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Re: Whitman JM, Flynn TW, Childs JD, et al. A comparison between two physical therapy treatment programs for patients with lumbar spinal stenosis: a randomized clinical trial. Spine 2006;31 : 2541-9 - Reponse

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... A total of 1,220 participants (666 males and 554 females) were randomized to one of 25 comparison groups. Sixteen trials were conducted at tertiary care centres and two at medical/rehabilitation clinics [18, 27]. The mean age of participants was over 50 years in all trials. ...
... Although ten studies met six or more criteria, only five studies were considered to have low risk of bias [18,222324 31]. The remaining four studies that met six or more criteria failed to explicitly describe and/or use appropriate randomization procedure, allocation concealment or both [12, 16, 27, 32]. Other common risks of bias included the failure to blind the participants receiving the intervention or control1415161718192021222324252627282930; the failure to blind the treating health care provider [15, 18, 19, 21–24, 26–29, 31]; selective reporting, which meant data were not available [11, 12, 21]; and the lack of reporting of co-interventions (all included studies). ...
... The remaining four studies that met six or more criteria failed to explicitly describe and/or use appropriate randomization procedure, allocation concealment or both [12, 16, 27, 32]. Other common risks of bias included the failure to blind the participants receiving the intervention or control1415161718192021222324252627282930; the failure to blind the treating health care provider [15, 18, 19, 21–24, 26–29, 31]; selective reporting, which meant data were not available [11, 12, 21]; and the lack of reporting of co-interventions (all included studies). Evidence of effect of interventions Twenty-three of the 25 comparisons were examined in a single trial, most with small sample sizes (Table 3 ). ...
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To investigate what interventions can improve walking ability in neurogenic claudication with lumbar spinal stenosis. We searched CENTRAL, Medline, EMBASE, CINAHL and ICL databases up to June 2012. Only randomized controlled trials published in English and measuring walking ability were included. Data extraction, risk of bias assessment, and quality of the evidence evaluation were performed using methods of the Cochrane Back Review Group. We accepted 18 studies with 1,220 participants. There is very low quality evidence that calcitonin is no better than placebo or paracetamol regardless of mode of administration. There is low quality evidence that prostaglandins, and very low quality evidence that gabapentin or methylcobalamin, improves walking distance. There is low and very low quality evidence that physical therapy was no better in improving walking ability compared to no treatment, oral diclofenac plus home exercises, or combined manual therapy and exercise. There is very low quality evidence that epidural injections improve walking distance up to 2 weeks compared to placebo. There is low- and very low-quality evidence that various direct decompression surgical techniques show similar significant improvements in walking ability. There is low quality evidence that direct decompression is no better than non-operative treatment in improving walking ability. There is very low quality evidence that indirect decompression improves walking ability compared to non-operative treatment. Current evidence for surgical and non-surgical treatment to improve walking ability is of low and very low quality and thus prohibits recommendations to guide clinical practice.
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With the advancement of medicine and technology, along with improvements in preventative medicine, the average age of the US population continues to rise. Research estimates that by the year 2050, there will be more than 65 million older adults living, with 19 million being older than 85 years. As the population ages, more individuals will seek out physical therapy services for spine-related pathologies. Little evidence is currently available on the safety and effectiveness of manual therapy interventions in older adults. The purpose of this review was to discuss the safety and effectiveness of manual therapy interventions targeted at the thoracic spine in older individuals.
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A prospective observational cohort study. To assess long-term outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically. The relative benefit of various treatments for lumbar spinal stenosis is uncertain. Surgical treatment has been associated with short-term improvement, but recurrence of symptoms has been documented. Few studies have compared long-term outcomes of surgical and nonsurgical treatments. Patients recruited from the practices of orthopaedic surgeons, neurosurgeons, and occupational medicine physicians throughout Maine had baseline interviews with follow-up questionnaires mailed at regular intervals over 10 years. Clinical data were obtained at baseline from a physician questionnaire. Most patients initially undergoing surgery had a laminectomy without fusion performed. Outcomes including patient-reported symptoms of leg and back pain, functional status, and satisfaction were assessed at 8- to 10-year follow-up. Primary analyses were based on initial treatment received with secondary analyses examining actual treatment received by 10 years. Of 148 eligible consenting patients initially enrolled, 105 were alive after 10 years (67.7% survival rate). Among surviving patients, long-term follow-up between 8 and 10 years was available for 97 of 123 (79%) patients (including 11 patients who died before the 10-year follow-up but completed a 8 or 9 year survey); 56 of 63 (89%) initially treated surgically and 41 of 60 (68%) initially treated nonsurgically. Patients undergoing surgery had worse baseline symptoms and functional status than those initially treated nonsurgically. Outcomes at 1 and 4 years favored initial surgical treatment. After 8 to 10 years, a similar percentage of surgical and nonsurgical patients reported that their low back pain was improved(53% vs. 50%, P = 0.8), their predominant symptom (either back or leg pain) was improved (54% vs. 42%, P = 0.3), and they were satisfied with their current status (55% vs. 49%, P = 0.5). These treatment group findings persisted after adjustment for other determinants of outcome in multivariate models. However, patients initially treated surgically reported less severe leg pain symptoms and greater improvement in back-specific functional status after 8 to 10 years than nonsurgically treated patients. By 10 years, 23% of surgical patients had undergone at least one additional lumbar spine operation, and 39% of nonsurgical patients had at least one lumbar spine operation. Patients undergoing subsequent surgical procedures had worse outcomes than those continuing with their initial treatment. Outcomes according to actual treatment received at 10 years did not differ because individuals undergoing additional surgical procedures had worse outcomes than those continuing with their initial treatment. Among patients with lumbar spinal stenosis completing 8- to 10-year follow-up, low back pain relief, predominant symptom improvement, and satisfaction with the current state were similar in patients initially treated surgically or nonsurgically. However, leg pain relief and greater back-related functional status continued to favor those initially receiving surgical treatment. These results support a shared decision-making approach among physicians and patients when considering treatment options for lumbar spinal stenosis.
