Management of degenerative spondylolisthesis: development of appropriate use criteria.

BACKGROUND CONTEXT: Outcomes of treatment in care of patients with spinal disorders are directly related to patient selection and treatment indications. However, for many disorders, there is absence of consensus for precise indications. With the increasing emphasis on quality and value in spine care, it is essential that treatment recommendations and decisions are optimized. PURPOSE: The purpose of the North American Spine Society Appropriate Use Criteria was to determine the appropriate (ie reasonable) multidisciplinary treatment recommendations for patients with degenerative spondylolisthesis across a spectrum of more common clinical scenarios. STUDY DESIGN: A Modified Delphi process was used. METHODS: The methodology was based on the Appropriate Use Criteria development process established by the Research AND Development Corporation. The topic of degenerative spondylolisthesis was selected by the committee, key modifiers determined, and consensus reached on standard definitions. A literature search and evidence analysis were completed by one work group simultaneously as scenarios were written, reviewed, and finalized by another work group. A separate multidisciplinary rating group was assembled. Based on the literature, provider experience, and group discussion, each scenario was scored on a nine-point scale on two separate occasions, once without discussion and then a second time following discussion based on the initial responses. The median rating for each scenario was then used to determine if indications were rarely appropriate (1 - 3), uncertain (4-6), or appropriate (7-9). Consensus was not mandatory. RESULTS: There were 131 discrete scenarios. These addressed questions on bone grafting, imaging, mechanical instability, radiculopathy with or without neurological deficits, obesity, and yellow flags consisting of psychosocial and medical comorbidities. For most of these, appropriateness was established for physical therapy, injections, and various forms of surgical intervention. The diagnosis of spondylolisthesis should be determined by an upright x-ray. Scenarios pertaining to bone grafting suggested that patients should quit smoking prior to surgery, and that use of BMP should be reserved for patients who had risk factors for non-union. Across all clinical scenarios, physical therapy (PT) had an adjusted mean of 7.66, epidural steroid injections 5.76, and surgery 4.52. Physical therapy was appropriate in most scenarios, and most appropriate in patients with back pain and no neurological deficits. Epidural steroid injections were most appropriate in patients with radiculopathy. Surgery was generally more appropriate for patients with neurological deficits, higher disability scores, and dynamic spondylolisthesis. Mechanical back pain and presence of yellow flags tended to be less appropriate, and obesity in general had relatively little influence on decision making. Decompression alone was more strongly considered in the presence of static versus dynamic spondylolisthesis. On average, posterior fusion with or without interbody fusion was similarly appropriate, and generally more appropriate than stand-alone interbody fusion which was in turn more appropriate than interspinous spacers. CONCLUSIONS: Multidisciplinary appropriate treatment criteria were generated based on the Research AND Development methodology. While there were consistent and significant differences between surgeons and non-surgeons, these differences were generally very small. This document provides comprehensive evidence-based recommendations for evaluation and treatment of degenerative spondylolisthesis. The document in its entirety will be found on the North American Spine Society website (https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Appropriate-Use-Criteria).

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis.

BACKGROUND CONTEXT: The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adult Isthmic Spondylolisthesis features evidence-based recommendations for diagnosing and treating adult patients with isthmic spondylolisthesis. The guideline is intended to reflect contemporary treatment concepts for symptomatic isthmic spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2013. NASS' guideline on this topic is the only guideline on adult isthmic spondylolisthesis accepted in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse. PURPOSE: The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with isthmic spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. STUDY DESIGN: This is a guideline summary review. METHODS: This guideline is the product of the Adult Isthmic Spondylolisthesis Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questionsto address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Adult Isthmic Spondylolisthesis guideline was accepted into the National Guideline Clearinghouse and will be updated approximately every 5 years. RESULTS: Thirty-one clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. CONCLUSIONS: The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with isthmic spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule.

Membrane-Stabilizing Agents Improve Quality-of-Life Outcomes for Patients with Lumbar Stenosis.

