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HealthDay

By Diana Kohnle

Wednesday, June 30, 2010

(HealthDay News) -- If you still have pain more than six months after an injury or illness, it's said to be chronic.

The American Academy of Family Physicians suggests how people with chronic pain can manage:

With medication, which may include pain relievers, antidepressants or anticonvulsants.

With physical therapy.

With low-impact exercise. Examples may include walking and swimming.

With occupational therapy, which teaches how to do things in ways that don't aggravate pain.

With behavioral therapy, which teaches managing stress and relaxing as ways to help reduce pain.

By getting lots of sleep.

By quitting smoking.

HealthDay

Copyright (c) 2010 HealthDay. All rights reserved.

http://tinyurl.com/297lmn8

Post edited by: Bettyg, at: 08/30/2010 01:16 AM

By Nancy Walsh, Staff Writer, MedPage Today

Published: July 07, 2010

Reviewed by

Zalman S. Agus, MD; Emeritus Professor

University of Pennsylvania School of Medicine and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Action Points

■Explain to interested patients that their understanding and beliefs about low back pain and its causes and treatments can be an important factor in their level of disability.

■Further explain that the findings of this study, conducted in a single metropolitan suburban area in Western Australia, may not be generalizable to other populations.

Among patients with low back pain, negative beliefs and behaviors -- such as believing their problem will not get better -- are important correlates of increased disability, according to an Australian cohort study.

In data culled from questionnaires, patients with high levels of disability associated with low back pain expressed significantly more negative beliefs about physical activity, time off work, and the need for bed rest compared with those reporting low levels of disability (P<0.05), according to Andrew M. Briggs, PhD, of Curtin University of Technology in Perth, and colleagues.

In contrast, pain intensity and functional health literacy skills did not correlate with patients' disability levels, the researchers reported online in the journal Pain.

Poor health literacy -- an individual's ability to seek, understand, and utilize health information -- has been linked with limited self-management skills in other chronic conditions such as asthma and rheumatoid arthritis, but the influence of health literacy has not previously been investigated in low back pain.

In addition, differences in these skills between low back pain patients who report high and low levels of disability have not yet been explored, which could have implications for prevention and treatment strategies.

So Briggs and colleagues analyzed data from a community-based cohort in a middle class metropolitan suburb north of Perth in Western Australia, collecting demographic and clinical data with a series of questionnaires for 56 subjects with low back pain and 61 without.

These questionnaires enumerated pain severity and impact, disability, fear avoidance, beliefs about low back pain, pain catastrophizing, and health literacy.

In-depth telephone interviews also were conducted with 36 participants in the back pain group to assess their beliefs about the cause and course of low back pain and to more fully and qualitatively explore their health literacy skills.

Scores on the short form Test of Functional Health Literacy in Adults were found to be adequate in all study participants, with no differences in scores between patients with and without back pain or according to level of disability.

Literacy scores also were not associated with back pain beliefs, fear avoidance beliefs, or pain catastrophizing.

To analyze potential differences according to level of disability, patients were subdivided according to the Oswestry Disability Index. Those with greater disability reported the following:

•Higher levels of fear avoidance beliefs about physical activity (r2=0.30, P<0.001)

•More negative back pain beliefs (r2=0.17, P=0.002)

•More pain catastrophizing (r2=0.15, P=0.003

Patients with high levels of disability were less optimistic that their condition would improve because of their age, lack of mobility, and overall "wear and tear," while those with low disability believed that their symptoms would improve with health education and treatment.

Patients in both groups named health professionals as their primary source for information about low back pain and favored physiotherapists and chiropractors over primary care physicians for specialized information.

This preference may reflect differences in style, duration, and content of the patient-caregiver interaction, according to the authors.

Patients also relied on family and friends for information, and those with high disability further sought information on the Internet and from medical literature. All agreed that mass media campaigns about low back pain would be helpful.

Participants "overwhelmingly" stated that understanding their condition, its causes, and its management was hampered by the overuse of complex medical terminology, and requested more use of visual diagrams and skeletal models for explanations.

They also admitted that they often did not follow prescribed treatment regimens, but said that if they were given clearer information and more fully understood the condition and its treatments they would be more likely to be adherent.