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To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. The revised checklist includes 22-items selected because empirical evidence indicates that not reporting the information is associated with biasedestimates of treatment effect or the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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The purpose of this case report is to describe a physical therapy approach to the evaluation, treatment, and outcome assessment of two patients diagnosed with lumbar spinal stenosis. Evaluation consisted of assessment of neurological status, spinal range of motion, and lower-extremity muscle force production and flexibility; administration of the Modified Oswestry Low Back Pain Questionnaire and the Roland-Morris Disability Questionnaire; assessment of pain using a visual analog scale; and performance of a two-stage treadmill test. The treatment program was designed to treat the impairments, and harness-supported treadmill ambulation (unloading) was used to address the limitation in ambulation identified by the treadmill test. Outcome assessment included measuring changes in the status of the impairments and assessing responses to the disability questionnaires and performance of the two-stage treadmill test. Improvements were noted on all outcome measures for both patients after 6 weeks of physical therapy and at the 4-week follow-up examination. Larger case series and randomized trials with long-term follow-ups are recommended.
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Low back pain is an extremely common, seriously disabling, nonfatal public health problem worldwide. The National Low Back Pain Study was a multicenter study of a large, heterogeneous group of patients who have been referred to either a neurosurgeon or an orthopedic surgeon for the evaluation and treatment of a persistent complaint of low back pain. In this paper, we characterize persistent low back pain patients and their complaints, describe the impact of persistent low back pain on the patients' functional and psychological status, report on the patients' medical characteristics, and identify treatments that are currently prescribed for these patients. Persistent low back pain is most common among people in their mid-to-late thirties and early-to-mid forties. The patients are mostly white, well educated, and generally affluent. The majority are gainfully employed, but some quit working because of pain and those who do tend to be less educated, and more likely to be involved in litigation. The average patient has had low back pain intermittently for 10 years. The pain is usually well localized but its severity varies considerably. Besides pain, most persistent low back pain patients report a variety of motor and sensory deficits. Patients also report significant functional impairment at work, at play, and at home. The typical patient does not, however, display significant psychological distress. Most patients have consulted multiple health care providers, have received a variety of treatments, and have used a variety of medications to alleviate pain; a few have been subjected to more aggressive treatment measures including surgery, intradiscal therapy, and narcotic and psychoactive drugs. None of these treatments has been effective. Physical examinations of these patients do not provide significant clues for making a definitive diagnosis. Nonspecific abnormalities such as muscle spasm, tenderness, and trigger points are quite common, but motor weakness and sensory deficits in the lower extremities, and reflex changes in the knees and ankles, are much less common. The classic combination of reflex changes, motor weakness, and sensory deficits associated with specific protruded discs are extremely rare even though one of three patients had a diagnosis of disc herniation. Diagnostic imaging studies revealed that the majority of persistent low back pain patients have spondylotic abnormalities involving root compression or lumbar instability or both, with root compression as the primary cause of the complaint. Myofascial syndrome and lumbar instability were the next most common diagnoses. After a thorough evaluation by specialists in spinal disorders, three of five persistent low back pain patients were prescribed an additional course of conservative therapy, one of five was prescribed surgery, and the rest were prescribed no treatment. Persistent low back pain patients appear to be a distinct group of low back pain patients who are different from patients who have similar nonpersistent acute symptoms and those who have the chronic pain syndrome characterized by significant behavioral and psychological co-morbidities. (C) Lippincott-Raven Publishers.
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The objective of this study was to compare the relative responsiveness of a condition-specific spinal stenosis measure and two generic health status measures for outcome assessment of surgery for degenerative lumbar spinal stenosis, and to examine whether responsiveness statistics and measures of the ability to distinguish clinically important improvement rank the instruments consistently. Physical function and symptom severity scales of the spinal stenosis measure were compared to the Sickness Impact Profile (SIP) and the Roland scale, which is derived from the SIP. Responsiveness was calculated with the standardized response mean, the effect size, and Guyatt's responsiveness statistic. The discriminative ability of the instruments to distinguish patients who improved from those who did not was assessed using satisfaction with surgery as an external criterion. Minimal clinically relevant improvement was estimated using patient satisfaction as the external criterion. All responsiveness statistics revealed the same order of responsiveness; the physical function scale (SRM = 1.07) and symptom severity scales (SRM = 0.96) were more responsive than the Roland scale (SRM = 0.77) which was only slightly more responsive than the SIP (SRM = 0.69). Strikingly, the physical dimension of the SIP (SRM = 0.62) was even less responsive than the global SIP. The shape of and the area under the ROC curves showed that the physical function and symptom severity scales discriminate better between satisfied and unsatisfied patients than the Roland scale and SIP. The sensitivity to detect clinically important changes was somewhat lower at the ends of the scales, especially for the SIP and the Roland scale. Statistical approaches that assess the ability to distinguish clinically important changes and overall responsiveness statistics ranked the measures consistently. On the basis of these findings, we suggest that a condition-specific spinal stenosis measure is preferable as the primary end point in evaluative studies of degenerative lumbar spinal stenosis.
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A meta-analysis was undertaken to determine the effects of surgery for lumbar spinal stenosis on pain and disability. Seventy-four journal articles met inclusion criteria and were independently reviewed by two readers. On average, 64% of patients treated surgically for lumbar spinal stenosis were reported to have good-to-excellent outcomes. However, there was wide variation across studies in the percentage with good outcomes. Few patient characteristics were found to predict outcome. Major deficits in study design, analysis, and reporting were common, and these precluded firm conclusions.
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The clinical course of 19 untreated patients with spinal stenosis (mean age, 60 years) was compared with that of 44 patients treated surgically (mean age, 65 years). The time of follow-up was 31 and 53 months, respectively. About 80% of the patients had neurogenic intermittent claudication. In the follow-up, one third of the treated and one half of the untreated patients still had neurogenic claudication. By visual analogue-scale estimation, 60% of those treated surgically and 33% of the untreated patients felt better. Fifty-eight percent of the untreated patients were unchanged. Neurophysiologic changes showed progression in almost all cases; it was more pronounced in the treated patients. No proof of severe deterioration was found in the untreated patients, and observation for 2-3 years seems to be a good alternative to surgery.
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The variation in the dimensions of the lumbar spinal canal under both flexion-extension and axial compression-distraction was studied using computerized tomography (CT) scans in human cadaver lumbar spine specimens. In 3-mm-thick CT slices through the disk at L3-L4, the cross-sectional area of the spinal canal was reduced by around 40 mm2, corresponding to a 16% reduction of the initial area when the lumbar spines were moved both from flexion to extension and from distraction to compression. A corresponding reduction in the midsagittal diameter of the canal of 2 mm was found. During these motions, the ligamentum flavum did not appear to be a significant factor for the dynamic changes affecting the dimensions of the canal. This held true even after the disk had been excised in order to produce a total collapse of the disk space.
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In 12 patients with myelographic evidence of bilateral root involvement at the L3-L4 or L4-L5 levels postmyelographic computerized tomography (CT) studies were performed in flexion and extension. They showed concentric narrowing of the spinal canal in extension and widening with relief of nerve root involvement in flexion. This could be attributed to the presence of marked degenerative hypertrophy of the facet joints, narrowing the available space for dural sac and emerging root sleeves. In extension of the lumbar spine, bulging of the disc toward the hypertrophic facets causes a pincers mechanism at the anterolateral angles of the spinal canal with the risk of bilateral root compression. This mechanism is enhanced in these cases by marked dorsal indentation of the dural sac because of anterior movement of the dorsal fat pad in extension. The authors believe that the radiologically described mechanism forms the anatomic basis of neurogenic claudication and posture-dependent sciatica.
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This in vitro study provides original data regarding the three-dimensional movements of the intervertebral foramen as the spine undergoes normal physiologic motions. Three-dimensional flexibility characteristics of fresh cadaver functional spinal units were determined. The same spinal units were fixed and thinly sectioned to yield quantitated anatomy of the soft and hard tissues of the specimen in three-dimensions. The flexibility and anatomic data were stored in a computer. A mathematical model was utilized to combine the two data sets, resulting in a precise three-dimensional description of the movements of the intervertebral foramen. Changes in foramen height, width, and area were obtained as functions of major spinal motions. Preliminary results indicate differences in intervertebral foramen kinematics of nondegenerated and degenerated spines. Such changes may affect the nerve root adversely and hence participate in pain production.
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This study is an analysis of national survey data from 5 sample years. The authors characterized the frequency of office visits for low back pain, the content of ambulatory care, and how these vary by physician specialty. Few recent data are available regarding ambulatory care for low back pain or how case mix and patient management vary by physician specialty. Data from the National Ambulatory Medical Care Survey were grouped into three time periods (1980-81, 1985, 1989-90). Frequency of visits for low back pain, referral status, tests, and treatments were tabulated by physician specialty. There were almost 15 million office visits for "mechanical" low back pain in 1990, ranking this problem fifth as a reason for all physician visits. Low back pain accounted for 2.8 percent of office visits in all three time periods. Nonspecific diagnostic labels were most common, and 56 percent of visits were to primary care physicians. Specialty variations were observed in caseload, diagnostic mix, and management. Back pain remains a major reason for all physician office visits. This study describes visit, referral, and management patterns among specialties providing the most care.
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This study describes recent United States trends and regional variations in the management of low back pain. The authors investigated recent temporal trends and compared practices in different geographic regions. Controversy exists concerning the appropriate medical and surgical management of patients with low back pain. National Hospital Discharge Survey data from 1979 through 1990 were analyzed. Case selection was based on previously developed algorithms intended to exclude nonmechanical causes of back pain. Over the period of study, nonsurgical hospitalizations for low back pain decreased dramatically. In contrast, low back operation rates, particularly for fusion surgery, increased substantially. In recent years, surgery and hospitalization rates were highest in the South and lowest in the West. Rapidly increasing surgical rates and wide geographic variations suggest the need for a more consistent approach to back problems.
Article
In this prospective study, 145 patients with lumbar spinal stenosis were evaluated for clinical signs and radiologic findings and conservative treatment results. Clinical parameters such as pain on motion, lumbar range of motion, straight leg raising test, deep tendon reflexes, dermatomal sensations, motor functions and neurogenic claudication distances were assessed at admission and were compared after a conservative treatment program was completed. A conservative treatment program consisted of physical therapy (infrared heating, ultrasonic diathermy and active lumbar exercises) and salmon calcitonin. Pain on motion (100%), restriction of extension (77%), limited straight leg raising test (23%), neurogenic claudication (100%), dermatomal sensory impairment (47%), motor deficit (29%), and reflex deficit (40%) were observed in the patients. All aforementioned disturbances except reflex deficits improved by the conservative treatment and results were statistically significant. The authors conclude that this conservative treatment should be the treatment of choice in elderly patients and in those patients without clinical surgical indications.