Study Design Retrospective cohort controlled study. Objective To determine quality-of-life (QOL) outcomes for patients with lumbar spinal stenosis (LSS) treated with membrane-stabilizing agents (MSAs). Methods Patients with LSS and concordant neurogenic claudication treated with MSAs (n = 701) or conservatively without MSAs (n = 2104) at a single tertiary care hospital were identified. Patient QOL measures (Patient Health Questionnaire-9 [PHQ9], EuroQOL-5 Dimensions [EQ-5D], Pain Disability Questionnaire [PDQ]) were recorded pretreatment and then 4 months following treatment. Propensity score matching was used to account for baseline demographic differences between the two groups. The primary outcome measure was posttreatment improvement in these QOL measures. Results Patients in both groups had statistically significant improvements in the EQ-5D. However, the EQ-5D improvement in the MSA group was significantly greater than the improvement in the control group (0.11 versus 0.06; p = 0.0494). The EQ-5D change in the MSA group also exceeded the minimum clinically important difference, thereby suggesting a clinical significance. Both groups had significant pre- to posttreatment improvements in PDQ and PHQ-9, but these changes were not significantly different between the groups. Conclusion The results of this study suggest that patients with LSS and neurogenic claudication can have greater QOL improvements when treated with MSAs compared with other forms of conservative management without MSAs.

Prediction of quality of life improvements in patients with lumbar stenosis following use of membrane stabilizing agents.

OBJECTIVE: Membrane stabilizing agents (MSAs) improves function and reduces neuropathic pain in a subset of patients with LSS. No study has investigated the pre-treatment demographic and psychosocial factors associated with quality of life (QOL) outcomes following the use of MSAs. In this study we sought to create prediction models for post-treatment outcome. METHODS: All patients who were diagnosed with LSS and treated with MSAs at a single institution between September 2010 and March 2013 were retrospectively reviewed. QOL outcomes were collected prospectively. Prediction tools were created using multivariable logistic regression and Cox proportional hazard models. Outcome measures were: 1 - need for surgery within 1 year after initiating MSA treatment, 2 - time until surgery after initiating MSA treatment, 3 - any improvement in EuroQol (EQ)-5D QOL index, 4 - improvement in EQ-5D index exceeding the minimum clinically important difference (MCID). RESULTS: 1346 patients were included. For goal 1 (need for surgery), the prediction model was less robust. For goal 2 (time to surgery), only age was a significant predictor, with each 10-year increase in age causing the hazard of eventually having surgery to increase by 20%. 382 patients were available for analysis for goals 3 and 4 (predicting improvement in EQ-5D). Prediction models for these goals were good with C-statistics 0.73 and 0.85, respectively. Predictive factors for superior outcomes included lower baseline EQ-5D index (worse QOL), less baseline depression, greater median income, and being married. CONCLUSION: MSA treatment provides improvements in quality of life for those individuals with LSS. Treatment effects of MSAs will be greatest in those with worse quality of life, less depression, married patients, and those of higher socio-economic status.

Depression as a predictor of worse quality of life outcomes following nonoperative treatment for lumbar stenosis.

OBJECT: The goal of this study was to determine whether pretreatment depression is predictive of quality of life (QOL) improvement for patients with lumbar spinal stenosis (LSS) who are treated conservatively. METHODS: This retrospective cohort study included patients with LSS and concordant neurogenic claudication who were treated nonoperatively at a single institution between September 2010 and March 2013. Patient QOL measures were recorded pretreatment and then 4 months after treatment. Pretreatment depression was assessed using the Patient Health Questionnaire-9 (PHQ-9). Successful outcome was defined as posttreatment improvement in EuroQol-5D (EQ-5D) index or in Pain and Disability Questionnaire (PDQ) scores. Regression analysis was performed to identify independent predictors of outcome while controlling for confounding variables. RESULTS: A total of 502 patients were included in the study. The average age for these patients was 66.1 years, with 51% female and 90.6% white. After adjusting for baseline demographic and clinical variables, there was a statistically significant association between baseline PHQ-9 score and posttreatment change in EQ-5D index (ß = -0.007, p = 0.0002). All other things being equal, a patient with a baseline PHQ-9 score of 0 (no depression) would be expected to improve in the EQ-5D index by 0.14 points (greater than the minimum clinically important difference) more than would a patient with a baseline PHQ-9 score of 20 (major depression). There was no significant association between baseline PHQ-9 score and change in Pain and Disability Questionnaire scores. CONCLUSIONS: When controlling for other baseline characteristics, severely depressed patients with LSS who are treated nonoperatively have significantly less improvement in their QOL compared with those with little or no depression. These data are similar to the negative predictive effects of depression on posttreatment QOL following lumbar fusion surgery.