Other contributors to lack of treatment utilization included costs and lack of time.

The fact that the researchers were unable to differentiate between patients with and without low back pain by health literacy scores may demonstrate the inadequacy of the tool, which measures only numeracy and reading comprehension.

A more comprehensive instrument that also assessed communication skills and attitudes would be helpful, they said.

One strength of the study was its mixed method design, which allowed in-depth evaluation of health literacy in chronic low back pain patients, according to the authors.

Study limitations included its narrow geographical recruitment and homogeneous sample from a single middle class metropolitan suburb, as well as a lack of qualitative data from participants without back pain.

"Future studies should explore health literacy in the context of back pain in a cohort with more heterogeneity in health literacy levels and socioeconomic status and explore tools which capture the broader elements of health literacy," the authors concluded.

Funding for the study was provided by Curtin University of Technology and Edith Cowan University.

Several of the researchers are supported by fellowships awarded by the Australian National Health and Medical Research Council.

All authors declared no conflicts of interest.

Primary source: Pain

Source reference:

Briggs A, et al "Health literacy and beliefs among a community cohort with and without chronic low back pain" Pain 2010; DOI: 10.1016/j.pain.2010.04.031.

http://tinyurl.com/2ayk4my

Post edited by: Bettyg, at: 08/30/2010 01:15 AM

Study finds it's no better than placebo in relieving discomfort or boosting quality of life

URL of this page: http://www.nlm.nih.gov/medlineplus/news/ fullstory_100753.html (*this news item will not be available after 10/04/2010)

Tuesday, July 6, 2010

Related MedlinePlus Pages

Back Pain

Complementary and Alternative Medicine

Osteoarthritis

TUESDAY, July 6 (HealthDay News) --

The popular supplement glucosamine offers little or no relief for sufferers of chronic lower back pain caused by osteoarthritis, a new study finds.

The Norwegian trial seems to be another knock against glucosamine, with other recent studies showing similar results.

"The study answer the questions:

'I have suffered low back pain for a long time (more than 6 months), will a 6-month intake of glucosamine help me?'" said lead researcher Philip Wilkens, a research fellow in the orthopedic department at the University of Oslo.

"And the answer according to this study is no."

On the up side, "glucosamine appears safe to use," he added. "And more research is needed to answer if glucosamine is beneficial to prevent chronic low back pain or have benefits in longer term, like 5 to 10 years."

Osteoarthritis affects more than 20 million Americans, and the number is expected to increase, the researchers note.

Glucosamine is a common over-the-counter treatment for osteoarthritis, even though its use has been controversial.

For example, a University of Pittsburgh study presented at a rheumatologists' meeting in October found the supplement did not prevent loss of cartilage in osteoarthritic knees, while studies published in 2008 in Arthritis & Rheumatism and the Annals of Internal Medicine found glucosamine had little or no effect on arthritis of the knee and hips, respectively.

The new report is published in the July 7 issue of the Journal of the American Medical Association.

For the study, Wilkens's team randomly assigned 250 patients with chronic back pain and degenerative lumbar osteoarthritis to 1,500 milligrams daily of glucosamine or an inactive placebo.

The patients' pain was measured using the Roland Morris Disability Questionnaire at 6 weeks, then again at 3, 6 and 12 months.

In addition, the researchers evaluated the patients' self-reported quality of life.

At the start of the 6-month trial, patients taking glucosamine scored 9.2 on the pain scale while the patients taking placebo scored 9.7, the researchers note.

At the 6-month point, both groups scored 5.0, and after one year the glucosamine group scored 4.8 while the placebo group scored 5.5, Wilkens's group found.

However, the small differences in scores at six months or one year were not statistically significant, the researchers say.

Nor were minor differences in quality of life between the two groups deemed significant.

The bottom line, according to Wilkens: "People with chronic low back pain and degenerative osteoarthritis will not benefit more from glucosamine than placebo for treating their back problem."

Dr. Andrew L. Avins, a scientist in the division of research at Kaiser Permanente Northern California and the author of an accompanying journal editorial, said that, "from a clinical standpoint, the study demonstrates that glucosamine does not appear to be better than placebo for patients with chronic low back pain and spinal arthritis."

However, the study found no ill effects from taking the supplement.

So, patients who take glucosamine and feel that it is helping them should be reassured that it's at least not harmful, said Avins, who is also professor of medicine, epidemiology & biostatistics at the University of California, San Francisco.

"The larger implications [of this study] are that we still know very little about how to help most patients with chronic low back pain, and we need much more careful, directed research to help make progress in providing relief to patients with back pain," he added.

Even though back pain is an incredibly important public health and quality of life problem, it suffers from insufficient attention and research funding, Avins believes.

"In the U.S., we spend far more on treatments of little or questionable value than we spend on research to find effective therapies; it's a poor use of scarce health-care resources," he said.

Dr. Andrew Sherman, an associate professor and vice-chair of the department of rehabilitation medicine at the University of Miami Leonard M. Miller School of Medicine, agreed that the findings should dissuade doctors from recommending glucosamine to patients with back pain.

However, "this [study] is not going to stop people from trying it," he added, and the finding does not mean that glucosamine won't work for other forms of arthritis.

SOURCES:

Philip Wilkens, M.Chiro., research fellow, orthopedic department, University of Oslo, Norway;

Andrew L. Avins, M.D., M.P.H., research scientist, Division of Research, Kaiser Permanente Northern California, professor, of medicine, epidemiology & biostatistics, University of California, San Francisco;

Andrew Sherman, M.D., associate professor and vice-chair, department of rehabilitation medicine, University of Miami Leonard M. Miller School of Medicine,

July 7, 2010, Journal of the American Medical Association

HealthDay

Copyright (c) 2010 HealthDay. All rights reserved.

http://www.nlm.nih.gov/medlineplus/news/ fullstory_100753.html

Post edited by: Bettyg, at: 07/15/2010 08:13 PM

By Nancy Walsh, Staff Writer, MedPage Today

Published: July 26, 2010

Reviewed by Adam J. Carinci, MD; Instructor, Harvard Medical School and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner Earn CME/CE credit

for reading medical news

Action Points

------------------------------------------------------------ --------------------

■Explain to interested patients that eliminating diagnostic nerve blocks before lumbar facet radiofrequency denervation increased the success of the procedure.

■Also explain that the trial found that avoiding diagnostic nerve blocks also reduced costs.

While some guidelines recommend two diagnostic nerve blocks before radiofrequency treatment for chronic low back pain, a randomized trial showed greater success without use of the prior blocks.

The randomized, multicenter study conducted among 151 patients with chronic low back pain, also showed that eliminating the diagnostic nerve blocks substantially reduced costs, according to Steven P. Cohen, MD, of Johns Hopkins in Baltimore and colleagues.

Writing in the August issue of Anesthesiology, Cohen and colleagues determined the comparative costs (P<0.001) of successful radiofrequency denervation with and without preceding facet joint nerve blocks to be:

•No prior screening block, $6,286

•A single diagnostic block, $17,142

•Two confirmatory blocks, $15,241

Numerous organizations and guidelines have advocated the double-block paradigm for the confirmatory diagnosis of lumbar facet arthropathy, but diagnostic spinal injections can be inaccurate and associated with false-negative responses, the researchers wrote.

And although official guidelines have advocated the double-block standard, several randomized trials suggested that single blocks might suffice.

Furthermore, diagnostic blocks are not without serious complications, such as neuraxial infection, while increasing concerns about cost-effectiveness have added to a growing controversy about the need for confirmatory blocks.

To explore both efficacy and cost-effectiveness, Cohen and colleagues randomized 151 patients with chronic low back pain, with the endpoints of cost and "successful outcome" -- which consisted of a 50% or more reduction in pain and a positive global perceived effect that persisted for three months or more.

Most patients were in their 40s, and men predominated.

Median duration of symptoms was three to four years.

The first diagnostic block was positive in 40% of patients in the single-block group and in 58% of those in the double-block group.

Among responders to the first block, pain relief was substantial, at 77.5% and 75% in the single- and double-block groups, respectively.

In the double-block group, 48% had a positive second block.

Denervation success rates were 33% in the no-block group, 39% in the single-block group, and 64% in the double-block group.