Article
To study temporal trends and geographic variations in the use of surgery for spinal stenosis, estimate short-term morbidity and mortality of the procedure, and examine the likelihood of repeat back surgery after surgical repair. Cohort study based on Medicare claims. Hospital care. All Medicare beneficiaries 65 years of age or older who received a lumbar spine operation for spinal stenosis in 1985 or 1989 were followed through 1991 (10,260 patients from the 1985 cohort and 18,655 from the 1989 cohort). Two outcomes were measured: (1) rates of operation for spinal stenosis by state and (2) on an individual level, operative complications (cardiopulmonary, vascular, or infectious), postoperative mortality, and time between first operation and any subsequent reoperation. Rates of surgery for spinal stenosis increased eightfold from 1979 to 1992 for patients aged 65 and older and varied almost fivefold among US states. Mortality and operative complications increased with age and comorbidity. Complications were more likely for men and for individuals receiving spinal fusions. The 1989 cohort experienced a slightly higher probability of reoperation than the 1985 cohort for the first 3 years of follow-up. A rapid increase in surgery rates for spinal stenosis was identified over a 14-year period. The wide geographic variations and substantial complication rate from this elective surgical procedure (partly related to patient age) suggest a need for more information on the relative efficacy of surgical and nonsurgical treatments for this condition. The risks and benefits of particular surgical procedures for specific clinical and demographic subgroups as well as individual patient preferences regarding surgical risks and possible outcomes should also be evaluated further. These issues are likely to become increasingly important with the aging of the US population.
Article
The measurement properties and validity of a newly developed patient questionnaire for the assessment of patients with lumbar spinal stenosis was tested in an ongoing prospective multicenter observational study of patients undergoing decompressive surgery in three teaching hospitals. The goal of the study was to develop a short, self-administered questionnaire on symptom severity, physical functional status, and patient satisfaction. The measure is intended to complement existing generic measures of spinal-related disability and health status. The questionnaire includes three scales with seven questions on symptom severity, five on physical function, and six on satisfaction. The internal consistency of the scales was assessed with Cronbach's coefficient alpha on cross-sectional data from 193 patients before surgery. The test-retest reliability was assessed on data from a random sample of 23 patients using Spearman's rank correlation coefficient. The responsiveness was assessed on 130 patients with 6-month follow-up data using the standardized response mean. The test-retest reliability of the scales ranged from 0.82 to 0.96, the internal consistency from 0.64 to 0.92, and the responsiveness from 0.96 to 1.07. The direction, statistical significance, and strength of hypothesized relationships with external criteria were as expected. This short self-administered spinal stenosis measure is reproducible, internally consistent, valid, and highly responsive. It can be used to complement generic instruments in outcome assessment of patients with lumbar spinal stenosis.
Article
A cadaveric study was done to analyze the dimensional changes in the spinal canal and intervertebral foramen of the lumber spine with flexion and extension movements. To investigate the relationship between flexion and extension movements and morphologic changes in the spinal canal and the intervertebral foramen. Previous studies have reported that the dimensions of the spinal canal and the intervertebral foramen may change significantly with motion. The purpose of this study was to assess the quantitative changes in the spinal canal and the intervertebral foramen with segmental flexion-extension movements. Nineteen fresh cadaveric spines yielding 25 motion segments were used. The lumbar motion segments were frozen and then imaged in axial and sagittal projections by a computed tomography scanner. They were thawed then, and the motion segments were loaded to 5.7 Nm in flexion (13 motion segments) and in extension (12 motion segments) specimens. While in flexion or extension, the specimens again were frozen and imaged by computed tomography scan. The frozen specimens than were sliced using a cryomicrotome in the sagittal plane to study the dimensions of the intervertebral foramen. Eighteen other fresh cadaveric spines were sliced sagittally for study in the neutral position. The axial computed tomography scans showed that extension significantly decreased the canal area, midsagittal diameter, and subarticular sagittal diameter, whereas flexion had the opposite effects. The sagittal computed tomography scans showed that extension decreased all the foraminal dimensions significantly, whereas flexion increased all the foraminal dimensions significantly. The translational changes were associated with the bulging of the disc and the presence of traction spurs. The cryomicrotome sections showed the cross-sectional area of the foramen to be 12% greater for the flexion group and 15% smaller for the extension group than the cross-sectional area of the neutral group. Nerve root compression in the foramen was found to be 21.0% in neutral, 15.4% in flexion, and 33.3% in extension groups. The study supports the concept of dynamic spinal stenosis. In addition to static anatomic changes, careful dynamic studies may be required to evaluate better the central canal and the foramen.
Article
The purpose of this case report is to describe a physical therapy approach to the evaluation, treatment, and outcome assessment of two patients diagnosed with lumbar spinal stenosis. Evaluation consisted of assessment of neurological status, spinal range of motion, and lower-extremity muscle force production and flexibility; administration of the Modified Oswestry Low Back Pain Questionnaire and the Roland-Morris Disability Questionnaire; assessment of pain using a visual analog scale; and performance of a two-stage treadmill test. The treatment program was designed to treat the impairments, and harness-supported treadmill ambulation (unloading) was used to address the limitation in ambulation identified by the treadmill test. Outcome assessment included measuring changes in the status of the impairments and assessing responses to the disability questionnaires and performance of the two-stage treadmill test. Improvements were noted on all outcome measures for both patients after 6 weeks of physical therapy and at the 4-week follow-up examination. Larger case series and randomized trials with long-term follow-ups are recommended.
