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OBJECTIVE This abbreviated version of the American College of Occupational and Environmental Medicine's (ACOEM) Low Back Disorders Guideline reviews the evidence and recommendations developed for non-invasive and minimally invasive management of low back disorders. METHODS Systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking. A total of 70 high-quality and 564 moderate-quality trials were identified for non-invasive low back disorders. Detailed algorithms were developed. RESULTS Guidance has been developed for the management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 121 specific recommendations. CONCLUSION Quality evidence should guide treatment for all phases of managing low back disorders.

OBJECTIVE This abbreviated version of the American College of Occupational and Environmental Medicine's Low Back Disorders guideline reviews the evidence and recommendations developed for invasive treatments used to manage low back disorders. METHODS Comprehensive systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking and often relied on analogy to other disorders for which evidence exists. A total of 47 high-quality and 321 moderate-quality trials were identified for invasive management of low back disorders. RESULTS Guidance has been developed for the invasive management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 49 specific recommendations. CONCLUSION Quality evidence should guide invasive treatment for all phases of managing low back disorders.

Objective To compare changes in quality of life (QOL) that resulted from sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) in a real-world clinical setting. Background SLIT is established as a viable alternative to SCIT for the treatment of allergic rhinitis. Although comparative trials are increasingly available, few studies have examined QOL outcomes between these two treatments. Methods One hundred and five participants who underwent immunotherapy for airborne allergies were enrolled in this prospective, single-center study. Forty participants completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at initiation of therapy, after 6 months, and after 1 year of therapy. Only patients with complete time points were included in the ultimate analysis. Twenty-nine of these participants underwent SCIT and 11 underwent SLIT. The effects of age, sex, and asthma history were also examined. Results The participants in both groups demonstrated improvements in QOL regarding allergic rhinoconjunctivitis over the study period. However, the change in the RQLQ score from both baseline to 6 months and baseline to 1 year was only statistically significant in the SCIT group (p = 0.002, 6 months and 1 year). The participants in the SCIT group also demonstrated statistically significant improvement from baseline to 1 year in the specific domains of practical and emotional functioning, nasal symptoms, non-nasal/eye symptoms, and sleep. After 1 year, both SCIT and SLIT demonstrated a minimally important difference from baseline in the overall RQLQ score. Age Conclusion Although improvements in QOL were noted in both groups, changes in overall scores and the majority of domains only achieved statistical significance in the SCIT group. A small study population and difficulties adhering to immunotherapy dosing schedules in the SLIT group may be contributing factors.

Background context Provocative discography, an invasive diagnostic procedure involving disc puncture with pressurization, is a test for presumptive discogenic pain in the lumbar spine. The clinical validity of this test is unproven. Data from multiple animal studies confirm that disc puncture causes early disc degeneration. A recent study identified radiographic disc degeneration on magnetic resonance imaging (MRI) performed 10 years later in human subjects exposed to provocative discography. The clinical effect of this disc degeneration after provocative discography is unknown. Purpose The aim of this study was to investigate the clinical effects of lumbar provocative discography on patients subjected to this evaluation method. Study design/setting A prospective, 10-year matched cohort study. Patient sample Subjects (n=75) without current low back pain (LBP) problems were recruited to participate in a study of provocative discography at the L3–S1 discs. A closely matched control cohort was simultaneously recruited to undergo a similar evaluation except for discography injections. Outcome measures The primary outcome variables were diagnostic imaging events and lumbar disc surgery events. The secondary outcome variables were serious LBP events, disability events, and medical visits. Methods The discography subjects and control subjects were followed by serial protocol evaluations at 1, 2, 5, and 10 years after enrollment. The lumbar disc surgery events and diagnostic imaging (computed tomography (CT) or MRI) events were recorded. In addition, the interval and cumulative lumbar spine events were recorded. Results Of the 150 subjects enrolled, 71 discography subjects and 72 control subjects completed the baseline evaluation. At 10-year follow-up, 57 discography and 53 control subjects completed all interval surveillance evaluations. There were 16 lumbar surgeries in the discography group, compared with four in the control group. Medical visits, CT/MRI examinations, work loss, and prolonged back pain episodes were all more frequent in the discography group compared with control subjects. Conclusion The disc puncture and pressurized injection performed during provocative discography can increase the risk of clinical disc problems in exposed patients.

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

A prospective cohort study.To evaluate whether an annular closure device could be implanted safely to reduce same-level recurrent disk herniation, or attenuate disk height loss and improve the outcome after lumbar discectomy.Same-level recurrent disk herniation, disk height loss, and progressive degeneration are common complications and sequelae after lumbar discectomy. Techniques to reduce these consequences may improve outcomes.Forty-six consecutive patients undergoing lumbar discectomy for single-level herniated disk at 2 institutions were followed prospectively with clinical and radiographic evaluations at 6 weeks and 3, 6, 12, and 24 months (control cohort). A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed similarly. Incidence of recurrent disk herniation, disk height loss, the leg and back pain visual analog scale (VAS), and the Oswestry Disability Index were assessed at each follow-up.Cohorts were well matched at baseline. By 2 years of follow-up, symptomatic recurrent same-level disk herniation occurred in 3 (6.5%) patients in the control cohort versus 0 (0%) patients in the annular repair cohort (P=0.27). A trend of greater preservation of disk height was observed in the annular repair versus the control cohort 3 months (7.9 vs. 7.27 mm, P=0.08), 6 months (7.81 vs. 7.18 mm, P=0.09), and 12 months (7.63 vs. 6.9 mm, P=0.06) postoperatively. The annular closure cohort reported less leg pain (VAS-LP: 5 vs. 16, P0.01), back pain (VAS-BP: 13 vs. 22, P0.05), and disability (Oswestry Disability Index: 16 vs. 22, P0.05) 1 year postoperatively.Implantation of a novel annular repair device was associated with greater maintenance of disk height and improved 1-year leg pain, back pain, and low-back disability. Recurrent disk herniation did not occur in any patient after annular repair. Closure of annular defect after lumbar discectomy may help preserve the physiological disk function and prevent long-term disk height loss and associated back and leg pain.

Commentary on Pourtaheri S, Emami A, Sinha K, Faloon M, Hwang K, Shafa E, et al. The role of magnetic resonance imaging in acute cervical spine fractures. Spine J 2014;14:2546–53 ( in this issue ).

Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a growth factor known to have in vitro effects on the growth and invasiveness of cancer. It has been approved by the U.S. Food and Drug Administration in limited doses for single-level anterior spinal arthrodesis, but it is commonly used off-label and at high doses. The effect of rhBMP-2 on the risk of cancer has been a concern. We sought to evaluate the risk of new cancers in patients receiving high-dose rhBMP-2. Methods: We used publicly available data from a pivotal, multicenter, randomized controlled trial of patients with degenerative lumbar spine conditions who underwent a single-level instrumented posterolateral arthrodesis with either high-dose rhBMP-2 in a compression-resistant matrix (CRM) (rhBMP-2/CRM; n = 239) or autogenous bone graft (control group; n = 224). We compared the risks of new cancers in the rhBMP-2/CRM and control groups at two and five years after surgery. Results: At two years, with 86% follow-up, there were fifteen new cancer events in eleven patients in the rhBMP-2/CRM group compared with two new cancer events in two patients in the control group treated with autogenous bone graft. The incidence rate of new cancer events per 100 person-years was 3.37 (95% confidence interval [CI], 1.89 to 5.56) in the rhBMP-2/CRM group at two years compared with 0.50 (95% CI, 0.06 to 1.80) in the control group. The incidence rate ratio was 6.75 (95% CI, 1.57 to 60.83; p = 0.0026) at two years. Calculated in terms of the number of patients with one or more cancer events two years after the surgery, the incidence rate per 100 person-years was 2.54 (95% CI, 1.27 to 4.54) in the rhBMP-2/CRM group compared with 0.50 (95% CI, 0.06 to 1.82) in the control group at two years; the incidence rate ratio was 5.04 (95% CI, 1.10 to 46.82; p = 0.0194). At five years, there was a 37% loss of follow-up, but a significantly greater incidence of cancer events was still observed in the rhBMP-2/CRM group. Conclusions: A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

STUDY DESIGN A retrospective cohort design. OBJECTIVE To determine whether baseline magnetic resonance imaging findings, including central/foraminal stenosis, Modic change, disc morphology, facet arthropathy, disc degeneration, nerve root impingement, and thecal sac compression, are associated with differential surgical treatment effect. SUMMARY OF BACKGROUND DATA Intervertebral disc herniation remains the most common source of lumbar radiculopathy treated either with discectomy or nonoperative intervention. Although magnetic resonance imaging remains the reliable "gold standard" for diagnosis, uncertainty surrounds the relationship between magnetic resonance imaging findings and treatment outcomes. METHODS Three hundred seven "complete" images from patients enrolled in a previous trial were de-identified and evaluated by 1 of 4 independent readers. Findings were compared with outcome measures including the Oswestry Disability Index. Differences in surgery and nonoperative treatment outcomes were evaluated between image characteristic subgroups and TE determined by the difference in Oswestry Disability Index scores. RESULTS The cohort comprised 40% females with an average age of 41.5 (±11.6) years, 61% of whom underwent discectomy for intervertebral disc herniation. Patients undergoing surgery with Modic type I endplate changes had worse outcomes (-26.4 vs. -39.7 for none and -39.2 for type 2, P = 0.002) and smaller treatment effect (-3.5 vs. -19.3 for none and -15.7 for type 2, P = 0.003). Those with compression of ≥1/3 showed the greatest improvement within the surgical group (-41.9 for ≥1/3 vs. -31.6 for none and -38.1 for

Objective To determine the presence of a fibronectin-aggrecan complex (FAC) in the disk space of persons with chronic low back pain as relates to provocative diskography. Design A single-center prospective consecutive case series. Setting A single private practice setting. Patients Thirty-seven patients with symptomatic degenerative disk disease of the cervical, thoracic, or lumbar spine undergoing provocative diskography to identify a source of pain. Methods Diskographic lavage for analysis was simultaneously performed at each disk level injected during diskography. Main Outcome Measures Visual analog scale (VAS) pain scores, Pfirrmann magnetic resonance imaging grade, and biochemical analysis of disk material were statistically analyzed. Results A total of 105 levels in 37 patients had a complete set of data (mean age 43.2 ± 11.9 years; 15 male/22 female). The FAC was present in 43 of 108 levels and in at least one level in 25 of 37 patients. The Pfirrmann magnetic resonance imaging grade did not differ between complex-positive and negative levels ( P = .125), nor did the intraoperative VAS (IO-VAS) score for pain by level ( P = .206). A significant but loose correlation was found between Pfirrmann grade and IO-VAS ( R 2 = 0.4, P R 2 = 0.08, P = .11 and R 2 = 0.003, P = .5). Conclusions The FAC was identified in some painful disks by diskography. There was no significant correlation between the Pfirrmann grade or pre/intraoperative pain scores during diskography and complex concentrations within the disk measured by disk lavage.

Background context Ankylosing spondylitis (AS) is a major subtype of the spondyloarthropathies. Uncoupling of bone formation and resorption along with ectopic ossification of paraspinal soft-tissue structures alters the biomechanics of the spine and leads to an increased susceptibility to fracture. Purpose To report on a thoracolumbar fracture dislocation sustained in a 33-year-old Gravida 2/Para 2 woman, which occurred during labor. Although there are several reports in the literature of thoracolumbar fracture dislocations sustained in patients with AS, none have been reported during childbirth. Study design Case report. Conclusions An elevated suspicion for injury should be maintained when patients with AS present with back or neck pain even without a history of significant trauma.

Background context Spinal cord injury can lead to severe functional impairments secondary to axonal damage, neuronal loss, and demyelination. The injured spinal cord has limited regrowth of damaged axons. Treatment remains controversial, given inconsistent functional improvement. Previous studies demonstrated functional recovery of rats with spinal cord contusion after transplantation of rat fetal neural stem cells. Purpose We hypothesized that acute transplantation of human fetal neural stem cells (hNSCs) both locally at the injury site as well as distally via intrathecal injection would lead to improved functional recovery compared with controls. Study design/setting Twenty-four adult female Long-Evans hooded rats were randomized into four groups with six animals in each group: two experimental and two control. Functional assessment was measured after injury and then weekly for 6 weeks using the Basso, Beattie, and Bresnahan Locomotor Rating Score. Data were analyzed using two-sample t test and linear mixed-effects model analysis. Methods Posterior exposure and laminectomy at T10 level was used. Moderate spinal cord contusion was induced by the Multicenter Animal Spinal Cord Injury Study Impactor with 10-g weight dropped from a height of 25 mm. Experimental subjects received either a subdural injection of hNSCs locally at the injury site or intrathecal injection of hNSCs through a separate distal laminotomy. Controls received control media injection either locally or distally. Results Statistically significant functional improvement was observed in local or distal hNSCs subjects versus controls (p=.034 and 0.016, respectively). No significant difference was seen between local or distal hNSC subjects (p=.66). Conclusions Acute local and distal transplantation of hNSCs into the contused spinal cord led to significant functional recovery in the rat model. No statistical difference was found between the two techniques.

In brief Contrary to popular belief, sciatica, a symptom of lumbar disk herniation, is relatively uncommon. Characteristics include pain in the posterior thigh, lower leg, or foot that is greater than accompanying low-back pain. Sciatic tension tests confirm the presence of sciatica by reproducing the pain. Many patients who have sciatica recover spontaneously; most others can be treated conservatively with limitation of activity, anti-inflammatory medication, and gradual return to full activity. A variety of surgical options are available for patients who have extruded disks and progressive neurologic deficit or severe, persistent, intolerable pain.

