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“Surgery for Low Back Pain:
A Review of the Evidence from the American Pain Society Clinical Practice Guidelines”
Robert Chou, M.D.
Spine, 2009; 34: 1094-1109
The authors assessed the benefits and harms of surgery for non-radicular back pain with common degenerative changes, radiculopathy and herniated lumbar disc, and symptomatic spinal stenosis.
They note that the rates of back surgery in the U.S. are the highest in the world and continue to rise steadily. Common back surgeries include fusion for non-radicular low back pain with degenerative changes, and most frequently degenerative disc disease with presumed discogenic back pain, discectomy for radiculopathy with herniated lumbar disc, and decompressive laminectomy with or without fusion for a symptomatic spinal stenosis, with or without degenerative spondylolisthesis. They further note that other surgical techniques, including artificial disc replacement as an alternative to fusion and interspinous spacer device as an alternative to decompressive laminectomy were also studied. They conclude that for non-radicular low back pain with common degenerative changes, there is fair evidence from randomized trials that fusion is no more effective than intensive rehabilitation with a cognitive behavioral emphasis, but slightly to moderately more effective than standard non-intensive non-surgical therapy for improvement of pain and function.
For radiculopathy with herniated lumbar disc, they conclude that there is good evidence that open discectomy and microdiscectomy are moderately superior to non-surgical therapy for improvement of pain and function for 2-3 months, but evidence on longer-term benefits is inconsistent.
The authors make further recommendations for spinal stenosis with and without degenerative spondylolisthesis and find good evidence that compressive laminectomy with and without fusion is moderately superior to non-surgical therapy for improvement in pain and function for 1-2 years.
The authors further conclude that there is fair evidence that artificial disc replacement is as effective as fusion for non-radicular low back pain with single level degenerative disc disease and that an interspinous spacer device is moderately more effective than non-surgical therapy for 1-2 level spinal stenosis. However, there is insufficient data to assess long-term benefits and harms.
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“Non-surgical interventional therapies
for low back pain.
I reviewed the evidence from the American Pain Society Clinical Practice Guidelines.”
Roger Chou, et. al
Spine, 2009; 34: 1078-1093
The authors studied a wide range of interventional therapies. They concluded that for sciatica or prolapsed lumbar disc with radiculopathy, they found good evidence that chemonucleolysis is moderately superior to placebo injections but inferior to surgery, and fair evidence that epidural steroid injection is moderately effective for short-term but not long-term symptom relief. They found fair evidence that spinal cord stimulation is moderately effective at failed back surgery syndrome with persistent radiculopathy, although device-related complications are common. They also found good or fair evidence that prolotherapy, facet joint injections, interdiscal steroid injections, and radiofrequency thermocoagulation were not effective. Insufficient evidence exists to reliably evaluate other interventional therapies.
They further concluded that there are few non-surgical interventional therapies for low back pain that have been shown to be effective in randomized placebo controlled trials.
They found insufficient or poor evidence from randomized controlled trials to reliably evaluate other interventional therapies, including local injctions, botulinum toxin injection, therapeutic medial branch block, sacroiliac joint injections, radiofrequency denervation, IDET, and coblation nucleoplasty.
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“Interventional Therapies, Surgery &
Interdisciplinary Rehabilitation for Low Back Pain:
An Evidence-Based Clinical Practice Guidelines
from the American Pain Society”
Robert Roger Chou, et. al
Spine, 2009, 34: 1066-1067
The authors set out to develop evidence-based recommendations on the use of interventional diagnostic tests and therapies, surgeries, and interdisciplinary rehabilitation for low back pain of any duration, with or without leg pain. They acknowledge that management of patients with persistent disabling low back pain is a clinical challenge. They note the utility of some of the interventional diagnostic testing and therapies including surgery, and although their use is increasing, the utility remains uncertain or controversial. They point out that interventional or surgical therapies do not address the psychological and environmental factors that are associated with chronic low back pain. They also note that interdisciplinary rehabilitation does not target a specific anatomic source of back pain but incorporates psychological interventions and exercise therapy and could be viewed as an alternative treatment option for persistent disabling low back pain.
