A study published by the American Journal of Obstetrics and Gynecology, demonstrates that osteopathic manipulative treatment slows or halts the deterioration of back-specific function in the third trimester of pregnancy.
The Phase II randomized clinical trial of 144 subjects showed that women in the usual obstetric care and osteopathic manipulative treatment group reported less deterioration of back-specific function on the Roland-Morris Disability Scale than women in the usual obstetric care and sham ultrasound and the usual obstetric care only groups when these groups were compared using an intention-to-treat analysis. This study is the first randomized, placebo-controlled trial to explore the potential effects of osteopathic manipulative treatment during the third trimester of pregnancy.
In the study, conducted by The Osteopathic Research Center in conjunction with the Department of Obstetrics and Gynecology at the University of North Texas Health Science Center in Fort Worth, Texas, women were enrolled between the 28th and 30th week of pregnancy. After being randomized to one of the three treatment groups, the women in the usual obstetric care and osteopathic manipulative treatment and usual obstetric care and sham ultrasound groups received treatments immediately following each of their third trimester prenatal visits. Women were excluded from or dropped from the study if they were determined to be at high risk by their obstetrician. The median age for women included in the study was 24 years.
Usual obstetric care was defined in this study as the conventional prenatal care received during pregnancy. Osteopathic manipulative treatment is generally considered a complementary treatment that is not included as part of routine prenatal care.
Osteopathic manipulative treatment is a system of hands-on diagnosis and treatment that is used to reduce pain, restore range of motion and to restore normal function and balance in the body.
“This study is exciting because pregnant women frequently experience a negative impact on their ability to function and perform tasks related to daily living as their pregnancy progresses,” said John Licciardone, D.O., M.S., M.B.A., the principal investigator for the project, and the executive director of The Osteopathic Research Center. “Since pregnant women are limited in the medications they can take for pain, osteopathic manipulative treatment offers a way to improve back function and decrease pain in the third trimester of pregnancy, when a majority of women experience these symptoms.”
“What is also interesting about this study is that osteopathic physicians (D.O.s) who provide obstetrical care can potentially include osteopathic manipulative treatment as part of their prenatal care for patients,” Licciardone said. “For more than 100 years, osteopathic physicians who have treated pregnant women using osteopathic manipulation have claimed that their patients have less pain, better function and improved delivery outcomes. This study may be the first step in confirming the clinical success of osteopathic physicians in this area of medicine.”
Full text of the article is available online at http://www.ajog.org/inpress.
Friday, September 25, 2009
Wednesday, May 13, 2009
New Guideline for Low-Back Pain Interventions, Surgery
The American Pain Society (APS) has issued a new clinical practice guideline for low back pain that emphasizes the use of noninvasive treatments over interventional procedures, as well as shared decision making between provider and patient. The findings are published in the current (May 1, 2009) issue of the journal Spine.
The new APS guideline, based on an extensive review of existing research, provides clinicians with eight recommendations to help determine the best way to treat patients with low-back pain. It also expands its current and previously published guideline for initial evaluation and management of this chronic condition.
“These recommendations are based on an even more complete body of evidence than was available just a few years ago. Consequently, we believe these recommendations will give physicians more confidence when treating patients with persistent back pain,” said Roger Chou, M.D., lead author, director of the APS Clinical Practice Guideline Program, and associate professor of medicine (general internal medicine), Oregon Evidence-based Practice Center, Oregon Health & Science University.
“Unfortunately, randomized trials for a number of commonly used interventional procedures are still too limited to generate evidence-based recommendations, and our review also highlights the need for more research,” Chou added.
Low-back pain is the fifth most common reason for doctor’s visits and accounts for more than $26 billion in direct health care costs nationwide each year. While a number of interventional diagnostic tests and therapies, and surgery are available, and their use is increasing, in some cases their usefulness remains uncertain.
“We have advocated strongly in many of our recommendations for physicians to use shared decision making because of the relatively close trade-offs between potential benefits relative to harms, as well as costs and burdens of these various treatment options,” Chou explained. Shared decision making involves a patient’s full participation in medical choices after receiving comprehensive information about the impact of all options on his or her particular life situation.
To develop the guideline, a multidisciplinary APS panel, augmented by experts on interventional therapies, reviewed 3,348 abstracts and analyzed 161 relevant clinical trials. The panel found that the evidence for the use of these interventions was mixed, sparse or not available. Based on the data the panel gathered, the APS now recommends:
1. Against the use of provocative discography (injection of fluid into the disc in order to determine if it is the source of back pain) for patients with chronic nonradicular low-back pain.