An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy.

BACKGROUND CONTEXT: The objective of the North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011. The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder. PURPOSE: To provide an evidence-based educational tool to assist spine specialists in the diagnosis and treatment of lumbar disc herniation with radiculopathy. STUDY DESIGN: Systematic review and evidence-based clinical guideline. METHODS: This guideline is a product of the Lumbar Disc Herniation with Radiculopathy Work Group of NASS' Evidence-Based Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. A literature search addressing each question and using a specific search protocol was performed on English-language references found in Medline, Embase (Drugs and Pharmacology), and four additional evidence-based databases to identify articles. The relevant literature was then independently rated using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were developed via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Level I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. RESULTS: Twenty-nine clinical questions were formulated and addressed, and the answers are summarized in this article. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. CONCLUSIONS: The clinical guideline has been created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with symptomatic lumbar disc herniation with radiculopathy. The entire guideline document, including the evidentiary tables, suggestions for future research, and all the references, is available electronically on the NASS Web site at http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule.

An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders.

BACKGROUND CONTEXT: The North American Spine Society (NASS) Evidence-Based Clinical Guideline on the Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders provides evidence-based recommendations on key clinical questions concerning the diagnosis and treatment of cervical radiculopathy from degenerative disorders. The guideline addresses these questions based on the highest quality clinical literature available on this subject as of May 2009. The guideline's recommendations assist the practitioner in delivering optimum efficacious treatment of and functional recovery from this common disorder. PURPOSE: Provide an evidence-based educational tool to assist spine care providers in improving quality and efficiency of care delivered to patients with cervical radiculopathy from degenerative disorders. STUDY DESIGN: Systematic review and evidence-based clinical guideline. METHODS: This report is from the Cervical Radiculopathy from Degenerative Disorders Work Group of the NASS' Evidence-Based Clinical Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. Each member of the group formatted a series of clinical questions to be addressed by the group. The final questions agreed on by the group are the subjects of this report. A literature search addressing each question using a specific search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology), and four additional evidence-based databases. The relevant literature was then independently rated by a minimum of three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were arrived at via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Levels I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. RESULTS: Eighteen clinical questions were formulated, addressing issues of natural history, diagnosis, and treatment of cervical radiculopathy from degenerative disorders. The answers are summarized in this article. The respective recommendations were graded by the strength of the supporting literature, which was stratified by levels of evidence. CONCLUSIONS: A clinical guideline for cervical radiculopathy from degenerative disorders has been created using the techniques of evidence-based medicine and best available evidence to aid both practitioners and patients involved with the care of this condition. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

