100-Year-Old Woman Gets Relief From Debilitating Back Pain After Minimally Invasive Spine Surgery

25 oct 2009--On World Osteoporosis Day, October 20, centenarian Helen Daniels of Poughkeepsie, NY, has a good reason to smile; she's able to comfortably walk again following minimally invasive spine surgery. After suffering two spinal fractures caused by osteoporosis, Mrs. Daniels had debilitating back pain. After being treated with a minimally invasive spinal procedure, called balloon kyphoplasty, she no longer suffers from back pain and is able to walk with the aid of a walker or cane.

Osteoporosis is a disease that leads to fragile bones and an increased susceptibility to fractures of the spine, hip or wrist. The degenerative disease is the main cause of the estimated 1.4 million vertebral compression fractures (VCFs) of the spine suffered annually worldwide that need the attention of a physician.i The International Osteoporosis Foundation is sponsoring World Osteoporosis Day on October 20 with the goal of informing and educating the patients and policy makers about osteoporosis prevention. The day encourages individuals to take steps to improve their bone health.

"World Osteoporosis Day is the ideal occasion to bring attention to this disease that affects an estimated 75 million people in the United States, Japan and Europe," said Alex DiNello, vice president and general manager, KYPHON® products, part of the Spinal and Biologics business at Medtronic. "Mrs. Daniels' positive outcome is further evidence, as supported in a recent studyii, that patients who are treated with balloon kyphoplasty may experience better quality of life, back function and back pain relief than those who undergo only non-surgical management."

Mrs. Daniels sustained two VCFs in December of 2008 and was treated at first with back braces and pain medication by her private care physician, Dr. Rajiv Narula. However, the pain persisted. Dr. Narula referred her to Dr. Kenneth Hansraj, an orthopedic spine specialist with New York Spine Surgery & Rehabilitation Medicine, who performed the balloon kyphoplasty procedure.

During the minimally invasive balloon kyphoplasty procedure that gave Mrs. Daniels relief from her back pain, tiny balloons are inserted into fractured vertebrae and inflated to create a space. The space created by the balloons is filled with a special type of cement to secure the position of the bones.

"Mrs. Daniels is in remarkable health and was an ideal candidate for the procedure," said Dr. Hansraj. "Today Mrs. Daniels reports no back pain, is walking and, most importantly, is enjoying her time with her four sons and eight grandchildren."

For more information on World Osteoporosis Day go to: http://www.iofbonehealth.org
More information on osteoporosis is located at http://www.nof.org.
For more information on balloon kyphoplasty, go to http://www.kyphon.com.
To locate a physician trained in balloon kyphoplasty, go here.

About Balloon Kyphoplasty

During the minimally invasive balloon kyphoplasty procedure, a needle and tube are used to create a small pathway into the fractured bone. Orthopedic balloons are inserted and then inflated inside the fractured bone in an attempt to restore vertebral body height and correct angular deformity. Inflation of the balloons creates cavities in the vertebral body that are filled with bone cement, forming an "internal cast" to support the surrounding bone and prevent further collapse.

More than 500,000 patients worldwide have been treated with balloon kyphoplasty. Balloon kyphoplasty differs from other surgical therapies for VCFs such as vertebroplasty, which is designed to stabilize the fracture without correcting vertebral body deformity or providing a controlled fill for bone cement distribution. With balloon kyphoplasty, inflation of the balloons compacts the cancellous bone, which may fill fracture lines and reduce leak pathways. The presence of the space also allows a more viscous bone cement to be injected under low manual pressure. These features are designed to potentially reduce the risk of leakage.

Risk Statement

The complication rate for KYPHON® Balloon Kyphoplasty is low, but all surgical procedures carry risk. Serious complications may occur, including leakage of bone cement, and in rare instances complications may result in death or paralysis. This procedure is not for everyone. A prescription is required. Please consult your physician for a complete list of indications, benefits, and risks. Only you and your physician can determine whether this procedure is right for you.

About Medtronic's Spinal and Biologics Business

The Spinal and Biologics business is based in Memphis, Tenn. It is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The Spinal and Biologics business works with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic, dental and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle-friendly surgical therapies. More information about the company and its treatment therapies can be found at http://www.medtronic.com and its patient-education Web sites, http://www.back.com , www.iscoliosis.com , http://www.maturespine.com and http://www.necksurgery.com.

Source
Medtronic

Acupuncture Beats Usual Care at Relieving Back Pain

Even simulated acupuncture with a toothpick works, suggesting a possible placebo effect

15 may 2009-- Acupuncture, even simulated acupuncture using a toothpick, outperformed usual care in relieving low back pain according to a study in the May 11 Archives of Internal Medicine.