2. The consideration of intensive interdisciplinary rehabilitation with a cognitive/behavioral emphasis for patients with nonradicular low-back pain who do not respond to usual, non-interdisciplinary therapies.
3. Against facet joint corticosteroid injection, prolotherapy, and intradiscal corticosteroid injections for patients with persistent nonradicular low-back pain, and insufficient evidence to guide use of other interventional therapies.
4. A discussion of risks and benefits of surgery and the use of shared decision making with reference to rehabilitation as a similarly effective option for patients with nonradicular low-back pain, common degenerative spinal changes, and persistent and disabling symptoms.
5. Insufficient evidence to guide recommendations for vertebral disc replacement.
6. A discussion of the risks and benefits of epidural steroid injections and shared decision making, including specific review of evidence of lack of long-term benefit for patients with persistent radiculopathy due to herniated lumbar disc.
7. A discussion of the risks and benefits of surgery and use of shared decision making that references moderate benefits that decrease over time for patients with persistent and disabling radiculopathy due to herniated lumbar disc or persistent and disabling leg pain.
8. Discussion of risks and benefits of spinal cord stimulation and shared decision making, including reference to the high rate of complications following stimulator placement for patients with persistent and disabling radicular pain following surgery for herniated disc and no evidence of a persistently compressed nerve root.
Chou and his colleagues also reaffirm their previous recommendation that all low-back pain patients stay active and talk honestly with their physicians about self care and other interventions. “In general, noninvasive therapies supported by evidence showing benefits should be tried before considering interventional therapies or surgery,” said Chou.
Recommendations from the first APS Clinical Practice Guideline on Low-Back Pain are intended for primary care physicians and appeared in the Oct, 2, 2007, issue of the Annals of Internal Medicine. For diagnosis, the first APS low-back pain guideline advises clinicians to minimize routine use of X-rays or other diagnostic tests except for patients known or believed to have underlying neurological or spinal disorders
About the American Pain Society
Based in Glenview, Ill., the American Pain Society (APS) is a multidisciplinary community that brings together a diverse group of scientists, clinicians and other professionals to increase the knowledge of pain and transform public policy and clinical practice to reduce pain-related suffering.APS was founded in 1978 with 510 charter members. From the outset, the group was conceived as a multidisciplinary organization. APS has enjoyed solid growth since its early days and today has approximately 3,200 members. The Board of Directors includes physicians, nurses, psychologists, basic scientists, pharmacists, policy analysts and more.
The new APS guideline, based on an extensive review of existing research, provides clinicians with eight recommendations to help determine the best way to treat patients with low-back pain. It also expands its current and previously published guideline for initial evaluation and management of this chronic condition.
“These recommendations are based on an even more complete body of evidence than was available just a few years ago. Consequently, we believe these recommendations will give physicians more confidence when treating patients with persistent back pain,” said Roger Chou, M.D., lead author, director of the APS Clinical Practice Guideline Program, and associate professor of medicine (general internal medicine), Oregon Evidence-based Practice Center, Oregon Health & Science University.
“Unfortunately, randomized trials for a number of commonly used interventional procedures are still too limited to generate evidence-based recommendations, and our review also highlights the need for more research,” Chou added.
Low-back pain is the fifth most common reason for doctor’s visits and accounts for more than $26 billion in direct health care costs nationwide each year. While a number of interventional diagnostic tests and therapies, and surgery are available, and their use is increasing, in some cases their usefulness remains uncertain.
“We have advocated strongly in many of our recommendations for physicians to use shared decision making because of the relatively close trade-offs between potential benefits relative to harms, as well as costs and burdens of these various treatment options,” Chou explained. Shared decision making involves a patient’s full participation in medical choices after receiving comprehensive information about the impact of all options on his or her particular life situation.
To develop the guideline, a multidisciplinary APS panel, augmented by experts on interventional therapies, reviewed 3,348 abstracts and analyzed 161 relevant clinical trials. The panel found that the evidence for the use of these interventions was mixed, sparse or not available. Based on the data the panel gathered, the APS now recommends:
1. Against the use of provocative discography (injection of fluid into the disc in order to determine if it is the source of back pain) for patients with chronic nonradicular low-back pain.
2. The consideration of intensive interdisciplinary rehabilitation with a cognitive/behavioral emphasis for patients with nonradicular low-back pain who do not respond to usual, non-interdisciplinary therapies.