The proportion of successful outcomes was highest in the group that had no screening blocks, with 58.8% at one month and 33.3% at three months.

In contrast, successful outcomes at those time points were seen for 26% and 16% in the single-block group and 22.5% and 22% of those in the double-block group (P<0.001).

"Our results suggest that the current controversy surrounding whether single or double blocks are superior may be misguided.

Instead, the operative question may be whether any blocks should be done before lumbar z-joint denervation," the researchers wrote.

However, they cautioned against the abandonment of diagnostic blocks altogether, because many of the responders in the no-block group were likely to have been placebo responders.

Moreover, the investigators noted, "The current reimbursement paradigm for facet interventions is an artificial construct incommensurable with that for other spinal interventions (e.g., spinal fusions, decompression surgeries), wherein the diagnostic procedure generally is reimbursed only a small fraction of the 'definitive' treatment."

They also noted that the study had its flaws, including a lack of blinding and placebo control, as well as the three-month cutoff for response.

Their findings also might be affected by changes in reimbursement. "The conclusions drawn today might differ from those drawn tomorrow, contingent on decisions from third-party payers."

In an accompanying editorial in the same issue of Anesthesiology, Jan Van Zundert, MD, PhD, of Maastricht University in the Netherlands, and colleagues, wrote,

"The design and findings of this study provide an important contribution to the ongoing debate on patient selection and the so-called diagnostic blocks."

But an important and, as-yet unaddressed, problem is the lack of a definitive standard on how diagnostic blocks should be performed -- with wide variations being seen in patient selection, technique, medications used, and doses, Van Zundert and colleagues pointed out.

"Standardization and scientific validation of (controlled) diagnostic medical branch blocks is highly needed to identify its real value in clinical practice," the editorialists wrote.

The study was supported in part by a grant from the John P. Murtha Neuroscience and Pain Institute, the U.S. Army, and the Army Regional Anesthesia and Pain Medicine Initiative.

The editorialists declared that they had no financial disclosures.

Primary source: Anesthesiology

Source reference:

Cohen S, et al "Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation" Anesthesiology 2010; 113:1-1111.

Additional source: Anesthesiology

Source reference:

Van Zundert J, et al "Diagnostic medial branch blocks before lumbar radiofrequency zygapophysial (facet) joint denervation: benefit or burden?" Anesthesiology 2010; 113: 1-3.

http://tinyurl.com/26m6rul

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Brain scans show more neural activity between certain brain networks and pain processing region

URL of this page: http://www.nlm.nih.gov/medlineplus/news/ fullstory_101889.html (*this news item will not be available after 11/03/2010)

Thursday, August 5, 2010

THURSDAY, Aug. 5 (HealthDay News) --

Fibromyalgia patients have more "connectivity" between brain networks and regions of the brain involved in pain processing, which may help explain why sufferers feel pain even when there is no obvious cause, a new study suggests.

Researchers had 18 women with fibromyalgia undergo six-minute fMRI brain scans, and compared their results to women without the condition.

Participants were asked to rate the intensity of the pain they were feeling at the time of the test. Some people reported feeling little pain, while others reported feeling more intense pain.

Brain scans showed the connectivity, or neural activity, between certain brain networks and the insular cortex, a region of the brain involved in pain processing, was heightened in women with fibromyalgia compared to those without the condition.

The connectivity to the insular cortex was even stronger in participants who reported feeling more intense pain compared to milder pain, said study author Vitaly Napadow, a neuroscientist at Massachusetts General Hospital.

"We took advantage of the fact that there is a large discrepancy in the amount of pain patients happen to be in at the time they come in. Unfortunately some patients come in, and they are in a lot of pain. Other patients come in and they are not in pain," Napadow said.

The study, by researchers from Massachusetts General Hospital and the University of Michigan, is published in the August issue of Arthritis & Rheumatism.

Fibromyalgia is a chronic pain syndrome that's characterized by widespread pain, fatigue, insomnia, and the presence of multiple tender points.

The syndrome can also cause psychological issues, including anxiety, depression and memory and concentration problems, sometimes called the "fibromyalgia fog."

