBP, low back pain; NPS, Numeric Pain Score; ODI, Oswestry Disability Index SSS, Swiss Spinal Stenosis Score.
This study provides preliminary evidence of the effectiveness of a self-management training program to improve symptoms and function among patients with moderate neurogenic claudication. These findings are supported by previously published guidelines
and provide the rationale to conduct future studies to test the Boot Camp Program for Lumbar Stenosis with more rigorous study designs such as a randomized controlled trial (RCT). Developing and testing novel nonsurgical approaches to improve outcomes in neurogenic claudication is important given its increasing prevalence and high morbidity.
Neurogenic claudication is a leading cause of pain, disability, and loss of independence in people older than 65 years. With the aging population, the number of people with neurogenic claudication due to DLSS is expected to rise exponentially over the next 20 years. Billions of dollars are spent each year for both surgical and non surgical treatment and these costs are increasing.
However, what constitutes effective nonsurgical treatment is unknown. A recent Cochrane Review evaluating the effectiveness of nonsurgical treatments for neurogenic claudication
identified 4 RCTs of physical therapy. The type of physical therapy used in these trials varied considerably, but one common denominator was exercise. One trial suggested that inpatient physical therapy was better than home exercise in the short term,
One trial showed short-term global improvement using a combination of manual therapy, exercise, and unweighted treadmill walking compared with flexion exercises, walking, and sham ultrasound,
Treadmill walking with body weight support is no more effective than cycling when added to an exercise program for lumbar spinal stenosis: a randomised controlled trial.
The authors of this review concluded that the overall evidence for the use of physical therapy was of low or very low quality preventing conclusion to be drawn about its effectiveness. Other systematic reviews evaluating the effectiveness of physical therapy for neurogenic claudication had similar conclusions.
A systematic review of manual therapy for spinal stenosis concluded there is preliminary evidence for potential benefit, but higher-quality evidence is needed.
This review could not identify any RCTs evaluating chiropractic treatment of lumbar spinal stenosis.
In this preliminary study, the Boot Camp Program for Lumbar Stenosis showed both statistically significant and clinically important improvements in all outcomes. The program is a tailored, structured, and comprehensive program that addresses the structural,
Dynamic change of dural sac cross-sectional area in axial loaded magnetic resonance imaging correlates with the severity of clinical symptoms in patients with lumbar spinal canal stenosis.
consequences of DLSS. Manual therapy using side posture mobilization/manipulation and flexion-distraction combined with home flexion exercises aims to improve intersegmental lumbar spine mobility. Core strengthening exercises provide the ability to self-align the spine (reducing the lumbar lordosis) while standing and walking, thereby increasing the cross-sectional area of the spinal canals and reducing nerve compression.
Stationary biking provides the opportunity to improve lower extremity strengthen and overall aerobic capacity without increasing symptoms because sitting and leaning forward increase the cross-sectional area of the spinal canals and reduce nerve compression.
Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain.
is used that combines goal setting and positive reinforcement aimed at improving functional status especially walking ability.
Neurogenic claudication due to DLSS is a chronic disease, and patients are encouraged to incorporate self-management strategies into their daily routines for life. The self-management strategies are designed to provide patients with the knowledge, skills, tools, and the physical and cognitive capabilities to maximize mobility, functional status, and quality of life.
The strengths of this study include the recruitment of consecutive patients with clinical evidence of neurogenic claudication, the use of validated outcome measures, and the large statistically significant and clinically important improvements in all outcomes. Neurogenic claudication is a clinical diagnosis, although most of included patients in this study had also imaging confirmed DLSS.
Limitations
There are several limitations to this study. This was not an experimental or prospective study. Retrospective study limitations include the difficulty to control bias and confounders and the reliance on the accuracy of the records. There was no control group or randomization, and therefore, it is uncertain whether patients would have had similar improved outcomes without the receiving the Boot Camp Program for Lumbar Stenosis. Only patients who had completed the program were included, and therefore, it is possible that patients who were not improving discharged early from the program and only patients who were improving completed the program. There was no blinding of either the practitioner or the patient, and this could have introduced bias. No objective measures of walking capacity or performance were used in this study, although many of the self-report outcomes used are highly correlated with objective walking ability. Only short-term outcomes were measured. Short-term self-report outcomes could have been influenced by the high level of attention provided to the patients during a short period. No long-term follow-up was conducted in this study, and therefore, the improvements in outcomes seen may diminish over time. Future study of the Boot Camp Program for Lumbar Stenosis is needed using more rigorous study designs.
Conclusions
This retrospective study provides preliminary evidence that a multifaceted intervention with an emphasis on self-management (Boot Camp Program for Lumbar Stenosis) may improve symptoms and functional status of patients with neurogenic claudication.
Practical Applications
•
The study demonstrates preliminary evidence for the effectiveness of the Boot Camp Program for DLSS.
•
All outcomes demonstrated both statistical and clinically important improvements at the completion of the program.
Funding Sources and Conflicts of Interest
This study was funded by the Canadian Chiropractic Research Foundation. No funding sources or conflicts of interest were reported for this study.
Contributorship Information
Concept development (provided idea for the research): C.A.
Design (planned the methods to generate the results): C.A.
Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): C.A.
Data collection/processing (responsible for experiments, patient management, organization, or reporting data): N.C., C.A.
Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): N.C., C.A.
Literature search (performed the literature search): C.A.
Writing (responsible for writing a substantive part of the manuscript): C.A.
Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): C.A.
References
Fanuele JC
Birkmeyer NJ
Abdu WA
Tosteson TD
Weinstein JN
The impact of spinal problems on the health status of patients: have we underestimated the effect?.
Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain.
Treadmill walking with body weight support is no more effective than cycling when added to an exercise program for lumbar spinal stenosis: a randomised controlled trial.
The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis.
Dynamic change of dural sac cross-sectional area in axial loaded magnetic resonance imaging correlates with the severity of clinical symptoms in patients with lumbar spinal canal stenosis.
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