3. Against facet joint corticosteroid injection, prolotherapy, and intradiscal corticosteroid injections for patients with persistent nonradicular low-back pain, and insufficient evidence to guide use of other interventional therapies.
4. A discussion of risks and benefits of surgery and the use of shared decision making with reference to rehabilitation as a similarly effective option for patients with nonradicular low-back pain, common degenerative spinal changes, and persistent and disabling symptoms.
5. Insufficient evidence to guide recommendations for vertebral disc replacement.
6. A discussion of the risks and benefits of epidural steroid injections and shared decision making, including specific review of evidence of lack of long-term benefit for patients with persistent radiculopathy due to herniated lumbar disc.
7. A discussion of the risks and benefits of surgery and use of shared decision making that references moderate benefits that decrease over time for patients with persistent and disabling radiculopathy due to herniated lumbar disc or persistent and disabling leg pain.
8. Discussion of risks and benefits of spinal cord stimulation and shared decision making, including reference to the high rate of complications following stimulator placement for patients with persistent and disabling radicular pain following surgery for herniated disc and no evidence of a persistently compressed nerve root.
Chou and his colleagues also reaffirm their previous recommendation that all low-back pain patients stay active and talk honestly with their physicians about self care and other interventions. “In general, noninvasive therapies supported by evidence showing benefits should be tried before considering interventional therapies or surgery,” said Chou.
Recommendations from the first APS Clinical Practice Guideline on Low-Back Pain are intended for primary care physicians and appeared in the Oct, 2, 2007, issue of the Annals of Internal Medicine. For diagnosis, the first APS low-back pain guideline advises clinicians to minimize routine use of X-rays or other diagnostic tests except for patients known or believed to have underlying neurological or spinal disorders
About the American Pain Society
Based in Glenview, Ill., the American Pain Society (APS) is a multidisciplinary community that brings together a diverse group of scientists, clinicians and other professionals to increase the knowledge of pain and transform public policy and clinical practice to reduce pain-related suffering.APS was founded in 1978 with 510 charter members. From the outset, the group was conceived as a multidisciplinary organization. APS has enjoyed solid growth since its early days and today has approximately 3,200 members. The Board of Directors includes physicians, nurses, psychologists, basic scientists, pharmacists, policy analysts and more.
Saturday, February 7, 2009
Scans for low-back pain do not improve outcomes
OHSU researchers find regular MRI, CT, radiography scans unnecessary unless a significant underlying condition is first identified
Physicians should not immediately order routine scans for low-back pain unless they observe features of a serious underlying condition, researchers in the Oregon Evidence-Based Practice Center at Oregon Health & Science University report. Their findings are published in this week's edition of the The Lancet.
The regular use of radiography, MRI or CT scans in patients with low-back pain but no indication of a significant underlying condition does not improve their outcome, the researchers report.
"Our study shows that performing routine X-rays or MRIs for patients with low-back pain does not lead to improved pain, function or anxiety level, and there were even some trends toward worse outcomes," said Roger Chou, M.D., lead author; scientific director of the Oregon Evidence-Based Practice Center at OHSU; and associate professor of medical informatics and clinical epidemiology, and medicine (general internal medicine and geriatrics) in the OHSU School of Medicine.
"Clinicians may think they are helping patients by doing routine X-rays or MRIs, but these diagnostic tests increase medical costs, can result in unnecessary surgeries or other invasive procedures, and may cause patients to stop being active — probably the best thing for back health — because they are worried about common findings such as degenerated discs or arthritis, not understanding that these are very weakly associated with back pain."
To reach this conclusion, Chou and colleagues conducted a meta-analysis of randomized controlled trials that compared immediate back imaging — using one of the three scanning types above — with usual clinical care that does not involve immediate imaging. Six trials covering more than 1,800 patients were included, reporting a range of outcomes including pain and function, quality of life, mental health, overall patient-reported improvement, and patient satisfaction.
The analysis found no significant differences between immediate imaging and usual clinical care. The authors say that the results are most applicable to acute or sub-acute low-back pain of the type assessed in a primary care setting with the patient's family doctor.
The authors report that lumbar imaging for low-back pain without indications of serious underlying conditions does not improve clinical outcomes. Therefore, clinicians should refrain from routine, immediate lumbar imaging in patients with acute or subacute low-back pain and without features suggesting a serious underlying condition.