Prior research has shown that people with fibromyalgia feel a given amount of pain more intensely than others, Napadow explained. In other words, studies have shown a typical person might rate a painful stimuli a "one" on a scale or one to 10, while a person with fibromyalgia might rate the pain a 5 or higher.

The new study is different in that fibromyalgia patients' pain responses were measured while they were at rest and not being exposed to anything painful, Napadow said.

The brain networks involved were the default mode network (DMN) and the right executive attention network (EAN).

The DMN is involved in "self-referential thinking," when you think about yourself or what's happening to you, Napadow explained.

The EAN is involved in working memory and attention.

When that brain network is occupied, or distracted, by pain, it may explain some of the cognitive issues that fibromyalgia patients experience, Napadow said.

Dr. Philip Mease, director of rheumatology research at Swedish Medical Center in Seattle and a member of the National Fibromyalgia Association medical advisory board, said the study provides insight into what may be going on in the brains of people with fibromyalgia.

"This work shows there is increased connectivity between different brain centers that connect the purely sensory pain processing centers of the brain with some of the emotional and evaluative parts of the brain, or areas of the brain that take a sensory stimulus and say,

"How do I interpret this? How do I feel about this'?" Mease said.

For years, fibromyalgia has been a highly misunderstood syndrome, with some doctors doubting it even existed, and others attributing the pain to depression or other psychological issues.

That began to change early this decade, when brain scans showed pain-processing abnormalities in fibromyalgia patients, Mease said.

"That first neuroimaging study really demonstrated fibromyalgia patients were different than normal individuals, and at a neurobiological level, were truly experiencing more pain at lower intensities," Mease said.

The new research moves understanding of the condition a step further, by exploring what's happening in the brain during a resting state.

"Regardless of poking or prodding them, this study is trying to get at an understanding of what is crackling in the brain, intrinsically, such that they have this higher sensitivity," Mease said.

About 10 million Americans are believed to have fibromyalgia, almost 90 percent of whom are women, according to the National Fibromyalgia Association.

Sufferers report a history of widespread pain in all four quadrants of the body for at least three months, and pain in at least 11 of 18 "tender points."

SOURCES:

Vitaly Napadow, Ph.D, neuroscientist and assistant professor, radiology, Massachusetts General Hospital, Harvard Medical School, Boston;

Philip Mease, M.D., director, rheumatology research, Swedish Medical Center, Seattle, and member,

National Fibromyalgia Association medical advisory board;

August 2010 Arthritis & Rheumatism

HealthDay

Copyright (c) 2010 HealthDay. All rights reserved.

http://www.nlm.nih.gov/medlineplus/news/ fullstory_101889.html

Four factors keep students from shouldering a too-heavy load

URL of this page: http://www.nlm.nih.gov/medlineplus/news/ fullstory_101968.html (*this news item will not be available after 11/05/2010)

By Robert Preidt

Saturday, August 7, 2010

SATURDAY, Aug. 7 (HealthDay News) --

As the new school year approaches, parents and children planning their "back-to-school" lists are urged to keep backpack safety in mind.

Each year, about 6,000 children in the United States experience backpack-related injuries, Linda Rhodes, an occupational therapist at MCGHealth Children's Medical Center in Augusta, Ga., explained in a news release from the medical center.

In an effort to cut down on the number of these injuries, Rhodes offers parents the following backpack safety advice:

•Choose a lightweight backpack that doesn't add too much to your child's load.

The pack should have two wide, padded shoulder straps and a padded back that will improve comfort and protect your child from being poked by the sharp points and edges of pencils, pens, rulers and other objects they need to carry.

•Select the proper size backpack for your child. It should cover no more than three-quarters of the length of your child's back.

•Load backpacks carefully. The maximum weight of a loaded pack should not be more than 15 percent of a child's body weight.

Place the heaviest books closest to the back as they require the most body support.

If a child has to lean forward to carry a pack, it's too heavy.

•Have your child wear the pack correctly. He or she should use both shoulder straps.

Carrying a backpack on one shoulder puts too much strain on one side of the upper body.

The straps should be snug, but not too tight. If a backpack has a waist strap, use it to help better support the load.