Article
This study assesses the ability of a two-stage treadmill test to distinguish stenotic from nonstenotic subjects by capitalizing on the postural dependency of stenotic symptoms. Forty-five subjects (26 stenotic, 19 nonstenotic) participated. An earlier onset of symptoms with level walking (p = 0.0009), increased total walking time on an inclined treadmill (p = 0.014), and prolonged recovery time after level walking (p = 0.001) were significantly associated with stenosis. Only one of four self-reported postural variables were significantly associated with stenosis. Linear discriminant analysis performed using the treadmill variables resulted in the correct classification of 76.9 and 94.7% of stenotic and nonstenotic subjects, respectively. Likelihood ratios for all treadmill variables were > 2.50, and < 2.00 for all self-report variables. A two-stage treadmill test may be useful in the differential diagnosis of lumbar stenosis, and clinical measurement of the postural nature of symptoms seems to be superior to subjects' self-reports.
Article
In patients with sciatica or neurogenic claudication, the structures in and adjacent to the lumbar spinal canal were observed by computed tomographic myelography or magnetic resonance imaging in psoas-relaxed position and during axial compression in slight extension of the lumbar spine. To determine the mechanical effects on the lumbar spinal canal in a simulated upright position. For years, functional myelographic investigation techniques were shown to be of value in the evaluation of suspected encroachment of the spinal canal. Since the advent of computed tomography and magnetic resonance imaging, there have been few clinical and experimental attempts that have imitated these techniques. The data indicate that the space within the canal is posture dependent. Portable devices for axial loading of the lumbar spine in computed tomographic and magnetic resonance examinations were developed. Fifty patients (94 sites) were studied with computed tomographic myelography, and 34 patients (80 sites) with magnetic resonance in psoas-relaxed position followed by axial compression in slight extension. The dural sac cross-sectional area at L2 to S1, the deformation of the dural sac and the nerve roots, and the changes of the tissues surrounding the canal were observed. In 66 of the investigated 84 patients, there was a statistically significant reduction of the dural sac cross-sectional area in at least one site during axial compression in slight extension. Of the investigated patients, 29 passed the borderlines for relative (100 mm2) or absolute stenosis (75 mm2) in 40 sites. In 30 patients, there was deformation of the dural sac in 46 sites. In 11 of the patients investigated with magnetic resonance imaging, there was a narrowing of the lateral recess in 13 sites, during axial compression in slight extension. Axial loading of the lumbar spine in computed tomographic scanning and magnetic resonance imaging is recommended in patients with sciatica or neurogenic claudication when the dural sac cross-sectional area at any disc location is below 130 mm2 in conventional psoas-relaxed position and when there is a suspected narrowing of the dural sac or the nerve roots, especially in the ventrolateral part of the spinal canal in psoas-relaxed position. The diagnostic specificity of the spinal stenosis will increase considerably when the patient is subjected to an axial load.
Article
The present study focuses on the long-term prognosis of radiographically verified stenosis of the lower lumbar spine. The purpose here was to describe the outcome 12 years after radiographic diagnosis of spinal stenosis and to identify factors predicting disability after operative or conservative treatment. Data were compiled on 75 patients (43 men and 32 women) with changes in functional myelography diagnostic for spinal stenosis. Their mean age at the interview 12 years later was 61 years. The sagittal diameter of the dural sac was measured from baseline myelographs at all intervertebral levels and was corrected for magnification. In the interview, subjective outcome assessment was obtained with a structured questionnaire, and the low-back disorder was scored using the Oswestry disability index. The sagittal diameter of the dural sac was severely stenotic (<7.0 mm) in 32 patients (26 operated), and moderately stenotic (7.0-10.5 mm) in 43 patients (31 operated). The severity of the stenosis significantly predicted disability, even when the effects of age, sex, therapy regimen, and body mass index were adjusted for. For moderate and severe stenosis, the adjusted mean Oswestry indices were 28.4 and 39.1, respectively (p = 0.01). Therapy as such (operative versus nonoperative) did not significantly correlate with later disability. The radiographic severity of lumbar spinal stenosis predicts disability independently of therapy regimen. Randomized clinical trials are needed to establish the indications for surgical and conservative treatment. Radiographic severity of the stenosis should be considered as an effect-modifying or confounding factor in clinical trials and other studies focusing on the outcome of lumbar spinal stenosis.
Article
This study was carried out to evaluate the therapeutic effect of epidural steroid injection on pseudoclaudication in patients with lumbar degenerative spinal canal stenosis. Fifty-three patients who complained of pseudoclaudication of less than 20 m in walking distance were randomly divided into three groups. Group 1 (n = 16) underwent epidural injection with 8 ml of saline. Group 2 (n = 18) underwent epidural block with 8 ml of 1% mepivacaine. Group 3 (n = 19) underwent epidural block with a combination of 8 ml of 1% mepivacaine and 40 mg of methylprednisolone. The criteria of evaluation were as follows: excellent effect, > 100 m in walking distance; good effect, 20-100 m in walking distance; poor effect, <20 m in walking distance. In group 1, the numbers of patients who showed a good effect were two (12.5%) after 1 week, one (6.5%) after 1 month, and one (6.5%) after 3 months. In group 2, the numbers of patients who showed a good or excellent result were 10 (55.5%) after 1 week, three (16.7%) after 1 month, and one (5.6%) after 3 months. In group 3, the numbers of patients who showed a good or excellent result were 12 (63.2%) after 1 week, three (15.8%) after 1 month, and one (5.3%) after 3 months. There was no significant difference in the effectiveness of treatment between group 2 and group 3 throughout the time course. The results suggest that epidural steroid injection has no beneficial effect on the pseudoclaudication associated with spinal canal stenosis as compared with epidural block with a local anesthetic alone.