They added: "Rates of utilization of lumbar MRI are increasing, and implementation of diagnostic-imaging guidelines for low-back pain remains a challenge. However, clinicians are more likely to adhere to guideline recommendations about lumbar imaging now that these are supported by consistent evidence from higher-quality randomized controlled trials."
Patient expectations and preferences about imaging should also be addressed, because 80 percent of patients with low-back pain in one trial would undergo radiography if given the choice, despite no benefits with routine imaging, the reporters report. They indicated educational interventions for reducing the proportion of patients with low-back pain who believe that routine imaging should be done.
Other investigators who participated in this study include: Rick Deyo, M.D., M.P.H., Kaiser Permanente Professor of Evidence-Based Family Medicine, OHSU School of Medicine, Oregon Evidence-Based Practice Center; and Rochelle Fu, Ph.D., assistant professor of public health and preventive medicine, OHSU School of Medicine.
In an accompanying comment, Michael M. Kochen, Department of General Practice, University of Göttingen, Germany, and colleagues discuss how certain factors could hamper doctors changing practice to avoid immediate imaging, "such as patients' expectations about diagnostic testing, reimbursement structures providing financial incentives, or the fear of missing relevant pathology." They conclude: "Meanwhile a promising approach seems to be the way of educating patients in and outside general practitioners surgeries."
Physicians should not immediately order routine scans for low-back pain unless they observe features of a serious underlying condition, researchers in the Oregon Evidence-Based Practice Center at Oregon Health & Science University report. Their findings are published in this week's edition of the The Lancet.
The regular use of radiography, MRI or CT scans in patients with low-back pain but no indication of a significant underlying condition does not improve their outcome, the researchers report.
"Our study shows that performing routine X-rays or MRIs for patients with low-back pain does not lead to improved pain, function or anxiety level, and there were even some trends toward worse outcomes," said Roger Chou, M.D., lead author; scientific director of the Oregon Evidence-Based Practice Center at OHSU; and associate professor of medical informatics and clinical epidemiology, and medicine (general internal medicine and geriatrics) in the OHSU School of Medicine.
"Clinicians may think they are helping patients by doing routine X-rays or MRIs, but these diagnostic tests increase medical costs, can result in unnecessary surgeries or other invasive procedures, and may cause patients to stop being active — probably the best thing for back health — because they are worried about common findings such as degenerated discs or arthritis, not understanding that these are very weakly associated with back pain."
To reach this conclusion, Chou and colleagues conducted a meta-analysis of randomized controlled trials that compared immediate back imaging — using one of the three scanning types above — with usual clinical care that does not involve immediate imaging. Six trials covering more than 1,800 patients were included, reporting a range of outcomes including pain and function, quality of life, mental health, overall patient-reported improvement, and patient satisfaction.
The analysis found no significant differences between immediate imaging and usual clinical care. The authors say that the results are most applicable to acute or sub-acute low-back pain of the type assessed in a primary care setting with the patient's family doctor.
The authors report that lumbar imaging for low-back pain without indications of serious underlying conditions does not improve clinical outcomes. Therefore, clinicians should refrain from routine, immediate lumbar imaging in patients with acute or subacute low-back pain and without features suggesting a serious underlying condition.
They added: "Rates of utilization of lumbar MRI are increasing, and implementation of diagnostic-imaging guidelines for low-back pain remains a challenge. However, clinicians are more likely to adhere to guideline recommendations about lumbar imaging now that these are supported by consistent evidence from higher-quality randomized controlled trials."
Patient expectations and preferences about imaging should also be addressed, because 80 percent of patients with low-back pain in one trial would undergo radiography if given the choice, despite no benefits with routine imaging, the reporters report. They indicated educational interventions for reducing the proportion of patients with low-back pain who believe that routine imaging should be done.
Other investigators who participated in this study include: Rick Deyo, M.D., M.P.H., Kaiser Permanente Professor of Evidence-Based Family Medicine, OHSU School of Medicine, Oregon Evidence-Based Practice Center; and Rochelle Fu, Ph.D., assistant professor of public health and preventive medicine, OHSU School of Medicine.
In an accompanying comment, Michael M. Kochen, Department of General Practice, University of Göttingen, Germany, and colleagues discuss how certain factors could hamper doctors changing practice to avoid immediate imaging, "such as patients' expectations about diagnostic testing, reimbursement structures providing financial incentives, or the fear of missing relevant pathology." They conclude: "Meanwhile a promising approach seems to be the way of educating patients in and outside general practitioners surgeries."
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