To determine the presence of infectious microorganisms in the herniated discs of immunocompetent patients, using methodology that we hoped would be of higher sensitivity and specificity than has been reported in the past. Recent studies have demonstrated a significant rate of positive cultures for low virulent organisms in excised HNP samples (range 19–53%). These studies have served as the theoretical basis for a pilot trial, and then, a well done prospective randomized trial that demonstrated that systemic treatment with antibiotics may yield lasting improvements in a subset of patients with axial back pain. Whether the reported positive cultures in discectomy specimens represent true positives is as yet not proven, and critically important if underlying the basis of therapeutic approaches for chronic low back pain. This consecutive case series from a single academic center included 44 patients with radiculopathy and MRI findings of lumbar HNP. Patients elected for lumbar microdiscectomy after failure of conservative management. All patients received primary surgery at a single spinal level in the absence of immune compromise. Excised disc material was analyzed with a real-time PCR assay targeting the 16S ribosomal RNA gene followed by amplicon sequencing. No concurrent cultures were performed. Inclusion criteria were as follows: sensory or motor symptoms in a single lumbar nerve distribution; positive physical examination findings including positive straight leg raise test, distributional weakness, and/or a diminished deep tendon reflexes; and magnetic resonance imaging of the lumbar spine positive for HNP in a distribution correlating with the radicular complaint. The PCR assay for the 16S rRNA sequence was negative in all 44 patients (100%). 95% CI 0–8%. Based on the data presented here, there does not appear to be a significant underlying rate of bacterial disc infection in immunocompetent patients presenting with radiculopathy from disc herniation.

Study design A systematic review. Objectives The aim of this study is to evaluate the effectiveness of different types of surgery compared with different types of nonsurgical interventions in adults with symptomatic lumbar spinal stenosis (LSS). Summary of background data LSS is a debilitating condition associated with degeneration of the spine with aging. People with LSS experience a range of symptoms, including back pain, leg pain, numbness and tingling in the legs, and reduced physical function. Main treatment options are surgery, physical therapy, exercise, braces, and injections into the spine. Methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases, and two trials registries up to February 2015, reference lists, and conference proceedings related to treatment of the spine. Randomized controlled trials (RCTs) compared surgical versus nonoperative treatments in participants with LSS.Outcomes included quality of life, disability, function, pain, complication rates, and side effects. Results From the 12,966 citations screened, we included five RCTs (643 participants).Three studies compared spine surgery versus various types of nonsurgical treatment. It is difficult to draw conclusions from these studies because nonsurgical treatments were inadequately described. One study that compared surgery versus bracing and exercise found no differences in pain. Another study compared surgery versus spinal injections and found better physical function with injections, and better pain relief with surgery at six weeks. Still another trial compared surgery with an implanted device versus nonsurgical care. This study reported favorable outcomes of surgery for symptoms and physical function. Conclusion We cannot conclude on the basis of this review whether surgical or nonsurgical treatment is better for individuals with LSS. Nevertheless, we can report on the high rate of effects reported in three of five surgical groups, ranging from 10% to 24%. No side effects were reported for any of the conservative treatment options. Level of evidence 1.

Background Lumbar spinal stenosis (LSS) is a debilitating condition associated with degeneration of the spine with aging. Objectives To evaluate the effectiveness of different types of surgery compared with different types of non-surgical interventions in adults with symptomatic LSS. Primary outcomes included quality of life, disability, function and pain. Also, to consider complication rates and side effects, and to evaluate short-, intermediate- and long-term outcomes (six months, six months to two years, five years or longer). Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases and two trials registries up to February 2015. We also screened reference lists and conference proceedings related to treatment of the spine. Selection criteria Randomised controlled trials (RCTs) comparing surgical versus non-operative treatments in participants with lumbar spinal stenosis confirmed by clinical and imaging findings. Data collection and analysis For data collection and analysis, we followed methods guidelines of the Cochrane Back and Neck Review Group (Furlan 2009) and those provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Main results From the 12,966 citations screened, we assessed 26 full-text articles and included five RCTs (643 participants). Low-quality evidence from the meta-analysis performed on two trials using the Oswestry Disability Index (pain-related disability) to compare direct decompression with or without fusion versus multi-modal non-operative care showed no significant differences at six months (mean difference (MD) -3.66, 95% confidence interval (CI) -10.12 to 2.80) and at one year (MD -6.18, 95% CI -15.03 to 2.66). At 24 months, significant differences favoured decompression (MD -4.43, 95% CI -7.91 to -0.96). Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care (bracing and exercise) at three months (risk ratio (RR) 1.38, 95% CI 0.22 to 8.59), four years (RR 7.50, 95% CI 1.00 to 56.48) and 10 years (RR 4.09, 95% CI 0.95 to 17.58). Low-quality evidence from one small study suggested no differences at six weeks in the Oswestry Disability Index for patients treated with minimally invasive mild decompression versus those treated with epidural steroid injections (MD 5.70, 95% CI 0.57 to 10.83; 38 participants). Zurich Claudication Questionnaire (ZCQ) results were better for epidural injection at six weeks (MD -0.60, 95% CI -0.92 to -0.28), and visual analogue scale (VAS) improvements were better in the mild decompression group (MD 2.40, 95% CI 1.92 to 2.88). At 12 weeks, many cross-overs prevented further analysis. Low-quality evidence from a single study including 191 participants favoured the interspinous spacer versus usual conservative treatment at six weeks, six months and one year for symptom severity and physical function. All remaining studies reported complications associated with surgery and conservative side effects of treatment: Two studies reported no major complications in the surgical group, and the other study reported complications in 10% and 24% of participants, including spinous process fracture, coronary ischaemia, respiratory distress, haematoma, stroke, risk of reoperation and death due to pulmonary oedema. Authors' conclusions We have very little confidence to conclude whether surgical treatment or a conservative approach is better for lumbar spinal stenosis, and we can provide no new recommendations to guide clinical practice. However, it should be noted that the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. No clear benefits were observed with surgery versus non-surgical treatment. These findings suggest that clinicians should be very careful in informing patients about possible treatment options, especially given that conservative treatment options have resulted in no reported side effects. High-quality research is needed to compare surgical versus conservative care for individuals with lumbar spinal stenosis.

Background context Retrograde ejaculation (RE) is a complication of anterior lumbar interbody fusion (ALIF) techniques. Most commonly, this results from mechanical or inflammatory injury to the superior hypogastric plexus near the aortic bifurcation. Bone morphogenetic protein-2 (BMP-2) has been used in spinal fusions and has been associated with inflammatory and neuroinflammatory adverse reactions, which may contribute to RE development after anterior lumbar surgery. Purpose While controlling for anterior approach technique, we compared the incidence of RE with and without rhBMP-2 exposure, in large, matched cohorts of patients after ALIF. Study design Retrospective analysis of 10 years of prospectively gathered outcomes data on consecutive-patient cohorts having the same anterior exposure technique for ALIF with and without rhBMP-2 use. Patient sample All male patients without baseline sexual incapacity and having ALIF for lumbar spondylosis or spondylolisthesis of the lowest one or two lumbar levels with and without rhBMP-2, from 2002 through 2011. Outcome measures Diagnosis of RE as a new finding after ALIF compared against BMP-2 exposure, comorbid conditions, and other urological complications after ALIF surgery. Methods From the comprehensive surgical database at a high volume, university practice, male subjects having ALIF at one (L5/S1) or two levels (L4/5, L5/S1) from 2002 to 2011 were identified. Baseline comorbid factors, postoperative urinary catheter/retention events, and RE events were recorded and comparative incidence compared. Results There were four consecutive-patient cohorts identified: one before rhBMP-2 use was adopted (n=174), two cohorts in which BMP-2 use was routine (n=88 and n=151), and one final cohort after BMP-2 use was discontinued from routine use (n=59). The cohorts with and without BMP-2 exposure were closely comparable for age, approach, levels of surgery, comorbid factors affecting RE. Of 239 patients with ALIF and exposure to BMP-2, RE was diagnosed in 15 subjects (6.3%), compared with an RE diagnosis rate of two of 233 control patients without BMP-2 exposure (0.9%; p=.0012). Urinary retention after bladder catheter removal was also more frequently observed in patients exposed to BMP-2 (9.7%) compared with control patients (4.6%; p=.043). Of the baseline comorbid factors, medical or surgical treatment for prostatic hypertrophy disease was associated with an increased risk of RE in the BMP-2 patients (p=.034). Conclusions This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2 and an open anterior approach to the spine. This effect may be associated with an increased risk of postoperative urinary retention after BMP-2 exposure. The magnitude of the RE effect may be increased with concomitant prostatic disease treatments.