Daniel C. Cherkin, Ph.D., of the Center for Health Studies in Seattle, and colleagues randomized a group of 638 low back pain patients to receive one of the following four treatments: standardized acupuncture; individualized acupuncture; simulated acupuncture with a toothpick; and usual care consisting of medication and physical therapy. Each acupuncture subject received 10 treatments over a seven-week period. Outcomes were assessed after eight, 26, and 52 weeks in terms of dysfunction scores and a continuing discomfort scale.

After eight weeks, the researchers note that the groups receiving individualized, standardized, and simulated acupuncture improved on the dysfunction scores by 4.4, 4.5, and 4.4 points respectively, while those receiving usual care improved 2.1 points. Symptom improvement in the acupuncture groups was in the range of 1.6 to 1.9 points compared to 0.7 in the usual-care group. At one year, improvement in dysfunction scores was sustained in the acupuncture groups (range 59 to 65 percent versus 50 percent for usual care).

"Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits," the authors conclude. "These findings raise questions about acupuncture's purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects."

Abstract
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Test 'sheds light on back pain'

A simple technique could help doctors differentiate between patients with different causes of back pain and thus improve treatment, a study suggests.

23 april 2009--Researchers writing in PLoS Medicine have devised "bedside" tests which distinguish between neuropathic - nerve damage - and other causes of pain.

Neuropathic pain is commonly described as "burning" or "stabbing" but it is often difficult to formally diagnose.

Back pain is the most commonly cited reason for being absent from work.

A team from Massachusetts General Hospital in the US and Addenbrooke's in the UK recruited more than 300 patients with chronic back pain.

Some had a known history of nerve damage caused by diabetes or shingles, while others had low back pain with or without evidence of spinal nerve root damage.

Question time

By carrying out detailed comparisons of the patients, researchers were able to formulate a set of six questions and 10 physical tests which distinguished between the two groups.

“ Although back pain is very common, in many cases we still have a poor understanding of where the pain is coming from ”
Dries Hettinga BackCare

The results, they said, were superior to existing screening tests for neuropathic pain and even to MRI scanning of the spine, which can be misleading as many people have damage to their spinal discs without any pain.

In most types of neuropathic pain, all signs of any injury have usually disappeared but certain nerves continue to send pain messages to the brain.

Traditional pain killers often do not help - other options include antidepressants, and physical as well as psychological treatment.

"Currently clinicians measure pain only by asking how bad it is, using scales from mild to moderate to severe or asking patients to rate their pain from one to 10," said lead author Joachim Scholz, an assistant professor of anaesthesia.

"This approach misses key characteristics that reflect the mechanisms causing the pain.

"The treatment of neuropathic and nonneuropathic pain is quite different, and if a diagnosis is wrong, patients may receive treatment, including surgery, that does not improve their pain."

Dries Hettinga, head of research & policy at the charity BackCare, said: "Although back pain is very common, in many cases we still have a poor understanding of where the pain is coming from and how to tailor treatments to individual cases.

"This is why the diagnostic tool that the researchers developed could make a big difference to many people with back pain.

"People with neuropathic back pain need a different treatment approach than those with non-neuropathic pain and an accurate and easy to use tool to distinguish the two types of pain would not only benefit people with back pain, but also help to tailor treatments for people with back pain and thus decrease costs."

Different causes of back pain

13 april 2009--“A simple technique could help differentiate patients with different causes of back pain,” suggests BBC News. The new service says that researchers have devised bedside tests that distinguish between neuropathic pain (nerve damage) and other causes of pain. It said the tests are better than existing tests for neuropathic pain. The news service highlighted the importance of this by saying that different causes of pain have different treatments and quoted one of the researchers as saying, “if a diagnosis is wrong, patients may receive treatment, including surgery, that does not improve their pain".

This study indicates that a simple, quick diagnostic procedure can distinguish between the most common cause of back pain (axial) and pain caused by nerve damage (neuropathic). As the treatment for these can be very different, this is potentially a very useful tool. The subjects in this study all had long-term back pain and the tool will need to be tested in a more general population of people with back pain.

Where did the story come from?

The research was carried out by Dr Joachim Scholz from the Massachusetts General Hospital in Boston and colleagues from other institutions in the US, UK and Switzerland. The work was supported by a grant awarded by Pharmacia through The Academic Medicine and Managed Care Forum, with supplementary support from Pfizer. The study was published in the (peer-reviewed) medical journal PLoS medicine, a free journal from the Public Library of Science.

What kind of scientific study was this?