BACKGROUND CONTEXT: The objective of the North American Spine Society (NASS) evidence-based clinical guideline on the diagnosis and treatment of degenerative lumbar spondylolisthesis is to provide evidence-based recommendations on key clinical questions concerning the diagnosis and treatment of degenerative lumbar spondylolisthesis. The guideline is intended to address these questions based on the highest quality clinical literature available on this subject as of January 2007. The goal of the guideline recommendations is to assist the practitioner in delivering optimum, efficacious treatment of and functional recovery from this common disorder. PURPOSE: To provide an evidence-based, educational tool to assist spine care providers in improving the quality and efficiency of care delivered to patients with degenerative lumbar spondylolisthesis. STUDY DESIGN: Systematic review and evidence-based clinical guideline. METHODS: This report is from the Degenerative Lumbar Spondylolisthesis Work Group of the NASS Evidence-Based Clinical Guideline Development Committee. The work group was comprised of multidisciplinary spine care specialists, all of whom were trained in the principles of evidence-based analysis. Each member participated in the development of a series of clinical questions to be addressed by the group. The final questions agreed on by the group are the subject of this report. A literature search addressing each question and using a specific search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology) and four additional, evidence-based, databases. The relevant literature was then independently rated by at least three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final grades of recommendation for the answer to each clinical question were arrived at via face-to-face meetings among members of the work group using standardized grades of recommendation. When Level I-IV evidence was insufficient to support a recommendation to answer a specific clinical question, expert consensus was arrived at by the work group through the modified nominal group technique and is clearly identified as such in the guideline. RESULTS: Nineteen clinical questions were formulated, addressing issues of prognosis, diagnosis, and treatment of degenerative lumbar spondylolisthesis. The answers to these 19 clinical questions are summarized in this document. The respective recommendations were graded by the strength of the supporting literature that was stratified by levels of evidence. CONCLUSIONS: A clinical guideline for degenerative lumbar spondylolisthesis has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to aid practitioners involved with the care of this condition. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

Evidence-informed management of chronic low back pain with opioid analgesics.

The management of chronic low back pain (CLBP) has proven to be very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence-Informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to nonexperts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP.

Degenerative lumbar spinal stenosis: an evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis.

BACKGROUND CONTEXT: The objective of the North American Spine Society (NASS) evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (DLSS) is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of DLSS. The guideline is intended to reflect contemporary treatment concepts for symptomatic DLSS as reflected in the highest quality clinical literature available on this subject as of April 2006. The goals of the guideline recommendations are to assist in delivering optimum, efficacious treatment, and functional recovery from this spinal disorder. PURPOSE: To provide an evidence-based tool that assists practitioners in improving the quality and efficiency of care delivered to patients with DLSS. STUDY DESIGN/SETTING: Evidence-based clinical guideline. METHODS: This report is from the Spinal Stenosis Work Group of the NASS Clinical Guidelines Committee. The work group comprised medical, diagnostic, interventional, and surgical spinal care specialists, all of whom were trained in the principles of evidence-based analysis. In the development of this guideline, the work group arrived at a consensus definition of a working diagnosis of lumbar spinal stenosis by use of a modification of the nominal group technique. Each member of the group formatted a series of clinical questions to be addressed by the group and the final list of questions agreed on by the group is the subject of this report. A literature search addressing each question and using a specific literature search protocol was performed on English language references found in MEDLINE, EMBASE (Drugs and Pharmacology), and four additional, evidence-based, databases. The relevant literature to answer each clinical question was then independently rated by at least two reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Any discrepancies in evidence levels among the initial raters were resolved by at least two additional members' review of the reference and independent rating. Final grades of recommendation for the answer to each clinical question were arrived at in face-to-face meetings among members of the work group using the NASS-adopted standardized grades of recommendation. When Levels I to IV evidence was insufficient to support a recommendation to answer a specific clinical question, expert consensus was arrived at by the work group through the modified nominal group technique and is clearly identified as such in the guideline. RESULTS: Eighteen clinical questions were asked, addressing issues of prognosis, diagnosis, and treatment of DLSS. The answers to these 18 clinical questions are summarized in this document along with their respective levels of evidence and grades of recommendation in support of these answers. CONCLUSIONS: A clinical guideline for DLSS has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to aid both practitioners and patients involved with the care of this disease. The entire guideline document including the evidentiary tables, suggestions for future research, and all references is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

Interpreting the Spine Patient Outcomes Research Trial. Medical vs surgical treatment of lumbar disk herniation: implications for future trials.

The Spine Patient Outcomes Research Trial (SPORT) consisted of two parallel studies: an observational study and a randomized comparison of medical and surgical treatment of disk herniation. In the long-term, patients did well with either treatment, and an intention-to-treat analysis found no difference in outcomes. However, at 2 years 40% of patients in the surgical group of the randomized study still hadn't had surgery, and 40% of the medical patients did have surgery, muddying the results. Surgery was superior according to an analysis by the treatment patients actually received, but the study has been criticized for methodologic shortcomings, and the topic remains controversial.