Background context Nonbattle illnesses and injuries are the major causes of unit attrition in modern warfare. Spine-area pain is a common disabling injury in service members associated with a very low return-to-duty (RTD) rate. Purpose To provide an overview of the current understanding of epidemiology, possible causes, and relative prognosis of spine-area pain syndromes in military personnel, including a discussion of various treatment options available in theaters of operation. Study design Literature review. Methods Search focusing on epidemiology, etiology and associative factors, and treatment of spinal pain using electronic databases, textbooks, bibliographic references, and personal accounts. Results Spine-area pain is the most common injury or complaint “in garrison” and appears to increase during training and combat deployments. Approximately three-quarters involve low back pain, followed by cervical and midback pain syndromes. Some predictive factors associated with spine-area pain are similar to those observed in civilian cohorts, such as psychosocial distress, heavy physical activity, and more sedentary lifestyle. Risk factors specific to military personnel include concomitant psychological trauma, g-force exposure in pilots and airmen, extreme shock and vibration exposure, heavy combat load requirements, and falls incurred during airborne, air assault, and urban dismounted ground operations. Effective forward-deployed treatment has been difficult to implement, but newer strategies may improve RTD rates. Conclusions Spine-area pain syndromes comprise a major source of unit attrition and are often the result of duty-related burdens incurred during combat operations. Current strategies in theaters of operation that may improve the low RTD rates include individual and unit level psychological support, early resumption of at least some forward-area duties, multimodal treatments, and ergonomic modifications.

Background Closed C2 fractures commonly occur after falls or other trauma in the elderly and are associated with significant morbidity and mortality. Controversy exists as to best treatment practices for these patients. Objective To compare outcomes for elderly patients with closed C2 fractures by treatment modality. Methods We retrospectively reviewed 28 surgically and 28 nonsurgically treated cases of closed C2 fractures without spinal cord injury in patients aged 65 years of age or older treated at Stanford Hospital between January 2000 and July 2010. Comorbidities, fracture characteristics, and treatment details were recorded; primary outcomes were 30-day mortality and complication rates; secondary outcomes were length of hospital stay and long-term survival. Results Surgically treated patients tended to have more severe fractures with larger displacement. Charlson comorbidity scores were similar in both groups. Thirty-day mortality was 3.6% in the surgical group and 7.1% in the nonsurgical group, and the 30-day complication rates were 17.9% and 25.0%, respectively; these differences were not statistically significant. Surgical patients had significantly longer lengths of hospital stay than nonsurgical patients (11.8 days vs 4.4 days). Long-term median survival was not significantly different between groups. Conclusion The 30-day mortality and complication rates in surgically and nonsurgically treated patients were comparable. Elderly patients faced relatively high morbidity and mortality regardless of treatment modality; thus, age alone does not appear to be a contraindication to surgical fixation of C2 fractures.

A single-center, prospective, consecutive case series of patients undergoing epidural lavage before the treatment of radiculopathy due to lumbar disc herniation.To determine whether a novel complex of fibronectin and aggrecan predicts clinical response to epidural steroid injection (ESI) for the indication of radiculopathy from lumbar herniated nucleus pulposus (HNP).ESI for lumbar radiculopathy due to HNP is widely used despite variable effectiveness for this indication. With increased attention aimed at cost containment, it would be beneficial to identify those in whom ESI may be helpful. There are currently no accurate diagnostic tests to predict response to ESI in back pain and sciatica syndromes. We have previously investigated biomarkers of disc degeneration associated with radiculopathy.We embarked to determine whether a molecular complex of fibronectin and aggrecan predicts clinical response to ESI for the indication of radiculopathy from HNP. This prospective study was conducted at a single center and included 26 patients with radiculopathic pain and magnetic resonance imaging positive for HNP, who elected ESI. Epidural lavage with physiologic saline was performed immediately before ESI. The lavage fluid was assayed for the fibronectin-aggrecan complex (FAC) by using a heterogeneous sandwich enzyme-linked immunosorbent assay. The results were compared with the interval improvement in the physical component summary (PCS) score of the Medical Outcomes Study Short Form-36 instrument (SF-36) after injection compared with baseline.The mean improvement from baseline PCS in patients with the FAC was 22.9 (SD, 12.4) and without the complex was 0.64 (SD, 3.97; P0.001). Differences in total SF-36 improvement were also highly significant (P0.001). The presence of the FAC predicts a clinically significant increase in PCS after lumbar ESI by receiver-operating-characteristic analysis (area under the curve = 0.97; P0.001). There was no significant difference in age (P = 0.25), sex (P = 0.84), laterality (P = 0.06), lumbar spinal level (P = 0.75), or payer type (worker's compensation vs. private insurance; P = 0.90) between groups with and without the marker.A molecular complex of fibronectin and aggrecan predicts response to lumbar ESI for radiculopathy with HNP. The biomarker is accurate, objective, and not affected by demographic or psychosocial variables in this series.

Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight.To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases.Systematic review.Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses.There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2-associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy.Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications.

Background Context The commercially available growth factor recombinant bone morphogenic protein-2 (rhBMP-2) used in spinal fusion has been associated with numerous adverse reactions, including inflammatory reactions in soft tissue, heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence. The original Food and Drug Administration Summary of anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejaculation (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. It had been debated whether this finding was related to rhBMP-2 use. Purpose To compare the incidence of RE after ALIF in patients with and without rhBMP-2 use. Study design Retrospective analysis of prospectively gathered outcomes data on consecutive subjects having ALIF with and without rhBMP-2 use. Patient sample Male patients with lumbar spondylosis or spondylolisthesis having ALIF of the lowest one or two lumbar levels with and without rhBMP-2. Outcome measure Report of RE as a new finding after ALIF. Methods From the comprehensive outcome database at a high-volume university practice, male subjects having ALIF for one- (L5/S1) or two-level (L4/L5, L5/S1) lumbar fusion were identified. Retrograde ejaculation events were recorded and comparative incidence compared. Results The two groups were comparable for age and additional procedures performed. There were 69 L5/S1 ALIFs performed with rhBMP-2 and 174 ALIFs performed without rhBMP-2 during the study period. Of those, 24 and 64 were two-level ALIFs performed with and without rhBMP-2, respectively. There were five RE events (7.2%) reported in the rhBMP-2 group and 1 (0.6%) in the control group. Comparing single-level L5/S1 ALIF, there was a 6.7% and 0% rate of RE in the rhBMP-2 versus control groups, respectively. At 1 year after surgery, three of six affected subjects reported resolution of the RE. Conclusion This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2. This may be an important consideration in subjects concerned with sterility after surgery.