Article
A cohort study of nonoperatively treated patients with lumbar spinal stenosis. To assess the effectiveness of aggressive nonsurgical treatment for lumbar spinal stenosis. While surgical treatment of lumbar spinal stenosis has been widely accepted, the natural history of this condition is poorly documented. Moreover, the effect of other available therapies is unclear. Forty-nine patients meeting radiographic and clinical criteria for spinal stenosis underwent nonsurgical intervention consisting of therapeutic exercises, analgesics, and epidural steroid injections. Patients were followed for an average of 33 months. Outcome was assessed using a recently developed patient questionnaire for assessment of patients with lumbar spinal stenosis. Survival analysis was used to assess the probability of surgical intervention over the follow-up period. At 3 years following treatment, 9 of the 49 patients had undergone surgical intervention. Of the remaining 40 unoperated patients, it is reported that two suffered significant motor deterioration, one of whom still reported overall symptoms as mild improvement, and the other as definite worsening. Five of the 40 unoperated patients reported feeling overall symptoms as probably or definitely worse, 12 reported no change, 11 reported only mild improvement, and 12 reported sustained improvement. Twelve of the 40 unoperated patients also had none or only mild pain. The authors conclude that aggressive nonoperative treatment for spinal stenosis remains a reasonable option.
Article
The objective of this study was to evaluate the influence of decreased dural sac cross-sectional area and baseline clinical parameters on the outcome of patients treated surgically or conservatively for lumbar spinal stenosis. Computed tomography or magnetic resonance imaging scans of 37 patients were digitized and the dural sac cross-sectional area was calculated. This parameter and baseline clinical, socioeconomic, and anthropometric data of the patients were correlated with 1-year and 2-year follow-up data. The decrease in dural sac cross-sectional area negatively affected walking capacity on follow-up controls in patients treated conservatively, whereas such a relation was not observed among surgically treated patients. Female sex was the main parameter that worsened the global outcome of degenerative lumbar spinal stenosis, particularly after surgical treatment.
Article
A cohort of 100 patients with symptomatic lumbar spinal stenosis, characterized in a previous article, were given surgical or conservative treatment and followed for 10 years. To identify the short- and long-term results after surgical and conservative treatment, and to determine whether clinical or radiologic predictors for the treatment result can be defined. Surgical decompression has been considered the rational treatment. However, clinical experience indicates that many patients do well with conservative treatment. In this study, 19 patients with severe symptoms were selected for surgical treatment and 50 patients with moderate symptoms for conservative treatment, whereas 31 patients were randomized between the conservative (n = 18) and surgical (n = 13) treatment groups. Pain was decisive for the choice of treatment group. All patients were observed for 10 years by clinical evaluation and questionnaires. The results, evaluated by patient and physician, were rated as excellent, fair, unchanged, or worse. After a period of 3 months, relief of pain had occurred in most patients. Some had relief earlier, whereas for others it took 1 year. After a period of 4 years, excellent or fair results were found in half of the patients selected for conservative treatment, and in four fifths of the patients selected for surgery. Patients with an unsatisfactory result from conservative treatment were offered delayed surgery after 3 to 27 months (median, 3.5 months). The treatment result of delayed surgery was essentially similar to that of the initial group. The treatment result for the patients randomized for surgical treatment was considerably better than for the patients randomized for conservative treatment. Clinically significant deterioration of symptoms during the final 6 years of the follow-up period was not observed. Patients with multilevel afflictions, surgically treated or not, did not have a poorer outcome than those with single-level afflictions. Clinical or radiologic predictors for the final outcome were not found. There were no dropouts, except for 14 deaths. The outcome was most favorable for surgical treatment. However, an initial conservative approach seems advisable for many patients because those with an unsatisfactory result can be treated surgically later with a good outcome.
Article
A prospective study of 17,774 patients who consulted spine centers in which the impact of spinal disorders and comorbidities on physical functional status were evaluated. To quantify the effect spinal diagnoses have on patients' physical functional status (SF-36 Physical Component Summary [PCS] score) compared with other common conditions and to quantify the effects of comorbidities on physical functional status in spine patients. The burden of spinal conditions on a patient's function and the role that comorbidities play in this affliction are poorly quantified in the literature. Data from the Health Survey Questionnaire were prospectively gathered through the National Spine Network, a nonprofit consortium of spine-focused practices. Each patient's SF-36 score was summarized into a single PCS score. The correlation between diagnosis and comorbidity and PCS score was assessed using multivariate linear regression. The study patients were a mean of 47.5 years of age, 54.7% were female, 52.3% had lumbosacral diagnoses, and 82.0% had had 3 or more months of pain. The population had a mean PCS score of 30.4 +/- 9.95 (SD) compared with 50.0 +/- 10.00 for the general United States population. The more comorbidities in a patient, the lower the PCS score (Spearman rank correlation = -0.27). The five comorbid conditions that lowered the PCS the most included congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), renal failure, rheumatoid arthritis, and lupus (all P <0.001). In multiple linear regression analysis, age, gender, diagnosis, and comorbidity explained 12.1% of the variance in PCS score. The PCS score is greatly affected in patients with spinal problems. The study population's PCS (30.4) was lower or similar to the PCS for patients with other illnesses reported in the literature: CHF (31.0), COPD (33.9), SLE (37.1), cancer (38.4), primary total hip arthroplasty (29.0), primary total knee arthroplasty (32.6), and glenohumeral degenerative joint disease (35.2). Further, the presence of comorbidity in spine patients adds to the burden of spinal conditions on functional status.