Medical management of cervical spondylosis.

Medical management is often the initial management of cervical spondylitic syndromes, including radiculopathy, myelopathy, and neck pain. This includes pharmacological and rehabilitation treatment. Prospective studies comparing the efficacy of surgical versus medical management are lacking. The indications and efficacy of pharmacological and rehabilitative treatments are reviewed. The use of anti-inflammatory drugs, muscle relaxants, analgesics, antidepressants, anticonvulsants, steroids, facet joint ablation, and physical therapy are reviewed. A rationale for the medical management of acute neck pain, chronic neck pain, radiculopathy, and myelopathy is presented.

Masquerade: medical causes of back pain.

Back pain has many causes, and 95% of cases are due to benign, self-limiting problems. Most problems are musculoskeletal and are relieved with rest and nonsteroidal medications. However, some serious and life-threatening medical conditions also can present as acute back pain.

Acute low back pain and radiculopathy: MR imaging findings and their prognostic role and effect on outcome.

PURPOSE: To prospectively determine in patients with acute low back pain (LBP) or radiculopathy, the magnetic resonance (MR) imaging findings, prognostic role of these findings, and effect of diagnostic information on outcome. MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained. This study was HIPAA compliant. A total of 246 patients with acute-onset LBP or radiculopathy were randomized to either the early information arm of the study, with MR results provided within 48 hours, or the second arm of the study, where both patients and physicians were blinded to MR results, unless this information was critical to patient care. Patients underwent 6 weeks of conservative care. Roland function scoring, visual pain analog, Short Form 36 health status survey, self-efficacy scoring, and a fear avoidance questionnaire were completed at presentation; at 2-, 4-, 6-, and 8-week follow-up; and at 6-, 12-, and 24-month follow-up. A second MR imaging examination was performed at 6-week follow-up. Multivariate logistic regression analysis was used to determine which imaging and nonimaging variables can be used to predict improvement in Roland function and patient satisfaction. The chi(2) test and repeated-measures analysis of variance were used to compare outcome of blinded and unblinded patients. RESULTS: Herniation was identified in 60% (n = 147) of patients at the initial examination. The prevalence of herniations in patients with LBP (57%) (n = 85) and those with radiculopathy (65%) (n = 62) were similar (P = .217), although patients with radiculopathy were more likely to have stenosis and nerve root compression (P < .006). There was no relationship between herniation type, size, and behavior over time with outcome. An improvement of 50% or more in Roland function score at 6-week follow-up occurred 2.7 times as often among patients with a herniation at baseline (P = .003). Improvement at 6-week follow-up was similar in unblinded (60%) (n = 55) and blinded (67%) (n = 57) patients (P = .397). Self-efficacy, fear avoidance beliefs, and the Short Form 36 subscales were similar for blinded and unblinded patients. CONCLUSION: In typical patients with LBP or radiculopathy, MR imaging does not appear to have measurable value in terms of planning conservative care. Patient knowledge of imaging findings does not alter outcome and is associated with a lesser sense of well-being.

Effectiveness of salmon calcitonin nasal spray in the treatment of lumbar canal stenosis: a double-blind, randomized, placebo-controlled, parallel group trial.