A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors Eugene J. Carragee, MD*, Alexander J. Ghanayem, MD, Bradley K. Weiner, MD, David J. Rothman, PhD, Christopher M. Bono, MD Department of Orthopedic Surgery, Stanford University School of Medicine, 450 Broadway, Mail Code 6342, Redwood, CA 94063, USA Department of Orthopedic Surgery, Loyola University Medical Center, Maywood, IL, USA Department of Orthopedic Surgery, The Methodist Hospital, Houston, TX, USA Department of Social Medicine and Department of History, Columbia University College of Physicians and Surgeons, New York, NY, USA Department of Orthopedic Surgery, The Spine Journal, Brigham & Women’s Hospital, Boston, MA, USA Received 1 June 2011; accepted 1 June 2011

A case-control study with prospectively collected samples for laboratory analysis in a series of patients with spinal fragility fractures and a series of patients without fracture who underwent fusion for LBP.Was an exploratory data analysis for candidate cytokine biomarkers present in the fracture milieu of patients with persistent back pain associated with vertebral compression fracture.Lumbar and thoracic compression fractures are common. Little is known about the presence of inflammatory mediators within fractured vertebra in the clinical setting.Thirty patients diagnosed with a single thoracic or lumbar compression fracture were treated with single level vertebroplasty. At the time of intervention, needle aspiration was carried out at the fractured level. A multiplexed bead assay was used to assess the presence of 27 different cytokines and inflammatory mediators. A control group consisted of needle aspiration samples of 30 lumbar vertebra from 13 patients with chronic pain but no fracture undergoing open instrumented fusion.Thirty patients with 30 fractures consisted of 23 female and 7 male with a mean age of 77.5 years (SD 13.6; range 42 to 97) and a mean of 3.9 weeks of pain (SD 3.1; range 1 to 12). The highest levels of inflammatory mediators were (in order): IL-1 receptor antagonist, PDGF, RANTES, IP-10, IL-8, and eotaxin. These mediators were present at concentrations200 pg/mL. Compared with controls with chronic pain, significant differences were present for 4 mediators: TNF, MIP-1b, IL-9, and IL-12. The panel of these 4 markers was 93.3% specific and 66.7% sensitive for fracture compared with the control group.Inflammatory mediators are present in needle aspirates of symptomatic vertebral compression fractures. Some of these mediators show different levels than in patients with chronic pain but no fracture.Diagnostic level of evidence II.

BACKGROUND: Surgery for spinal metastasis is a palliative treatment aimed at improving patient quality of life by alleviating pain and reversing or delaying neurologic dysfunction, but with a mean survival time of less than 1 year and significant complication rates, appropriate patient selection is crucial. OBJECTIVE: To identify the most significant prognostic variables of survival after surgery for spinal metastasis. METHODS: Chart review was performed on 200 surgically treated spinal metastasis patients at Stanford Hospital between 1999 and 2009. Survival analysis was performed and variables entered into a Cox proportional hazards model to determine their significance. RESULTS: Median overall survival was 8.0 months, with a 30-day mortality rate of 3.0% and a 30-day complication rate of 34.0%. A Cox proportional hazards model showed radiosensitivity of the tumor (hazard ratio: 2.557, P < .001), preoperative ambulatory status (hazard ratio: 2.355, P = .0001), and Charlson Comorbidity Index (hazard ratio: 2.955, P < .01) to be significant predictors of survival. Breast cancer had the best prognosis (median survival, 27.1 months), whereas gastrointestinal tumors had the worst (median survival, 2.66 months). CONCLUSION: We identified the Charlson Comorbidity Index score as one of the strongest predictors of survival after surgery for spinal metastasis. We confirmed previous findings that radiosensitivity of the tumor and ambulatory status are significant predictors of survival.

Background context The use of antiplatelet agents after coronary artery stent placement is currently recommended to prevent coronary stent obstruction. These patients may have concurrent disabling spinal stenosis and require spinal decompression. Resuming antiplatelet agents as soon as possible after spinal surgery is recommended. Purpose To describe a unique case of late postoperative epidural hematoma occurring with the use of clopidogrel. Study design A case report and review of the literature. Methods The hospital chart, history, physical examination, and imaging of a single patient were reviewed. Results A 59-year-old man underwent spinal decompression and fusion for neurogenic claudication with lumbar spinal stenosis and spondylolisthesis while managed on clopidogrel for prevention of thrombosis after cardiac stent placement. He developed a symptomatic epidural hematoma 12 days postoperatively, well outside the usual time frame for this complication. The patient was closely monitored, and lumbar radiculopathy resolved over the ensuing days. Conclusion After spinal surgery and resumption of antiplatelet therapy, the physician needs to maintain vigilance in observing patients for late postoperative complications such as epidural hematoma, which could have catastrophic consequences if not recognized in a timely manner.

STUDY DESIGN Observational cohort study. SUMMARY OF BACKGROUND DATA Studies evaluating the treatment of presumed discogenic spine pain using nucleoplasty have reported variable success rates. It has been suggested that these procedures lower the intradiscal pressure, reduce disk protrusion, improve disk hydration, and restore disk height. It is proposed that such structural changes in treated disks correspond to the clinical improvement in patients. Radiographic and clinical evidence showing the efficacy of nucleoplasty remains inadequate. OBJECTIVE To document the comparative changes in magnetic resonance imaging (MRI) the appearance of disk morphology as reflected by Pfirrmann classification scores before and after the nucleoplasty treatment in patients with continued symptoms. METHODS Twenty-eight consecutive patients with persistent symptoms after nucleoplasty within 1 year of treatment were evaluated. Prenucleoplasty and postnucleoplasty MRIs were evaluated and Pfirrmann scores of the symptomatic level were determined. RESULTS In all the treated patients, comparison between the prenucleoplasty and the postnucleoplasty MRI of the targeted disks failed to show increased signal hydration, disk space height improvement, or shrinkage of the preoperative disk bulge at a mean time of 6 months after the procedure. Of the 17 cervical levels treated in 12 patients, 5 seemed to show progressive degeneration at treated levels (42% of the patients). Of the 17 lumbar procedures in 16 patients, 4 seemed to show progressive degeneration (25% of the patients) and 1 developed a new spondylolisthesis (6.3%). Thus, 32% of the patients in our cohort showed progressive degeneration at the treated level. The median Pfirrmann score in both prenucleoplasty and postnucleoplasty was 2, and the mean Pfirrmann classification prenucleoplasty and postnucleoplasty was 1.8 and 2.1, respectively (P

