Evaluating intrathecal delivery system
Here are reports on two research studies concerning baclofen – the first where it was found that long-term treatment with intrathecal compared with oral baclofen resulted in reduced spasm frequency and severity as well as greater dose stability, however no significant differences were found in pain, sleep, fatigue and quality of life measures between people taking either of the two.
.
The second was a large study that effectively used CT scans to locate defects in intrathecal baclofen delivery systems. On this second study, Dr. Malin Dollinger, a medical practitioner who has HSP said “This is a very good article. I think everyone with a Baclofen pump should have a copy to show their pump doctor if there is ever any drug delivery problem. The average x-ray department may not have specific experience with CT scans of Baclofen pumps, and this article is a good guide.”
Abstract
BACKGROUND: Baclofen commonly is used to manage spasticity caused by central nervous system lesions or dysfunction. Although both intrathecal and oral delivery routes are possible, no study has directly compared clinical outcomes associated with these 2 routes of treatment.
OBJECTIVE: To compare spasticity levels, pain, sleep, fatigue, and quality of life between individuals receiving treatment with intrathecal versus oral baclofen.
DESIGN: Cross-sectional matched cohort survey study.
SETTING: Urban academic rehabilitation outpatient clinics.
PARTICIPANTS: Adult patients with spasticity, treated with intrathecal or oral baclofen for at least 1 year, matched 1:1 for age, gender, and diagnosis.
METHODS: Standardized surveys were administered during clinic appointments or by telephone.
MAIN OUTCOME MEASURES: Surveys included the Penn Spasm Frequency Scale, Brief Pain Inventory, Epworth Sleepiness Scale, Fatigue Severity Scale, Life Satisfaction Questionnaire, and Diener Satisfaction with Life Scale.
RESULTS: A total of 62 matched subjects were enrolled. The mean (standard deviation [SD]) age was 46 (11) years with a mean duration of intrathecal baclofen or oral baclofen treatment of 11 (6) and 13 (11) years, respectively. There were 40 (64%) male and 22 (36%) female subjects. Primary diagnoses included spinal cord injury (n = 38), cerebral palsy (n = 10), stroke (n = 10), and multiple sclerosis (n = 4). The mean (SD) dose of intrathecal and oral baclofen at the time of survey were 577 (1429) μg/day and 86 (50) mg/day, respectively. Patients receiving intrathecal compared with oral baclofen experienced significantly fewer (1.44 [0.92] versus 2.37 [1.12]) and less severe (1.44 [0.92] versus 2.16 [0.83]) spasms, respectively as measured by the Penn Spasm Frequency Scale (P < .01; P < .01).
There were no significant differences in pain, sleep, fatigue, and quality of life between groups. Subanalysis of patients with SCI mirrored results of the entire study sample, with significant decreases in spasm frequency and severity associated with intrathecal compared to oral baclofen (P < .01; P < .01), but no other between group differences. The mean (SD) percent change in dose of oral (21% [33%]) compared with intrathecal (3% [28%]) baclofen was significantly larger two years prior to the date of survey (P = .02).
CONCLUSIONS: Long-term treatment with intrathecal compared with oral baclofen is associated with reduced spasm frequency and severity as well as greater dose stability. These benefits must be weighed against the risks of internal pump and catheter placement in patients considering intrathecal baclofen therapy.
SOURCE: PM R. 2016 Jun;8(6):553-62. doi: 10.1016/j.pmrj.2015.10.005. Epub 2015 Oct 20.
Intrathecal Versus Oral Baclofen: A Matched Cohort Study of Spasticity, Pain, Sleep, Fatigue, and Quality of Life.
McCormick ZL1, Chu SK2, Binler D3, Neudorf D4, Mathur SN5, Lee J6, Marciniak C7.
1 Department of Physical Medicine & Rehabilitation (PM&R), Northwestern Feinberg School of Medicine/The Rehabilitation Institute of Chicago, McGaw Medical Center, Northwestern University Feinberg School of Medicine, 345 East Superior Street, Chicago, IL 60605(∗). Electronic address: [email protected].
2 Department of Physical Medicine & Rehabilitation (PM&R), Northwestern Feinberg School of Medicine/The Rehabilitation Institute of Chicago, Chicago, IL(†).
3 Rush University School of Medicine, