EMBARGOED FOR RELEASE ON APRIL 16
WASHINGTON (April 16, 2007) - An estimated 5,600 people
in the United States are diagnosed every year with Amyotrophic Lateral Sclerosis
(ALS), also known as Lou Gehrig's disease, and as many as 30,000 Americans
have the disease at any given time. Unfortunately, there is no cure for ALS,
and it leads to death most typically two to five years after diagnosis. One
of the side effects of ALS is spasticity, a condition resulting from excess
motor neuron excitation due to lesions in the upper motor neuron pathway that
lead to the absence of inhibition of alpha and/or gamma motor neurons. Spasticity
can cause uncontrollable and often painful muscle contractions. Although the
pain associated with spasticity can usually be controlled with medication and
physical therapy, some patients are unresponsive to this treatment.
Researchers at the University of Minnesota Medical School and the Cleveland
Clinic explored the efficacy of treating ALS patients with intractable spasm-related
pain with an intrathecal baclofen (ITB) pump. Eight patients were implanted
with the ITB pump between January 2003 and December 2005 at the Cleveland Clinic.
The results of this study, Intrathecal Baclofen for Spasticity-Related
Pain in Amyotrophic Lateral Sclerosis: Efficacy and Factors Associated with
Pain Relief , will be presented by Shearwood McClelland III, MD, 3:57
to 4:09 p.m. on Tuesday, April 17, 2007, during the 75th Annual Meeting of
the American Association of Neurological Surgeons in Washington, D.C. Co-authors
are Francois A. Bethoux MD, Matthew H. Sutliff, PT, Darlene K. Stough RN,
Kathleen M. Schwetz, RN, Danuta M. Gogol, RN, Michelle Harrison, PT, Erik
P. Pioro, MD, PhD, and Nicholas M. Boulis, MD.
Patients were selected by the operating surgeon and neurologists specializing
in the treatment of ALS on the basis of a history of longstanding ALS-associated
spasticity, despite optimal medication management. Following successful test
injection, patients were referred to the Cleveland Clinic Center for Neurological
Restoration for programmable ITB implantation.
- The eight patients ranged in age from 33 to 77, with a mean age of 43.8
at surgery.
- The duration of the patients’ ALS symptoms ranged from 14 to 108
months, with an average of 47.4 months at surgery.
- Both pre- and postoperative pain was quantified using a 0-10 scale, with
0 representing no pain and 10 representing maximum pain.
- The mean modified preoperative pain score was 7.69, ranging from 6 to
10.
Following surgery, patients were transferred to an inpatient rehabilitation
unit before eventually returning home with continuing outpatient or in-home
rehabilitation. Patients were subsequently followed by the ALS and related
disorders team at the Cleveland Clinic for ITB pump adjustments and refills.
Mean follow-up was 9.8 months.
The following outcomes were noted:
- Following ITB pump placement, the average pain score was 3.56 (range =
0 to 8), a reduction of 54 percent from preoperative scores.
- No patients experienced neurological morbidity or mortality.
- Six patients (75 percent) experienced pain relief, of which three received
complete pain relief (postoperative pain score of 0).
“The degree of pain relief following preoperative ITB test injection
correlated with the degree of postoperative pain relief following ITB implantation,” stated
Dr. McClelland. The two patients who did not experience pain relief from implantation
were the same patients who failed to experience pain relief from preoperative
ITB test injection. The three patients who experienced complete pain relief
also experienced complete pain relief following preoperative ITB.
“These results support ITB as a treatment modality for pain associated
with refractory spastic ALS, and underscore the importance of pain documentation
following preoperative ITB test injection. In appropriately selected ALS patients
with spasticity, ITB implantation can offer a significant quality of life improvement
for an incurable and often painful condition,” concluded Dr. McClelland.
Founded in 1931 as the Harvey Cushing Society, the American Association of
Neurological Surgeons (AANS) is a scientific and educational association with
more than 6,800 members worldwide. The AANS is dedicated to advancing the specialty
of neurological surgery in order to provide the highest quality of neurosurgical
care to the public. All active members of the AANS are certified by the American
Board of Neurological Surgery, the Royal College of Physicians and Surgeons
(Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC.
Neurological surgery is the medical specialty concerned with the prevention,
diagnosis, treatment and rehabilitation of disorders that affect the entire
nervous system, including the spinal column, spinal cord, brain and peripheral
nerves.
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Media Representatives: If you would like to cover
the meeting or interview a neurosurgeon - either on-site or via telephone -
please contact the AANS Communications Department at
(847) 378-0517 or call
the Annual Meeting Press Room beginning Monday, April 16 at
(202) 249-4010.
