Neurostimulation Provides Sustained Leg Pain Relief, Improved Quality Of Life An

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Neurostimulation Provides Sustained Leg Pain Relief, Improved Quality

Of Life And Functional Capacity, Study

http://www.medicalnewstoday.com/articles/128556.php

New 24-month data from a study published today in the scientific

journal, Neurosurgery, show that spinal cord stimulation

(neurostimulation therapy) provides sustained, significant

improvement in otherwise intractable, chronic leg pain, quality of

life and functional capacity out to 24 months of therapy. Supported

by Medtronic, Inc. (NYSE: MDT), this largest randomized, controlled

neurostimulation study followed patients with chronic neuropathic leg

and back pain who received spinal cord stimulation therapy along with

conventional medical management to compare the results to patients

who received conventional medical management alone. While the 24 & #8208;

month data are newly published, earlier data points from this

clinical trial provided critical evidence used for the U.K.'s

National Institute for Health and Clinical Excellence (NICE) final

guidance, which recommends access to spinal cord stimulation therapy

for patients in the United Kingdom. The updated NICE guidance

concluded that the use of neurostimulation for chronic neuropathic

pain is safe and effective, as well as cost & #8208;effective.

Spinal cord stimulation therapy uses an implantable medical device

similar to a pacemaker to deliver electrical pulses to the epidural

space in order to interrupt pain signals traveling through the

nervous system from reaching the brain.

The newly published 24 & #8208;month results from the study, known as PROCESS

(for PROspective randomized Controlled trial of the Effectiveness of

Spinal cord Stimulation), showed positive results are sustained in

patients who received Medtronic neurostimulation therapy plus

conventional treatments at 24 months:

-- Of the 42 patients who were in the neurostimulation group from the

start of the study and continued on at 24 months, 69 percent

experienced a clinically significant (at least 30 percent)

improvement in leg pain relief and 40 percent had a sustained 50

percent or greater improvement in leg pain relief based on the study

pain scale.

-- Of all 72 patients receiving neurostimulation plus conventional

medical management at the 24 & #8208;month study visit, including the 30 who

opted to cross over from the conventional medical management alone

group, 47 percent achieved 50 percent or greater improvement in the

leg pain relief threshold versus only 7 percent of those receiving

conventional medical management alone.

A surgical procedure was needed to resolve adverse events in 13 of

the 42 patients randomized to neurostimulation who continued to

receive stimulation at 24 months. As noted in the study report, the

complications were benign and reversible and included electrode

migration, infection and loss of paresthesia (a tingling sensation

that is felt when the electrical stimulation is being delivered).

" The PROCESS study is the largest, randomized study of spinal cord

stimulation published to date that shows the long & #8208;term potential for

neurostimulation therapy in treating chronic and debilitating leg

pain, " said North, M.D., neurosurgeon at Lifebridge Health

Brain and Spine Institute and Professor of Neurosurgery,

Anesthesiology and Critical Care Medicine (ret.) at s Hopkins in

Baltimore, land. Dr. North is a senior author on the paper and a

member of the Steering Committee that was responsible for managing

the PROCESS study design. " Our findings out to 24 & #8208;months show that

the benefits of neurostimulation therapy can be sustained for a long

period of time without diminishing effectiveness. These results

complement those of studies finding that carefully selected patients

experience leg and back pain relief with neurostimulation. This

therapy offers hope for patients whose activities are limited as a

result of chronic pain that is not responsive to common treatments. "

PROCESS Study Design

The PROCESS study design randomly assigned 100 patients from 12

academic medical centers in Australia, Belgium, Canada, Israel,

Italy, Spain, Switzerland, and the United Kingdom to receive

conventional medical management alone or in combination with

Medtronic neurostimulation therapy for a period of six months, with

long & #8208;term follow & #8208;up to 24 months. Conventional medical therapies

included oral medications, nerve blocks, steroid injections, physical

and psychological therapy and/or chiropractic care. After six months,

patients could request to cross over to the alternate treatment

group.

The study's primary end point was the proportion of patients in each

group reporting an improvement of leg pain relief of at least 50

percent at six months. Secondary outcomes included improvement in

back pain, health & #8208;related quality of life and functional capacity;

patient treatment satisfaction, change in use of pain therapies

(pharmacological and non & #8208;pharmacological); and the frequency and

nature of adverse events. All 100 patients in the study had undergone

at least one previous 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.

About the U.K.'s NICE Guidance

NICE is an independent organization responsible for providing

national guidance in the United Kingdom on the promotion of good

health and the prevention and treatment of ill health. All clinical

evidence included in the NICE systematic review was developed with

Medtronic neurostimulation systems (403 devices used). The new

guidance from NICE is good news for patients since it recommends that

neurostimulation should be available to all patients who continue to

experience chronic neuropathic pain for at least six months despite

trying conventional approaches to pain management. Patients will also

be required to have had a successful trial of the therapy before a

spinal cord stimulator is implanted. NICE has not recommended spinal

cord stimulation for people with ischemic pain, ruling out the

treatment for people experiencing chronic pain caused by conditions

such as refractory angina and critical limb ischemia, except in the

context of research as part of a clinical trial.

" In the growing field of Neuromodulation, Medtronic remains uniquely

committed to investing in Class I clinical evidence that is critical

for patients, physicians, physician societies and healthcare payers, "

said E. Kuntz, M.D., senior vice president and president of

the Neuromodulation business at Medtronic. " Our product development

is aimed at providing durable successful therapies, as measured in

these clinical studies, for the benefit of people with chronic pain

and their physicians. Our leadership is focused on all aspects of

neurostimulation therapy for chronic pain, including ensuring

evidence is available for important guidance decisions from worldwide

authorities to also offering the largest portfolio of rechargeable

and non & #8208;rechargeable devices and leads to meet patient needs. "

Along with advancing clinical evidence in support of

neurostimulation, Medtronic has also introduced recent innovations in

technology. The latest advance is the RestoreULTRA® neurostimulation

system, which offers an unparalleled advance as Medtronic's smallest

and thinnest 16 & #8208;electrode, rechargeable neurostimulator. It also is

the only system on the market to offer a patient programmer that

allows patients to customize and adjust their own stimulation up and

down the spine to maximize their pain relief.

About Neuropathic Pain

Associated with nerve damage or nervous system disease, 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.