13 authors of this paper are noted, and they reviewed 3,348 abstracts. The objective of this study was to present evidence-based recommendations for the use of invasive diagnostic tests, interventional therapies, surgery, and interdisciplinary rehabilitation for non-radicular low back pain, radiculopathy with herniated disc, and symptomatic spinal stenosis. This large group of distinguished spine care professionals concluded that provocative discography is not recommended because its diagnostic accuracy remains uncertain, false positives can occur in persons without low back pain, and its use has not been shown to improve clinical outcomes. They recommended interdisciplinary rehabilitation be considered as a treatment option for persistent, disabling low back pain that does not respond to usual, non-interdisciplinary therapies.
They also recommended that for persistent non-radicular low back pain, facet joint corticosteroid injection, prolotherapy, and interdiscal corticosteroid injections are not recommended and there is insufficient evidence to reliably guide recommendations on use of other interventional therapies. They also concluded that a shared decision making process includes a detailed
discussion of risks, moderate to average benefits, and treatment alternatives to be recommended to guide decisions regarding surgery.
The authors also made recommendations regarding radicular low back pain in that a shared decision making process, including a detailed discussion of risks and inconsistent evidence regarding short-term benefits be recommended to guide decisions regarding epidural steroid injections. They also recommended shared decision making to guide decisions regarding surgery for spinal stenosis and prolapsed lumbar disc, although supporting evidence was stronger than for surgery for non-radicular low back pain. They recommended that in patients with persistent pain following surgery for herniated disc that shared decision making process includes a detailed discussion of risks, including frequent device-related complications and benefit be recommended to guide decisions regarding spinal cord stimulation.
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Reassessment of Clinical Practice Guidelines
Shaneyfelt and Centor
JAMA, February 25, 2009 – volume 301, #8, 868-869
This is an editorial which the authors discussed the current state of clinical practice guidelines. They state that too many current guidelines have become marketing and opinion-based pieces, delivering directive rather than assistive statements. They did note that in 1990, the Institute of Medicine proposed guideline development to reduce inappropriate healthcare variation by assisting patient and practitioner decisions.
The authors feel that current use of the term guidelines have strayed far from the original intent of the Institute of Medicine and the current guidelines that are in use are basically expert consensus reports. The authors point out that the over-reliance on expert opinion and guidelines is problematic. All guideline committees begin with implicit biases and values which affects the recommendations they make. Bias may occur subconsciously and therefore go unrecognized. Converting data into recommendations require subjective judgement; the value structure of the panel members molds those judgements. Guideline consumers can adjust for these biases if guideline panels made their values and goals explicit but usually they are made opaque.
The authors express an opinion that the most widely recognized bias is financial. They state that guidelines often will become marketing tools for device and pharmaceutical manufacturers. The authors go further and state that financial ties between guideline panel members and industry are common.
They feel that guidelines are often too narrowly focused on single diseases and not patient focused. They bring out the point that patients seldom have single diseases and few if any guidelines help clinicians in managing complexity. Paradoxically, guidelines are often too comprehensive, covering every possible intervention that could be appropriate for a patient with that single disease. They further add that most guidelines have one size fits all mentality and do not build flexibility or contextualization into the recommendations. They state that there are too many guidelines often in the same topic. They find that guidelines become outdated after five years and most guidelines developers lack formal procedures for updating their guidelines.
They express greater concern that some of these consensus statements are being turned into performance measures and other tools to critique the quality of physical care. They find that this potential problem could be minimized and performance measures were derived from high quality guidelines based on the highest level of evidence and applied to patients with a single disease requiring little clinical judgement and not attention to patient preferences. The authors find that these patients require collaborative efforts to balance each patient’s overall health status with the burdens, risks, and benefits of complex care, something single disease guidelines and their resultant quality indicators do not address.
The authors recommend that the time has come for guideline development to again be centralized, under the guidance of the agency for healthcare research and quality or a group similar to the U.S. Preventative Service Task Force. Such centralization should help reduce bias and redundancy and better guide the research agenda. The U.S. Department of Health and Human Services seems best suited to fund guideline endeavors. They recommend that guidelines should develop flexibility and that guidelines are supposed to be guides and not rules and one size certainly does not fit for all patients. Recommendations should vary based on patient comorbidities, the healthcare setting in patient values and preferences. Their flexibility is to be taken seriously, the nearly anatomic translation of guidelines into performance measures would require renewed attention.
The editorial makes a final plea that unless there is evidence of appropriate changes in the guideline process, clinicians and policy makers must reject calls for adherence to guidelines. Physicians would be better off making clinical decisions based on valid primary data.
The authors make reference to the ACC/AHA Clinical Practice Guidelines (American College of Cardiology and the American Heart Association). The editors appear to imply that the guidelines also apply to other fields of specialties as well and not just cardiology. This appears a statement that applies in general to the practice of medicine.
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Preventative Strategies and Tactics of Work Related Disorders
(Occupational Medicine Practice Guidelines, Second Edition,
published by the American College of Occupational and Environmental Medicine,
2008 Revision, pages 4-11)
These guidelines state that primary prevention is preferable to second and tertiary prevention. The authors further clarify primary prevention of work related disorders and this would depend on the reduction or elimination of exposure to factors causally related with those disorders in individuals susceptible to such stressors. In the past, emphasis has been placed on risk factors that are physical in nature such as force, repetition, posture vibration, lighting, terminal design and posture. The guidelines note that other factors such as work or job satisfaction and relations with co-workers and supervisors have been specifically noted to have a relatively strong relationship to musculoskeletal, visual and other apparently ergonomic complaints. They emphasize that primary preventions of work related complaints thus depends on reducing exposure to physical, personal, and psychosocial stressors. As an example, the guidelines state that engineering controls, including ergonomic workstation evaluation and modification, and job redesign to accommodate a reasonable proportion of the workforce may well be the most cost effective measure in the long run. Personal protective equipment can also be an effective strategy for primary prevention. Primary prevention strategies based on maintaining activity and flexibility, such as exercise breaks for workers performing assembly tasks or a scheduled rotation of tasks, appears to be low in cost and generally effective based on physiologic principles. Strategies that improve work organization and management designs should also be addressed.
Included in primary prevention includes work design, ergonomic tactics to prevent upper body musculoskeletal complaints and disorders, ergonomic tactics to prevent visual fatigue and other visual disorders, personal risk modification and preplacement and periodic examinations. They state that the preplacement examination process will determine whether the employee is capable of performing in a safe manner the tasks identified in the job task analysis.
They also include physical hazard control including engineering controls, administrative controls and personal protective equipment, management education, employee education and involvement as well.
Secondary prevention consists of detection and surveillance programs designed to identify early indicators of difficulties such as symptoms, minor injuries, sprains and strains, with intervention to avoid re-injury and/or the worsening of conditions including iatrogenic disability. Secondary prevention is aimed at reducing disability and hastening recovery once a health concern has become apparent. This is a more targeted approach in that it has become apparent which workers will develop complaints, illnesses or injuries. Secondary prevention involves working in partnership with the worker, and the cornerstones of this process are two-way communication, addressing myths and misconceptions, management of expectations, bilateral or trilateral planning and management of these episodes and situations. They note the importance of returning workers to the worksite and to prevent social isolation and deconditioning.
They state that surveillance systems for the detection of work related health complaints that may cause discomfort, develop into fixed pathology or impair productivity are recommended as well. They state that the components of an occupational surveillance program include detection and enumeration of job related morbidity and mortality, characterization of trans identifications of new patterns or clusters of disease, and monitoring of interventions to decrease frequency or severity.
They define tertiary prevention as vocational rehabilitation and functional restoration of a worker who has a major alteration in work capacity or life whether due to major biologic event such as a catastrophic injury or severe disease. Tertiary prevention in the work setting involves prevention of recurrences in a pattern which has had a previous episode. They recommend that the job should be evaluated or an evaluation of the tasks in the person – job fit and modify the job tasks or workstation as necessary.
They emphasize that reconditioning and avoidance of static positions for long periods of time should help to prevent recurrences. Both aerobic conditioning and conditioning of specific muscle groups such as forearm muscles or neck and shoulder musculature should reduce the risk of future health problems.
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