SOURCE: MCGHealth Children's Medical Center, news release, Aug. 2, 2010

HealthDay

http://www.nlm.nih.gov/medlineplus/news/ fullstory_101968.html

Copyright (c) 2010 HealthDay. All rights reserved.

By Crystal Phend, Senior Staff Writer, MedPage Today

Published: April 16, 2010

Reviewed by

Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Chronic pain may reverse the neural response to acute pain in some ways, researchers found.

The central nervous system sensory activation patterns and subjective sensation of pain were largely identical between healthy volunteers and chronic back pain sufferers in a brain imaging study reported in the April 15 issue of Neuron.

The difference was in how the nucleus accumbens region of the brain interpreted acute pain as a motivation for behavior, according to A. Vania Apkarian, PhD, of Northwestern University in Chicago, and colleagues.

Action Points

■Explain to interested patients that a number of changes have been seen in the brain of individuals with chronic pain, including abnormal brain chemistry, regional gray matter atrophy, cognitive changes, and unique patterns of brain activity.

At the end of a painful heat stimulus, this portion of the brain registered phasic activity in chronic pain patients with the opposite polarity of that seen in healthy adults.

Although removal of a painful sensation usually registers as a reward, among chronic pain patients it actually appeared to reflect a predicted punishment, the researchers explained.

Acute pain robustly reduced the level of chronic pain perceived (P<0.004), such that its end predicted worsening of ongoing back pain, they suggested.

Apkarian's group called this a potential "dysfunctional associative learning process" involved in the transition from acute back pain to chronic back pain.

The switch in the brain's prediction and valuation of the pain -- mediated by the nucleus accumbens and related circuitry -- likely plays a role, not in the actual sensory perception, but in the internal state as "an integral component of the pathophysiology of chronic pain," they wrote in Neuron.

Other changes have been shown in chronic pain in prior studies, including abnormal brain chemistry, regional gray matter atrophy, cognitive changes, and unique patterns of brain activity.

However, the phasic activity in the nucleus accumbens at the end of the painful stimulus was unique, they said.

For the study, the researchers imaged the brain using functional MRI while administering a pseudo-random series of nine thermal stimuli ranging from 47° to 51°C of 12 to 30 seconds each in 16 healthy adults and 16 patients with physician-diagnosed chronic back pain.

An additional eight chronic back pain patients rated chronic pain and pain associated with the stimuli but without MRI imaging.

During the fMRI tests, brain activity during the period when the heat was being applied and the pain reported from it was similar between groups.

But healthy individuals showed higher nucleus accumbens activity in the period when the thermal heat was decreasing and the pain was coming to an end compared with chronic pain patients (P<0.0001).

This difference at offset of pain distinguished the two groups with 100% sensitivity and 100% specificity, "implying that this signal can be used as an objective marker of chronic pain," Apkarian's group wrote.

Nucleus accumbens activity during this stimuli offset period appeared to be influenced from differing cortical sources between the two groups, too.

Activity in the insula best represented the magnitude of pain perception in this period among healthy controls.

Meanwhile, the nucleus accumbens in chronic back pain patients was more strongly connected with activity in the medial prefrontal cortex -- a brain area implicated in valuation, action selection, and pain modulation.

Chronic pain patients also had a higher poststimulus baseline activity (both P<0.0001), a difference that had 60% sensitivity and 66.7% specificity in distinguishing them from healthy volunteers.

The study was funded by a grant from the National Institute of Neurological Disorders and Stroke.

The researchers provided no information on conflicts of interest.

Primary source: Neuron

Source reference:

Baliki MN, et al "Predicting value of pain and analgesia: Nucleus accumbens response to noxious stimuli changes in the presence of chronic pain" Neuron 2010; 66: 149–60.

© 2004-2010 MedPage Today, LLC. All Rights Reserved.

http://tinyurl.com/26doat6

By Charles Bankhead, Staff Writer, MedPage Today

Published: February 04, 2010

Reviewed by

Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Action Points

■Explain to patients that a biological therapy that inhibits nerve growth factor reduced pain in patients with three types of pain syndromes.

■Note that the agent is investigational and not yet available.

■Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

SAN ANTONIO -- A humanized monoclonal antibody against nerve growth factor provided relief in three chronic pain syndromes, according to a summary of small studies reported as an abstract here.

Treatment with tanezumab led to statistically or clinically significant reductions in pain for patients with osteoarthritis, chronic lower back pain, and interstitial cystitis.

The most common adverse events were transient abnormal peripheral sensations, which generally occurred only after the first infusion.

"Patients with these three different pain syndromes all had significant improvement when treated with tanezumab," Leslie Tive, PhD, of Pfizer, said in an interview at the American Academy of Pain Medicine meeting.

"The pain relief was sustained over time, and patient acceptance was good."

"Nerve growth factor is increased in many types of chronic pain and therefore represents an attractive target for therapy," she added.

"Tanezumab is being evaluated in some of these other conditions in ongoing studies."

A small phase I study showed that the humanized monoclonal antibody resulted in significant pain improvement in patients with osteoarthritis (Arthritis Rheum 2005; 52: S461).

Five presented data from a phase II trial involving 400 patients with osteoarthritis of the knee.

They were randomized to placebo or to one of five tanezumab doses, administered on day one and day 56.

All five doses of tanezumab resulted in significant reductions (P<0.05) versus placebo after one week and were sustained through 16 weeks.

As assessed by a visual analog scale, the mean change in pain on walking from baseline to week 16 ranged from 30 to 45 points (P<0.0001), a two- to threefold difference compared with placebo.

The trial in chronic low back pain involved 217 adults with Quebec Task Force on Spinal Disorders category 1 or 2 pain for at least three months.

The primary location of the pain was between the 12th thoracic vertebra and the lower gluteal folds.

Eligibility criteria included a score of at least 4 on an 11-point pain scale on at least four occasions in the five days before randomization, as indicated by entries in an electronic pain diary.

Patients were randomized 2:2:1 to a single infusion of tanezumab, to oral naproxen, or to placebo.

The primary endpoint was the change in mean Lower Back Pain Index score from baseline to six weeks, averaged over the last seven days.

Beginning at week one and continuing through week six, patients who were randomized to either dose of tanezumab had significantly greater improvement in pain than those who took the placebo (P<0.05 to P<0.001), and compared with the naproxen group beginning at week two (P<0.05 to P<0.01).

The interstitial cystitis study included 64 men and women who had a score ≥13 on Pelvic Pain Symptom/Frequency questionnaire, ≥7 score on the O'Leary-Sant Interstitial Cystitis index, and micturition frequency ≥8 times a day, as recorded in an electronic diary for at least five consecutive days prior to randomization.

Patients were randomized to intravenous tanezumab or matching placebo. The primary efficacy endpoint was change from baseline to six weeks in the 11-point pain scale.

A difference of at least one point from placebo was considered clinically significant. Statistical significance was not evaluated.

The mean difference between tanezumab and placebo was -0.7 at week two, increasing to -1.1 at week four and -1.4 at week six. The advantage versus placebo was maintained at week 10 (-0.9) and week 16 (-0.5).

Adverse events were evaluated for all patients combined in the three studies. Adverse events were reported by 66.3% of tanezumab patients, 61.4% of naproxen patients, and 59.3% of placebo patients.

Serious and severe adverse events occurred in 1.6% to 3.4% of patients and 4.8% to 5.7%, respectively.

Tive said 14.4% of tanezumab patients reported abnormal peripheral sensations, the most common being paresthesia (7.1%), hyperesthesia (4.1%), and hypoesthesia (3.9%).

The studies included in the summary were funded by Pfizer.

Investigators included several Pfizer employees.

Primary source: American Academy of Pain Medicine

Source reference:

Tive L, et al "Tanezumab, a humanized anti-nerve growth faactor antibody, in the treatment of three chronic pain types" AAPM 2010; Abstract 151.

© 2004-2010 MedPage Today, LLC. All Rights Reserved.

http://tinyurl.com/2ax4xes

But most patients gained pain relief without the need for vertebroplasty, experts note

URL of this page:

http://www.nlm.nih.gov/medlineplus/news/ fullstory_102019.html (*this news item will not be available after 11/08/2010)

Tuesday, August 10, 2010

TUESDAY, Aug. 10 (HealthDay News) --

After studies last year found that a type of surgery called vertebroplasty was no better than a sham procedure in treating painful compression fractures, a new study now suggests the therapy can, in fact, ease some patients' pain.

