Largest ever controlled study of neurostimulation for neuropathic pain reports significant improvements in pain reduction and quality of life compared to medication

PROCESS study findings support the routine consideration of spinal cord stimulation as part of conventional pain management in appropriate patients

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13th September 2007 - A medical device which sends electric signals into the spine can dramatically cut the amount of pain suffered by people with chronic nerve damage, according to research published today in the medical journal Pain. [1]

The study, which gives hope to many of the estimated four million adults in the UK living with pain caused by problems with their nervous system (known as neuropathic pain), [2,3] showed that 48 percent of patients on neurostimulation reported being in half as much pain as before treatment.  By contrast just nine percent of the group who received conventional treatments reported the same level of pain relief (p<0.001).  

In addition, the study, called PROCESS (PROspective randomized Controlled trial of the Effectiveness of Spinal cord Stimulation), showed that neurostimulation therapy in combination with conventional medical management provided patients with significantly greater pain relief, quality of life, functional capacity, and treatment satisfaction than conventional medical management alone after six months.

One of the authors, Dr Sam Eldabe of The James Cook University Hospital in Middlesbrough, commented: “In the UK, neurostimulation for chronic pain is under used.  This study, however, provides a compelling argument for adding neurostimulation to the list of treatments routinely considered for appropriate patients.”

Neurostimulation therapy uses an implantable medical device to deliver electrical pulses which block pain signals in the spinal cord.  In the study, conventional medical management included oral medications, nerve blocks, steroids, physiotherapy, psychotherapy and chiropractic care.

Lead author Dr Krishna Kumar, chairman of the neurosurgery department at the University of Saskatchewan’s Regina General Hospital in Canada said, “Patients with persistently disabling neuropathic pain in the back and legs represent one of the most difficult treatment problems in clinical practice.

“Our findings show that neurostimulation offers patients in this situation a treatment option that can relieve their pain to a significantly greater degree than conventional medical management alone – and, as a result, helps restore quality of life and functional capacity as well.” 

The largest ever prospective study of neurostimulation therapy, PROCESS is also the first to employ a multi-center randomized controlled design, the gold standard for clinical trials.  It randomly assigned 100 patients from 12 academic medical centers in Australia, Belgium, Canada, Israel, Italy, Spain, Switzerland, and the UK to receive conventional medical management (CMM) with or without Medtronic neurostimulation for a period of 24 months. 

All 100 patients in the study had undergone at least one anatomically successful spine surgery for a herniated disk but continued to experience moderate to severe pain in one or both legs, and to a lesser degree in the back, at least six months later.  They were not considered candidates for additional spine surgery.  Their pain resulted from nerve damage due to an untreated or long-standing spinal nerve compression, or from a complicated spine surgery involving a difficult decompression technique.  At the start of the trial their pain had significantly diminished their quality of life which was comparable to that of patients with heart failure or terminal cancer.

Patients in both groups experienced non-device related events, however, drug side effects were reported with significantly greater frequency in the CMM group (21 percent) compared to the SCS group (4 percent).  The most common adverse events associated with neurostimulation therapy in the study were electrode migration and infection.

Associated with nerve damage or nervous system dysfunction, neuropathic pain affects up to eight percent of the population but is often under-diagnosed and under-treated.  Of all pain types, it is among the most severe, chronic, disabling, costly, and difficult to treat. Neuropathic pain most commonly affects the back and legs.

“Medtronic offers a range of effective treatment options for people with chronic pain, from minimally invasive spine surgery to neurostimulation and intrathecal drug therapy,” said Dr Richard E Kuntz, MD, senior vice president of Medtronic, Inc., and president of the company’s Neuromodulation business. “We remain committed to making investments across the company in clinical research and product development for the benefit of people with chronic pain and their physicians.”

Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses, pharmaceuticals, and biologics to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

- ends -

Note to editors

PDF copies of the clinical paper are available freely on request.  Please contact:

- Laura Gardner: 020 7331 5336

- Delphine van der Pauw: 020 7331 2309

References


1                     Kumar K, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain (2007), doi:10.1016/j.pain.2007.07.028.

2                     Torrance N et al.  The epidemiology of chronic pain of predominantly neuropathic origin.  Results from a general population survey.  Pain 2006;7(4):281-289

3                     Office of National Statistics, Mid 2006 population estimates, United Kingdom.  http://www.statistics.gov.uk/statbase/Expodata/Spreadsheets/D9657.xls.  Last accessed 7th September 2007

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 28, 2006.  Actual results may differ materially from anticipated results.

Healthcare Republic does not have an editorial influence or input in to these press releases. The views expressed within these documents are not endorsed by Healthcare Republic or Haymarket Medical Publications Limited.

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