STUDY DESIGN: Double-blind, randomized, placebo-controlled study to assess the effectiveness of calcitonin nasal spray on symptoms and function in patients with lumbar canal stenosis. OBJECTIVE: To compare effectiveness of calcitonin administered by nasal spray with placebo in patients with clinically symptomatic lumbar canal stenosis. SUMMARY OF BACKGROUND DATA: Lumbar canal stenosis is the most common reason for spine surgery in individuals over 65 years of age. Nonoperative approaches have been not well studied and limited primarily to physical therapy exercises. Several small trials in the past have suggested that subcutaneous and intramuscular calcitonin is an effective nonsurgical option in treating the symptoms of spinal stenosis patients. Only three trials were randomized and placebo-controlled. METHODS: Fifty-five patients with clinical lumbar canal stenosis (pseudoclaudication), confirmatory MR imaging, and pain intensity index (VAS) of > or =6 were randomized to either placebo or intranasal calcitonin daily for 6 weeks, followed by an open label 6-week extension, during which all patients received active drug. Outcome parameters performed at baseline, 6 weeks, and 12 weeks, included pain intensity index, walking time and distance to pain, SF-36, and Oswestry disability index. RESULTS: Thirty-six patients received calcitonin, and 19 placebo. Eight (14.54%) calcitonin and 4 (7.27%) placebo patients withdrew from the study. The mean baseline pain score for calcitonin group was 7.8 and 7.5 for placebo. Comparisons at week 6 showed no statistically significant difference in the change in pain intensity (VAS) between calcitonin group (-2.9) and placebo (-2.4) (P = 0.4382) from baseline. There was no significant difference in walking time to pain (calcitonin -10.0 seconds; placebo +32.2 seconds; P = 0.5136). Walking distance to pain showed a mean improvement of +91.4 ft in the calcitonin group and +254.7 ft in the placebo group (P = 0.4948). No significant difference was observed in the SF-36 score between the treatment groups. Using a threshold of at least 50% reduction in pain from baseline to 6 weeks, 12 of 29 (41.37%) of calcitonin patients were considered responders versus 7 of 18 (38.88%) of placebo patients (P = 0.4238) CONCLUSIONS: In this first ever largest randomized placebo-controlled parallel group trial of nasal calcitonin in spinal stenosis, nasal calcitonin was not superior to placebo in treating the symptoms of spinal stenosis at 6 weeks. Based on this study, nasal calcitonin does not appear to have a role in nonoperative treatment of lumbar canal stenosis.

Large-array surface electromyography in low back pain: a pilot study.

STUDY DESIGN: A large-array surface electromyography device was used to collect data from healthy pain-free persons and from those with acute or chronic low back pain. Images of regional muscle electromyographic activity were assessed visually, and maximum root mean square values were compared statistically. OBJECTIVE: To determine whether data differs by patient type. SUMMARY OF BACKGROUND DATA: Whereas there is a good understanding of the anatomy and psychosocial aspects of low back pain, there is a need to understand better the physiology of low back pain. METHODS: Large-array surface electromyography data were collected from the low back muscles of 201 participants over a 3-month period using a 63-electrode fixed array and a standardized protocol. Color images representing the voltage root mean square difference of each electrode pair were created. Three images from each of three positions (standing upright, standing in 20 degrees of trunk flexion, standing holding weights) were collected from each participant. Serial studies were performed on the acute population over a 6-week follow-up period. RESULTS: Images of regional muscle activity from 92.7% of normal controls (n = 163) showed symmetrical activity. Patients with acute (n = 13) or chronic (n = 25) low back pain had multifocal and/or asymmetrical patterns. Symmetrical patterns returned in the three patients whose acute pain resolved during the study. Maximum root mean square values were higher among patients with acute (P = 0.03) and chronic (P = 0.04) pain than among control subjects. CONCLUSIONS: Large-array surface electromyography produced data from patients with back pain that differed from data on subjects without back pain. This method may be useful in evaluating patients with low back pain.

Vertebral compression fractures: manage aggressively to prevent sequelae.

New drugs to treat osteoporosis, along with two new minimally invasive surgical procedures, are important options for preventing vertebral compression fractures and treating severe back pain and disability. However, the mainstay treatments remain cautious use of analgesics, limited bed rest, and physical rehabilitation.

Lumbar canal stenosis: start with nonsurgical therapy.

Although surgery is widely viewed as the definitive therapy for lumbar spinal stenosis, no randomized trials have compared surgical vs medical treatment. One study found that 60% of surgically treated patients improved, compared with 30% of those treated nonsurgically. We believe an initial nonsurgical approach is advisable for most patients.