In this (typically) outpatient procedure, doctors inject a type of stabilizing cement into the affected part of the spine.

For some people with weak bones who fracture the small bones in their spine -- an injury called an acute osteoporotic vertebral compression fracture -- vertebroplasty can be a safe and effective treatment, Dutch researchers conclude in the Aug. 10 online edition of The Lancet.

The study was funded in part by Cook Medical, which makes material used in vertebroplasty.

"Pain relief after the procedure is immediate, sustained for one year, and is significantly better than that achieved with conservative treatment and at acceptable costs," wrote a team led by Dr. Caroline Klazen, from St. Elisabeth Ziekenhuis in Tilburg, the Netherlands.

But other experts cast doubt on the findings, noting that for most of the study participants, pain resolved on its own without the need for surgery.

The new Dutch study involved 431 patients, aged 50 or older, with osteoporotic vertebral compression fractures. The patients had been in pain for six weeks or less.

The researchers randomly assigned them to receive vertebroplasty or conservative treatment.

Conservative treatment included taking pain relievers, ice and heat treatments, and later a stretching and back strengthen program.

In addition, a back brace may be called for, experts say.[/b

]

However, the researchers noted that more than half (53 percent) of participants had their pain spontaneously disappear during the assessment phase of the study.

Among the 202 remaining patients, the 101 treated with vertebroplasty had greater pain relief after a month and a year, compared with those who underwent conservative treatment, Klazen's group found.

But even among those who did not get vertebroplasty, 60 percent achieved pain relief, leaving only 41 whose pain continued without therapy.

There were no serious side effects or complications from vertebroplasty, the researchers stated.

One important drawback to the study was that patients and doctors knew who received which therapy, Klazen's team noted. That could have affected patient responses and the radiologists' assessments, they noted.

Not everyone was convinced by the study findings.

[b]The fact that many people saw their pain clear up on their own, without the surgical intervention, "confirms that we have been managing patients appropriately for all these years -- by waiting six weeks [before treatment]," said Dr. David F. Kallmes a professor of radiology at the Mayo Clinic. He was not involved in the study.

Kallmes helped conduct one of the studies published in 2009 in the New England Journal of Medicine that found the surgery was no better than a "sham" procedure in treating compression fracture pain.

Kallmes noted that of the 431 patients selected for the study, more than 50 percent improved without treatment.

"And among the 100 who didn't get treated [with vertebroplasty], 60 percent of those achieved relief at one month.

That means that almost 90 percent of the 330 patients who didn't receive cement achieved a good outcome without cement," he said.

If those patients who would not improve without treatment could be identified, that "would be great," Kallmes said.

"But we still are unable to" spot those patients, he added, so it's difficult to predict which patients would gain from the surgical technique.

Compared to standard therapy, cost could become a factor, as well.

Although the researchers call vertebroplasty's price tag "acceptable," total costs can run about $5,000 including the cost of an MRI scan, Kallmes said.

Another expert, Dr. Eugene J. Carragee, a professor of orthopedic surgery and chief of the spine surgery center at Stanford University, is also not a fan of vertebroplasty for most patients.

"None of the controlled trials, including this one, have even remotely confirmed the 80 to 90 percent rate of complete and immediate pain relief described in original reports of this procedure," he noted.

In fact, about 60 to 70 percent of the effect seen in the vertebroplasty group was also seen in the control group, Carragee said. "This strongly suggests that most of the improvement in the vertebroplasty group was not due to the procedure alone," he pointed out.

"The vertebroplasty treatment effect probably includes some direct effect and some placebo effect. But it is unlikely that all of the apparent treatment effect is placebo," Carragee added.

SOURCES:

David F. Kallmes M.D., professor, radiology, Mayo Clinic, Rochester, Minn.;

Eugene J. Carragee, M.D., professor, orthopedic surgery, and chief, spine surgery center, Stanford University, Stanford, Calif.;

Aug. 10, 2010, The Lancet, online

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