Article
The quality of a disability scale should dictate when it is used. The purposes of this study were to examine the validity of a global rating of change as a reflection of meaningful change in patient status and to compare the measurement properties of a modified Oswestry Low Back Pain Disability Questionnaire (OSW) and the Quebec Back Pain Disability Scale (QUE). Sixty-seven patients with acute, work-related low back pain referred for physical therapy participated in the study. The 2 scales were administered initially and after 4 weeks of physical therapy. The Physical Impairment Index, a measure of physical impairment due to low back pain, was measured initially and after 2 and 4 weeks. A global rating of change survey instrument was completed by each subject after 4 weeks. An interaction existed between patients defined as improved or stable based on the global rating using a 2-way analysis of variance for repeated measures on the impairment index. The modified OSW showed higher levels of test-retest reliability and responsiveness compared with the QUE. The minimum clinically important difference, defined as the amount of change that best distinguishes between patients who have improved and those remaining stable, was approximately 6 points for the modified OSW and approximately 15 points for the QUE. The construct validity of the global rating of change was supported by the stability of the Physical Impairment Index across the study period in patients defined as stable by the global rating and by the decrease in physical impairment across the study period in patients defined as improved by the global rating. The modified OSW demonstrated superior measurement properties compared with the QUE.
Article
We carried out a retrospective review of 155 patients with lumbar spinal stenosis who had been treated surgically and followed up regularly: 77 were evaluated at a mean of 6.5 years (5 to 8) after surgery by two independent observers. The outcome was assessed using the scoring system of Roland and Morris, and the rating system of Prolo, Oklund and Butcher. Instability was determined according to the criteria described by White and Panjabi. A significant decrease in low back pain and disability was seen. An excellent or good outcome was noted in 79% of patients; 9% showed secondary radiological instability. Surgical decompression is a safe and efficient procedure. In the absence of preoperative radiological evidence of instability, fusion is not required.
Article
Spinal degeneration leading to spinal stenosis is increasingly common in an aging population. Many patients are not referred for operation because of the fear of severe complications. The purpose of this study was to relate the surgical risks involved in elective spinal decompression in elderly patients to those of total hip arthroplasty, a well-accepted procedure whose risks and benefits are well known. We reviewed the charts of 6 8 consecutive patients who underwent elective spinal decompression and fitted our inclusion criteria (65-80 yr of age, no spinal or hip operations, no hip fractures, spine fractures or cauda equina syndrome and no bone or metastatic disease). This group was matched with a similar group of 68 randomly selected patients who underwent total hip arthroplasty during the same period. We recorded the age, gender, American Society of Anesthesiologists (ASA) score, early postoperative complication rate, operative time, hospital stay and blood lost. The 2 groups were well matched with respect to age, gender and ASA score. The only significant intraoperative difference was operative time, with the spine procedure taking longer to complete (191 min v. 278 min). Blood loss was not significantly different. Both groups had a similar number of lift-threatening complications (12 v. 14). The number of minor complications was greater in the spinal decompression group (62 v. 125). Elective lumbar spinal decompression in elderly patients suffering significant pain or disability due to degenerative lumbar spinal stenosis is worthwhile. We recommend judicious use of conservative measures, but encourage referral for surgical management when these fail. This operation, even when instrumentation and bone grafting are required, is not associated with more serious or life-threatening risks than a total hip replacement in elderly patients.
Article
A consecutive case retrospective chart review and an outcome satisfaction questionnaire were used in this study. To provide a surgical reference for surgeons and elderly patients who may have concerns regarding the safety and outcome of lumbar spine surgery in their age population. Elderly patients scheduled for spine surgery have a major concern about the safety and outcome of the procedure in light of their advanced age. A review of the literature demonstrated conflicting results regarding the outcome of lumbar spine surgery for spinal stenosis in the elderly. A retrospective review evaluated 118 consecutive patients ages 70 to 101 years who were managed surgically for lumbar spinal stenosis. This patient population was analyzed for the operative procedure, postoperative morbidity and mortality, and long-term clinical outcome and satisfaction. All 118 patients had at least a 2-year follow-up evaluation, and 21 of these patients were older than 80 years. Clinical parameters were compiled and analyzed on the basis of chart review. Overall morbidity occurred in 24 patients (20%). During the study period, the average length of hospitalization declined an average of 2 days. Of the 118 patients, 109 expressed satisfaction with the operation and resumed daily activities, whereas 9 had fair or poor results. Advanced age did not increase the morbidity associated with this operation because the results reported in this study are comparable with those from other studies of a younger population, nor did advanced age decrease patient satisfaction or return to activities.
Article
This article critically reviews the available literature regarding nonsurgical management for lumbar spinal stenosis (LSS) and presents a case series of three patients managed with manual physical therapy. This case series uses a well-defined, impairment-based, noninvasive, outpatient treatment program for patients with LSS and provides patient-centered, long-term outcome information. The outpatient treatment program focuses on patients' individualized, prioritized impairments identified on initial examination, and emphasizes manual physical therapy techniques targeting each patient's impairments, specific exercises to either reinforce the manual physical therapy treatment or strengthen specific muscles, and a walking program. The results demonstrate that patients with LSS can make significant gains in disability, symptoms, and function in relatively short periods of time and that these gains can be maintained for up to 18 months. Under this physical therapy program, patients experienced significant improvements, and the potential adverse effects of invasive therapies or pharmacologic management strategies, which often are included in other "nonsurgical" treatment programs, were avoided.