Background Context Defining success after spinal surgery remains problematic. The minimal clinically important difference (MCID) in pain or functional outcomes is a common metric often calculated independent of perceived risk and morbidity, which is an important consideration in large procedures such as spinal fusion and instrumentation. Purpose The purpose of this study was to describe a method of assessing treatment success based on prospective, patient-reported “minimum acceptable” outcome for which they would undergo a procedure. These goals can then be compared at follow-up to gauge how frequently patient goals are met and determine correlation with patient satisfaction. Study Design This is a clinical descriptive study of the patient-reported minimum acceptable outcomes for spinal fusion surgery. Outcome Measures Minimum acceptable outcomes were determined by patients on preoperatively administered standard questionnaires regarding ultimate pain intensity, functional outcome (Oswestry Disability Index [ODI]), medication usage, and work status. Satisfaction with outcomes was assessed at 2-year follow-up. Methods One hundred sixty-five consecutive patients undergoing lumbar fusion for either isthmic spondylolisthesis or disc degeneration were asked to preoperatively define on standard questionnaires their minimum acceptable outcomes after surgery. Two-year outcomes and satisfaction were subsequently reported and compared with the preoperatively determined minimum acceptable outcomes. Results Both the spondylolisthesis and the degenerative disc disease (DDD) groups reported that a high degree of improvement was the minimum acceptable threshold for considering spinal fusion. A large majority indicated that the minimum acceptable outcomes included at least a decrease in pain intensity to 3/10 or less, an improvement in ODI of 20 or more, discontinuing opioid medications, and return to some occupational activity. Achieving the minimum acceptable outcome was strongly associated with satisfaction at 2 years after surgery. Patients with compensation claims, psychological distress, and other psychosocial stressors were more likely to report satisfaction in the absence of achieving their minimum acceptable outcome. Conclusions Patients with spondylolisthesis and DDD both have relatively high minimum acceptable outcomes for spinal fusion. In these cohorts, few subjects considered more commonly proposed MCIDs for pain and function as an acceptable outcome and report that they would not have surgery if they did not expect to achieve more than those marginal improvements. Although there was good concordance between achieving the minimum acceptable outcomes and ultimate satisfaction, patients with significant psychosocial factors (compensation claims, psychological distress, and others) are less likely to associate satisfaction with outcomes with actually achieving these improvements.

Background context The pathophysiology underlying degenerative disc disease and its implication in painful syndromes remain unclear. However, spine magnetic resonance imaging (MRI) can demonstrate changes in disc water content and the annulus; provocative discography purportedly identifies degenerate discs causing serious low back pain; and biochemical assays have identified local inflammatory markers. No study to date has correlated pain on disc injection during discography evaluation with relevant MRI findings and biochemical markers. Purpose The purpose of this study was to correlate concordant pain on during discography to biochemical markers obtained by disc lavage and MRI findings. Study design This is a Phase 1 Diagnostic Test Assessment Cohort Study (Sackett and Haynes). Patient sample The patient sample included 21 symptomatic patients with suspected discogenic pain and three Phase 1 control subjects. Outcome measures The outcome measures included discography pain scores, MRI degenerative grades, and immunoreactivity to various inflammatory cytokine concentrations present in disc lavage samples. Methods Twenty-one symptomatic patients with lumbar degenerative disc disease and three control subjects underwent discography, MRI, and biochemical analysis of disc lavage fluid. Lumbar MRI was scored for Pfirrmann grading of the lumbar discs, and annular disruption was identified by nuclear disc lavage. Disc lavage samples were analyzed for biochemical markers by high-sensitivity immunoassay. Results Eighty-three discs from 24 patients were studied: 67 discs from 21 patients with axial back pain (suspected discogenic pain group) and 16 discs from 3 scoliosis patients without back pain (Phase 1 control subjects). Among the biochemical markers surveyed, interferon gamma (IFN-γ) immunoreactivity was most consistently identified in patients with axial back pain. Discs with annular disruption and concordant pain reproduction at a visual analog scale of 7 to 10/10 had greater IFN-γ immunoreactivity than those without this finding (p=.003); however, at least some IFN-γ immunoreactivity was found in all but one disc in the symptomatic group. Conclusions Among the potential inflammatory markers tested in this Phase 1 study, IFN-γ immunoreactivity was most commonly elevated in discogram “positive” discs but absent in asymptomatic controls. However, this marker was also frequently elevated in degenerative but “negative” discography discs. From these findings, Phase 2 and Phase 3 validity studies are reasonable to pursue. Phase 4 utility studies may be performed concurrently to assess this method's predictive value in outcome studies.

Pseudomorbidity in iliac crest bone graft harvesting: the rise of rhBMP-2 in short-segment posterior lumbar fusion Eugene J. Carragee, MD*, Christopher M. Bono, MD, Gaetano J. Scuderi, MD Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA 94305, USA Orthopedic Spine Service, Brigham and Women’s Hospital, Boston, MA 02478, USA Department of Orthopaedic Surgery, Stanford University Hospital and Clinics, Stanford, CA 94305, USA Received 1 September 2009; accepted 9 September 2009

Study Design. Prospective, match-cohort study of disc degeneration progression over 10 years with and without baseline discography. Objectives. To compare progression of common degenerative findings between lumbar discs injected 10 years earlier with those same disc levels in matched subjects not exposed to discography. Summary of Background Data. Experimental disc puncture in animal and in vivo studies have demonstrated accelerated disc degeneration. Whether intradiscal diagnostic or treatment procedures used in clinical practice causes any damage to the punctured discs over time is currently unknown. Methods. Seventy-five subjects without serious low back pain illness underwent a protocol MRI and an L3/4, L4/5, and L5/S1 discography examination in 1997. A matched group was enrolled at the same time and underwent the same protocol MRI examination. Subjects were followed for 10 years. At 7 to 10 years after baseline assessment, eligible discography and controlled subjects underwent another protocol MRI examination. MRI graders, blind to group designation, scored both groups for qualitative findings (Pfirrmann grade, herniations, endplate changes, and high intensity zone). Loss of disc height and loss of disc signal were measured by quantitative methods. Results. Well matched cohorts, including 50 discography subjects and 52 control subjects, were contacted and met eligibility criteria for follow-up evaluation. In all graded or measured parameters, discs that had been exposed to puncture and injection had greater progression of degenerative findings compared to control (noninjected) discs: progression of disc degeneration, 54 discs (35%) in the discography group compared to 21 (14%) in the control group (P = 0.03); 55 new disc herniations in the discography group compared to 22 in the control group (P = 0.0003). New disc herniations were disproportionately found on the side of the anular puncture (P = 0.0006). The quantitative measures of disc height and disc signal also showed significantly greater loss of disc height (P = 0.05) and signal intensity (P = 0.001) in the discography disc compared to the control disc. Conclusion. Modern discography techniques using small gauge needle and limited pressurization resulted in accelerated disc degeneration, disc herniation, loss of disc height and signal and the development of reactive endplate changes compared to match-controls. Careful consideration of risk and benefit should be used in recommending procedures involving disc injection.