This was a diagnostic test validation study. It had two parts, the first of which involved the researchers devising a set of questions and bedside tests for distinguishing between two different types of back pain: neuropathic and axial. These diagnostic ‘tools’ were then tested on a separate group of participants to measure their accuracy.

Neuropathic pain is caused by damage to the nerves and is often difficult to formally diagnose. Sufferers commonly describe it as a ‘burning’ or ‘stabbing’ pain. A common form of neuropathic pain is ‘radicular’ low back pain, also called sciatica, which comes from a slipped disc and radiates from the back into the legs. The researchers compared this to the most common type of low back pain, ‘axial pain’, which is confined to the lower back and is non-neuropathic (not caused by nerve damage but is due to damage to joints, muscles or other tissue.

In the first part of the study, the researchers recruited 130 patients with several types of peripheral neuropathic pain and 57 patients with axial low back pain. These patients came from physician referrals or had answered advertisements. The patients had chronic back pain, painful diabetic neuropathy or pain following shingles. They were given a structured interview of 16 questions and a bedside examination of 23 tests. The interview involved asking the participants to choose words from a list that described their pain and to grade the intensity of particular aspects of their pain from zero (no pain) to 10 (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration. The patients were divided into smaller groups according to their responses to the interview and tests and statistical modelling was used to identify six questions and 10 physical tests that discriminated best between pain subtypes. The researchers combined these items into a tool that they called the Standardised Evaluation of Pain (StEP) tool.

The second part of the study was conducted at Addenbrooke’s hospital in Cambridge, UK between January 2006 and November 2007. The researchers applied the StEP tool to an independent group of 137 patients with back pain. These people had been recruited using similar methods and inclusion criteria to the first part. This included a requirement that they had moderate or severe back pain (more than six on a scale of zero to 10) for three months or more. Patients with a severe medical or psychiatric illness, another painful disorder or neurological disease were also excluded. The patients were allowed to continue their previously prescribed pain relief treatment during this time.

The StEP tools diagnostic accuracy was measured against clinical diagnosis as a ‘reference standard’. The researchers calculated the sensitivity and specificity of StEP and its positive and negative predictive values for the distinction between radicular and axial back pain.

What were the results of the study?

A number of patients were excluded from the study, including 32 patients in the first part and 11 patients in the second part. Reasons for exclusion were because the duration or intensity of pain did not meet the inclusion criteria, because the patients suffered from other painful disorders or had diseases that would have affected the evaluation of their pain. Another six patients with low back pain were excluded from the validation study because there was no unanimous decision between the attending physicians on the diagnosis.

In the second validation part, the StEP tool correctly identified the type of back pain (radicular or axial) in 129 out of the 137 patients. When a cut-off score of four was used, the tool identified patients with radicular pain with 92% sensitivity, meaning that the test detected 92% of all people with radicular pain, but missed the other 8%. The test had 97% specificity, meaning that it correctly identified 97% of people as having axial pain rather than radicular pain, but 3% of people with axial pain were incorrectly diagnosed as having radicular pain. The tool had a positive predictive value of 97%, i.e. 97% of all people identified by the test as having radicular pain truly had this type of pain.

What interpretations did the researchers draw from these results?

The researchers say that the diagnostic accuracy of the StEP tool “exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging”. They go on to claim that the tool offers a “unique opportunity to improve targeted analgesic treatment”.

Diagnostic studies such as these are rarely reported in the news, though they form an important part of developing any potential test. There are a few points to consider about this study:

• The researchers also looked at the accuracy of the individual examination signs that make up the tool and showed that the best tests were tests for radicular pain known as a straight-leg-raising sign, a test for detecting cold, and a reduced response to pinprick test. The authors note that this is not surprising as they are routine parts of the examination of patients with back pain, and can be a diagnostic criterion of neuropathic pain. How much better this screening tool is than a more usual physical examination, needs further investigation.
• The relevance of this study to a more general population of people with back pain will need to be tested. The participants in this study were included because their back pain had suspected neuropathic causes. As such, they are a selected group and it is probable that the test will not work as well in the unselected populations that would be managed in primary care without referral to a specialist hospital clinic.