Article
To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow- up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
Article
Lumbar arthrodesis is commonly done in elderly patients to treat degenerative spine problems. These patients may be at increased risk for complications because of their age and associated medical conditions. In this study, we examined the rates of perioperative complications associated with posterior lumbar decompression and arthrodesis in patients sixty-five years of age or older. We reviewed the hospital records of ninety-eight patients who were sixty-five years of age or older when they had a posterior decompression and lumbar arthrodesis with instrumentation, between 1993 and 1995, to treat degenerative disease of the spine. The average age was seventy-two years (range, sixty-five to eighty-four years). Perioperative complications occurred in seventy-eight patients. Twenty-one patients had at least one major complication, and sixty-nine had at least one minor complication. Forty-nine patients had more than one complication. The most common major complication was wound infection (prevalence, 10%), and the most common minor complication was urinary tract infection (prevalence, 34%). The complication rate increased with older age, increased blood loss, longer operative time, and the number of levels of the arthrodesis. Surgeons should be vigilant about perioperative complications in elderly patients treated with multi-level lumbar decompression and arthrodesis with instrumentation. Elderly patients should be made aware that they are at increased risk for surgical complications because of their age. Attention should be paid to controlling blood loss and limiting operative time.
Article
To assess the relative effect of initial surgical and nonsurgical treatment on longitudinal outcomes of patients with lumbar spinal stenosis over a 10-year follow-up period. A prospective observational cohort study. Enrollment from community-based specialist practices throughout Maine. One hundred forty-four patients with lumbar spinal stenosis who had at least one follow-up: 77 initially treated surgically and 67 initially treated nonsurgically. Initial surgical or nonsurgical treatment. Clinical data were obtained at baseline and outcomes followed at regular intervals over 10 years with mailed questionnaires including patient-reported symptoms of back pain, leg symptoms, back-specific functional status, and satisfaction. Longitudinal data were analyzed using general linear mixed models. In addition to treatment (initial surgical or nonsurgical care), time period, and the interaction between treatment and time, the models included baseline score, patient age and sex, and a time-varying general health status score. The effects of these covariates in explaining differences between treatment groups were also examined. The effect of subsequent surgical procedures was assessed using different analysis strategies. The 10-year rate of subsequent surgical procedures was 23% and 38% for patients initially treated surgically and nonsurgically, respectively, and the overall 10-year survival rate was 69%. Patients undergoing initial surgical treatment had worse baseline symptoms and functional status than those initially treated nonsurgically. For all outcomes and at each time point, surgically treated patients reported greater improvement in symptoms and functional status and higher satisfaction scores, indicative of better outcomes, than nonsurgically treated patients. However, the relative magnitude of the benefit diminished over time such that the relative differences for low back pain and satisfaction were no longer significant over long-term follow-up (both P=.08 for treatment effect between 5 and 10 years after controlling for covariates). Regardless of initial treatment received, patients undergoing subsequent surgical procedures reported less improvement in outcomes over time than patients who did not undergo subsequent procedures, but the relative differences between treatment groups were similar in analyses that controlled for outcomes after subsequent procedures. After controlling for covariates, patients initially treated surgically demonstrated better outcomes on all measures than those initially treated nonsurgically. Although outcomes of initial surgical treatment remained superior over time, the relative benefit of surgery diminished in later years, especially for low back pain and satisfaction. Patients undergoing subsequent surgery had worse outcomes regardless of initial treatment received, but excluding them did not change overall treatment group comparisons. The analytical methods described may be helpful in the design and analysis of future studies comparing treatment outcomes for patients with lumbar spinal stenosis.
Article
Cohort study of patients with low back pain (LBP) receiving physical therapy. To examine the responsiveness characteristics of the numerical pain rating scale (NPRS) in patients with LBP using a variety of methods. Although several studies have assessed the reliability and validity of the NPRS, few studies have characterized its responsiveness in patients with LBP. Determination of change on the NPRS during 1 and 4 weeks was examined by calculating mean change, standardized effect size, Guyatt Responsiveness Index, area under a receiver operating characteristic curve, minimum clinically important difference, and minimum detectable change. Change in the NPRS from baseline to the 1 and 4-week follow-up was compared to the average of the patient and therapist's perceived improvement using the 15-point Global Rating of Change scale. The majority of patients had clinically meaningful improvement after both 1 and 4 weeks of rehabilitation. The standard error of measure was equal to 1.02, corresponding to a minimum detectable change of 2 points. The area under the curve at the 1 and 4-week follow-up was 0.72 (0.62, 0.81) and 0.92 (0.86, 0.97), respectively. The minimum clinically important difference at the 1 and 4-week follow-up corresponded to a change of 2.2 and 1.5 points, respectively. Clinicians can be confident that a 2-point change on the NPRS represents clinically meaningful change that exceeds the bounds of measurement error.
Article
Retrospective cohort study using national sample administrative data. To determine if lumbar fusion rates increased in the 1990s and to compare lumbar fusion rates with those of other major musculoskeletal procedures. Previous studies found that lumbar fusion rates rose more rapidly during the 1980s than did other types of lumbar surgery. We used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample from 1988 through 2001 to examine trends. U.S. Census data were used for calculating age and sex-adjusted population-based rates. We excluded patients with vertebral fractures, cancer, or infection. In 2001, over 122,000 lumbar fusions were performed nationwide for degenerative conditions. This represented a 220% increase from 1990 in fusions per 100,000. The increase accelerated after 1996, when fusion cages were approved. From 1996 to 2001, the number of lumbar fusions increased 113%, compared with 13 to 15% for hip replacement and knee arthroplasty. Rates of lumbar fusion rose most rapidly among patients aged 60 and above. The proportion of lumbar operations involving a fusion increased for all diagnoses. Lumbar fusion rates rose even more rapidly in the 90s than in the 80s. The most rapid increases followed the approval of new surgical implants and were much greater than increases in other major orthopedic procedures. The most rapid increases in fusion rates were among adults aged 60 and above. These increases were not associated with reports of clarified indications or improved efficacy, suggesting a need for better data on the efficacy of various fusion techniques for various indications.
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87 to 11.23) 10.48 (6.5 to 14.4) 3.93 (2.07 to 9.93) Baseline to 1-year follow-up 5
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