Study Design. Prospective cohort study. Objective. We performed a prospective cohort study with standardized postoperative lumbar imaging every 3 months for a year then annually to assess the incidence and factors associated with same-level recurrent disc herniation. Summary of Background Data. The true incidence of same-level recurrent disc herniation after lumbar discectomy is unclear. Retrospective studies have reported widely varying incidences between 3% and 18%. Prospective controlled studies are lacking. Methods. A total of 108 patients undergoing first-time lumbar discectomy for refractory radiculopathy were enrolled. Baseline lumbar CT and MRI and standardized clinical data were assessed before surgery, and CT and MRI scans repeated 6 weeks, 3, 6, 9, 12, and 24-months after surgery and at the time of recurrent sciatica. Age, weight, preoperative disc volume, and height, volume of disc removed, and size of anular defect were compared with postoperative disc height loss and-recurrent disc herniation using regression analysis. Results. One hundred patients (41 ± 10 years old) were available for 1-year (93%) and 76 (70%) for 2-year follow-up (mean follow-up: 25 ± 12 months). Improvement in all outcome measures was observed by 6 weeks after surgery (P< 0.005). An 18% loss of disc height was observed 3 months after surgery, progressing to 26% by 2 years. Eleven (10.2%) patients experienced recurrent disc herniation requiring revision discectomy a mean 10.5 months after surgery. Subjects with larger anular defects (P = 0.019) and with smaller percentage of disc volume removed (P = 0.028) were associated with an increased risk of recurrent disc herniation. Conversely, those from whom greater disc volumes were removed (P = 0.024) had more progressive disc height loss by 6 months after surgery. Conclusion. Larger anular defects and less disc removal increased the risk of reherniation. Greater volumes of disc removal were associated with accelerated disc height loss. In the setting of larger anular defects or less aggressive disc removal, concern for recurrent herniation should be increased during outpatient follow-up. In this situation effective anular repair may be helpful.

Objective To determine whether posterior lumbar disk contour dimensions differ in the flexed seated, upright seated, and extended seated positions. Design Two subgroups of subjects with degenerative disk disease were compared: those with central posterior disk bulge (at L4-5 or L5-S1 levels) and those with a dark nucleus pulposus without posterior disk bulge (L3-4, L4-5, and/or L5-S1 levels). Setting Academic medical center. Participants Eight subjects with a central disk bulge and 9 subjects with a dark nucleus pulposus on magnetic resonance imaging. Interventions Not applicable. Main Outcome Measures Quantitative comparisons of posterior disk contour between neutral, flexed, and extended sitting positions. Results Of 8 subjects with central disk bulge, spinal flexion (from the neutral position) produced a decreased disk contour in all subjects, whereas spinal extension (from the neutral position) produced an increased disk contour in 6 subjects, a decreased disk contour in 1 subject, and no measurable change in 1 subject. Changes in posterior disk contour in subjects with a dark nucleus pulposus were variable. Approximately half increased and half decreased, but no relation to position was determined. Conclusions The results of this pilot study suggest a consistent pattern of decreased posterior disk contour with spinal flexion and increased posterior disk contour with spinal extension in subjects with central disk bulge, but not in those with a dark nucleus pulposus.

Study design: Systematic review. Objective: To systematically assess benefits and harms of surgery for nonradicular back pain with common degenerative changes, radiculopathy with herniated lumbar disc, and symptomatic spinal stenosis. Summary of background data: Although back surgery rates continue to increase, there is uncertainty or controversy about utility of back surgery for various conditions. Methods: Electronic database searches on Ovid MEDLINE and the Cochrane databases were conducted through July 2008 to identify randomized controlled trials and systematic reviews of the above therapies. All relevant studies were methodologically assessed by 2 independent reviewers using criteria developed by the Cochrane Back Review Group (for trials) and Oxman (for systematic reviews). A qualitative synthesis of results was performed using methods adapted from the US Preventive Services Task Force. Results: For nonradicular low back pain with common degenerative changes, we found fair evidence that fusion is no better than intensive rehabilitation with a cognitive-behavioral emphasis for improvement in pain or function, but slightly to moderately superior to standard (nonintensive) nonsurgical therapy. Less than half of patients experience optimal outcomes (defined as no more than sporadic pain, slight restriction of function, and occasional analgesics) following fusion. Clinical benefits of instrumented versus noninstrumented fusion are unclear. For radiculopathy with herniated lumbar disc, we found good evidence that standard open discectomy and microdiscectomy are moderately superior to nonsurgical therapy for improvement in pain and function through 2 to 3 months. For symptomatic spinal stenosis with or without degenerative spondylolisthesis, we found good evidence that decompressive surgery is moderately superior to nonsurgical therapy through 1 to 2 years. For both conditions, patients on average experience improvement either with or without surgery, and benefits associated with surgery decrease with long-term follow-up in some trials. Although there is fair evidence that artificial disc replacement is similarly effective compared to fusion for single level degenerative disc disease and that an interspinous spacer device is superior to nonsurgical therapy for 1- or 2-level spinal stenosis with symptoms relieved with forward flexion, insufficient evidence exists to judge long-term benefits or harms. Conclusion: Surgery for radiculopathy with herniated lumbar disc and symptomatic spinal stenosis is associated with short-term benefits compared to nonsurgical therapy, though benefits diminish with long-term follow-up in some trials. For nonradicular back pain with common degenerative changes, fusion is no more effective than intensive rehabilitation, but associated with small to moderate benefits compared to standard nonsurgical therapy.

Study Design Best evidence synthesis. Objective To undertake a best evidence synthesis on the burden and determinants of whiplash-associated disorders (WAD) after traffic collisions. Summary of Background Data Previous best evidence synthesis on WAD has noted a lack of evidence regarding incidence of and risk factors for WAD. Therefore there was a warrant of a reanalyze of this body of research. Methods A systematic search of Medline was conducted. The reviewers looked for studies on neck pain and its associated disorders published 1980–2006. Each relevant study was independently and critically reviewed by rotating pairs of reviewers. Data from studies judged to have acceptable internal validity (scientifically admissible) were abstracted into evidence tables, and provide the body of the best evidence synthesis. Results The authors found 32 scientifically admissible studies related to the burden and determinants of WAD. In the Western world, visits to emergency rooms due to WAD have increased over the past 30 years. The annual cumulative incidence of WAD differed substantially between countries. They found that occupant seat position and collision impact direction were associated with WAD in one study. Eliminating insurance payments for pain and suffering were associated with a lower incidence of WAD injury claims in one study. Younger ages and being a female were both associated with filing claims or seeking care for WAD, although the evidence is not consistent. Preliminary evidence suggested that headrests/car seats, aimed to limiting head extension during rear-end collisions had a preventive effect on reporting WAD, especially in females. Conclusion WAD after traffic collisions affects many people. Despite many years of research, the evidence regarding risk factors for WAD is sparse but seems to include personal, societal, and environmental factors. More research including, well-defined studies with accurate denominators for calculating risk, and better consideration of confounding factors, are needed.

Study Design Best evidence synthesis. Objective To identify, critically appraise, and synthesize literature from 1980 through 2006 on noninvasive interventions for neck pain and its associated disorders. Summary of Background Data No comprehensive systematic literature reviews have been published on interventions for neck pain and its associated disorders in the past decade. Methods We systematically searched Medline and screened for relevance literature published from 1980 through 2006 on the use, effectiveness, and safety of noninvasive interventions for neck pain and associated disorders. Consensus decisions were made about the scientific merit of each article; those judged to have adequate internal validity were included in our best evidence synthesis. Results Of the 359 invasive and noninvasive intervention articles deemed relevant, 170 (47%) were accepted as scientifically admissible, and 139 of these related to noninvasive interventions (including health care utilization, costs, and safety). For whiplash-associated disorders, there is evidence that educational videos, mobilization, and exercises appear more beneficial than usual care or physical modalities. For other neck pain, the evidence suggests that manual and supervised exercise interventions, low-level laser therapy, and perhaps acupuncture are more effective than no treatment, sham, or alternative interventions; however, none of the active treatments was clearly superior to any other in either the short- or long-term. For both whiplash-associated disorders and other neck pain without radicular symptoms, interventions that focused on regaining function as soon as possible are relatively more effective than interventions that do not have such a focus. Conclusion Our best evidence synthesis suggests that therapies involving manual therapy and exercise are more effective than alternative strategies for patients with neck pain; this was also true of therapies which include educational interventions addressing self-efficacy. Future efforts should focus on the study of noninvasive interventions for patients with radicular symptoms and on the design and evaluation of neck pain prevention strategies.