These findings indicate that a simple, quick diagnostic procedure can distinguish between radicular (neuropathic) and axial (non-neuropathic) low back pain in the selected group tested. Because the two types of back pain are treated in different ways, this is important when deciding who to refer for further tests such as an MRI scan. More testing of this tool’s diagnostic accuracy in primary care settings such as GPs surgeries would be valuable

Spinal Manipulation Plus NSAID Shows No Benefit for Back Pain

SYDNEY, Australia, Nov. 8 -- Remaining active, avoiding bed rest, and acetaminophen are sufficient treatment for most patients with acute low-back pain, according to researchers here.Adding the nonsteroidal anti-inflammatory drug diclofenac and spinal manipulation to standard care did not speed recovery for patients with acute low-back pain compared with double placebo (HR: 1.10, 95% CI: 0.76 to 1.60, P=0.609), Mark J. Hancock, M.App.Sc., of the of the University of Sydney Back Pain Research Group, and colleagues, reported in the Nov. 10 issue of The Lancet.
Action Points
Explain to interested patients that acute low-back pain usually responds in two weeks to standard treatment, which includes remaining active, avoiding bed rest, and taking acetaminophen.
Explain that this study showed no benefit to spinal manipulation and taking a nonsteroidal anti-inflammatory agent.
Present first-line treatment guidelines recommend that patients remain active, avoid bed rest, receive reassurance of a favorable prognosis, and take paracetamol (acetaminophen in the U.S.), the researchers said.
Nonsteroidal anti-inflammatory drugs and spinal manipulation are recommended as second-line options.
To determine whether adding the NSAID diclofenac and/or spinal manipulation would speed recovery, the investigators studied 240 patients with acute low-back pain who had been seen by their general practitioners and were advised to use standard therapy.
Patients were recruited by 19 physicians from 14 practices from June 2005 through October 2006. They had moderate baseline pain, moderate disability, and low fear avoidance.
In the 12-week, community-based study, all patients were given standard therapy: paracetamol (1g) four times a day until recovery or for a maximum of four weeks, and advice from the physician to remain active and avoid bed rest.
Patients were then randomly assigned to one of four groups: diclofenac 50 mg twice a day and placebo manipulation; spinal manipulation and placebo drug; diclofenac 50 mg twice daily and spinal manipulative therapy; or double placebo (the control group).
The spinal manipulative therapy included a range of low-velocity mobilization and high-velocity manipulation techniques done by physiotherapists with postgraduate training. The median number of therapy sessions per week was 2.3. The placebo therapy was detuned pulsed ultrasound.
The median time to full recovery was about two weeks and was not improved with diclofenac or spinal manipulative therapy.
None of the combinations appreciably reduced the number of days until recovery compared with placebo drug or placebo manipulative therapy (diclofenac HR: 1.09, 95% CI: 0.84 to 1.42, P=0.516; spinal manipulation HR: 1.01, 95% CI: 0.77 to 1.31, P=0.955).
As for the secondary outcomes, neither diclofenac nor manipulation had a statistically significant effect on pain, disability, function, or global perceived effect at any point in the 12-week study, the researchers said.
A systematic review of other studies using NSAIDs, although without prior quality baseline treatment, suggests that results from this trial with diclofenac can be generalized to other NSAIDs, the researchers said.
Although 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness, and heart palpitations, half of these were in the active diclofenac group and the other half was taking a placebo.
One patient taking active diclofenac had a suspected hypersensitivity reaction and ceased treatment.
At present, the active agent in manipulation therapy and the mechanisms of action are unclear. More effective types of manipulation might be possible once mechanisms of action are understood, the investigators said.
A small number of patients (28) had co-interventions during the study, which could have affected the results, the researchers acknowledged, but these interventions were similar in the active and placebo groups.
In addition, they said, compliance rates, although not perfect, were high in both groups and were representative of clinical practice.
This study suggests that these patients can be managed without exposing them to the increased risks and costs associated with NSAIDS or spinal manipulation, the researchers concluded.
In an accompanying comment, Bart W. Koes, Ph.D., of Erasmus University in Rotterdam, The Netherlands, wrote that some would argue that the type of spinal manipulation used in this study (mainly low-velocity mobilization) is not similar to high-velocity thrust techniques.
However, he said, randomized trials and a subsequent Cochrane review suggest that neither low-velocity nor high-velocity techniques have more favorable results than the other.
Additionally, the treatments used in this study were largely similar to the use of spinal manipulative therapy in common daily practice, Dr. Koes said.
The important message, he said, is that the management of acute low-back pain in primary care, namely advice and acetaminophen, is sufficient for most patients.
The trial was funded primarily by Australia's National Health and Medical Research Council. Diclofenac was donated by Alphapharm.
Co-author Richard Day, M.D., noted that he was a member of an advisory board for paracetamol for GlaxoSmithKline but that payments went to an audited hospital account for teaching and research purposes.
Dr. Koes, the comment author, declared no conflicts of interest.
Primary source: The LancetSource reference: Hancock MJ, et al "Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomized controlled trial" The Lancet 2007; 370: 1638-1643. Additional source: The LancetSource reference: Koes BW, "Evidence-based management of acute low back pain" The Lancet 2007; 370: 1595-1596.