Study Design Best evidence synthesis. Objective To identify, critically appraise, and synthesize literature from 1980 through 2006 on surgical interventions for neck pain alone or with radicular pain in the absence of serious pathologic disease. Summary of Background Data There have been no comprehensive systematic literature or evidence-based reviews published on this topic. Methods We systematically searched Medline for literature published from 1980 to 2006 on percutaneous and open surgical interventions for neck pain. Publications on the topic were also solicited from experts in the field. Consensus decisions were made about the scientific merit of each article; those judged to have adequate internal validity were included in our Best Evidence Synthesis. Results Of the 31,878 articles screened, 1203 studies were relevant to the Neck Pain Task Force mandate and of these, 31 regarding treatment by surgery or injections were accepted as scientifically admissible. Radiofrequency neurotomy, cervical facet injections, cervical fusion and cervical arthroplasty for neck pain without radiculopathy are not supported by current evidence. We found there is support for short-term symptomatic improvement of radicular symptoms with epidural corticosteroids. It is not clear from the evidence that long-term outcomes are improved with the surgical treatment of cervical radiculopathy compared to nonoperative measures. However, relatively rapid and substantial symptomatic relief after surgical treatment seems to be reliably achieved. It is not evident that one open surgical technique is clearly superior to others for radiculopathy. Cervical foramenal or epidural injections are associated with relatively frequent minor adverse events (5%–20%); however, serious adverse events are very uncommon ( Conclusion Surgical treatment and limited injection procedures for cervical radicular symptoms may be reasonably considered in patients with severe impairments. Percutaneous and open surgical treatment for neck pain alone, without radicular symptoms or clear serious pathology, seems to lack scientific support.

Study Design Best evidence synthesis. Objective To critically appraise and synthesize the literature on assessment of neck pain. Summary of Background Data The published literature on assessment of neck pain is large and of variable quality. There have been no prior systematic reviews of this literature. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders conducted a critical review of the literature (published 1980–2006) on assessment tools and screening protocols for traumatic and nontraumatic neck pain. Results We found 359 articles on assessment of neck pain. After critical review, 95 (35%) were judged scientifically admissible. Screening protocols have high predictive values to detect cervical spine fracture in alert, low-risk patients seeking emergency care after blunt neck trauma. Computerized tomography (CT) scans had better validity (in adults and elderly) than radiographs in assessing high-risk and/or multi-injured blunt trauma neck patients. In the absence of serious pathology, clinical physical examinations are more predictive at excluding than confirming structural lesions causing neurologic compression. One exception is the manual provocation test for cervical radiculopathy, which has high positive predictive value. There was no evidence that specific MRI findings are associated with neck pain, cervicogenic headache, or whiplash exposure. No evidence supports using cervical provocative discography, anesthetic facet, or medial branch blocks in evaluating neck pain. Reliable and valid self-report questionnaires are useful in assessing pain, function, disability, and psychosocial status in individuals with neck pain. Conclusion The scientific evidence supports screening protocols in emergency care for low-risk patients; and CT-scans for high-risk patients with blunt trauma to the neck. In nonemergency neck pain without radiculopathy, the validity of most commonly used objective tests is lacking. There is support for subjective self-report assessment in monitoring patients' course, response to treatment, and in clinical research.

Study Design Best evidence synthesis. Objective To undertake a best evidence synthesis of the published evidence on the burden and determinants of neck pain and its associated disorders in the general population. Summary of Background Data The evidence on burden and determinants of neck has not previously been summarized. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders performed a systematic search and critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We identified 469 studies on burden and determinants of neck pain, and judged 249 to be scientifically admissible; 101 articles related to the burden and determinants of neck pain in the general population. Incidence ranged from 0.055 per 1000 person years (disc herniation with radiculopathy) to 213 per 1000 persons (self-reported neck pain). Incidence of neck injuries during competitive sports ranged from 0.02 to 21 per 1000 exposures. The 12-month prevalence of pain typically ranged between 30% and 50%; the 12-month prevalence of activity-limiting pain was 1.7% to 11.5%. Neck pain was more prevalent among women and prevalence peaked in middle age. Risk factors for neck pain included genetics, poor psychological health, and exposure to tobacco. Disc degeneration was not identified as a risk factor. The use of sporting gear (helmets, face shields) to prevent other types of injury was not associated with increased neck injuries in bicycling, hockey, or skiing. Conclusion Neck pain is common. Nonmodifiable risk factors for neck pain included age, gender, and genetics. Modifiable factors included smoking, exposure to tobacco, and psychological health. Disc degeneration was not identified as a risk factor. Future research should concentrate on longitudinal designs exploring preventive strategies and modifiable risk factors for neck pain.

Study Design Best-evidence synthesis. Objective To perform a best evidence synthesis on the course and prognostic factors for neck pain and its associated disorders in workers. Summary of Background Data Knowledge of the course of neck pain in workers guides expectations for recovery. Identifying prognostic factors assists in planning effective workplace policies, formulating interventions and promoting lifestyle changes to decrease the frequency and burden of neck pain in the workplace. Methods The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We found 226 articles related to course and prognostic factors in neck pain and its associated disorders. After a critical review, 70 (31%) were accepted on scientific merit; 14 of these studies related to course and prognostic factors in working populations. Between 60% and 80% of workers with neck pain reported neck pain 1 year later. Few workplace or physical job demands were identified as being linked to recovery from neck pain. However, workers with little influence on their own work situation had a slightly poorer prognosis, and white-collar workers had a better prognosis than blue-collar workers. General exercise was associated with better prognosis; prior neck pain and prior sick leave were associated with poorer prognosis. Conclusion The Neck Pain Task Force presents a report of current best evidence on course and prognosis for neck pain. Few modifiable prognostic factors were identified; however, having some influence over one's own job and being physically active seem to hold promise as prognostic factors.

Study Design Best evidence synthesis. Objective To report on gaps in the literature and make methodologic recommendations based on our review of the literature on frequency and risk factors, assessment, intervention, and course and prognostic factors for neck pain and its associated disorders. Summary of Background Data The scientific literature on neck pain is large and of variable quality. We reviewed 1203 studies and judged 46% to be of sufficient scientific validity to be included in the best evidence synthesis. Scientific quality varied across study topics, and fundamental questions remain about important issues. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We outline a large number of gaps in the current literature. For example, we found important gaps in our knowledge about neck pain in children (risk factors, screening criteria to rule out serious injury, management, course and prognosis); and in the prevention of neck pain-related activity limitations. Few studies addressed the impact of culture or social policies (such as governmental health policies or insurance compensation policies) on neck pain. A number of important questions remain about the effectiveness of commonly used interventions for neck pain. Conclusion The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for whiplash-associated disorders. We identify a number of gaps in the current knowledge, and provide recommendations for the conduct of future studies.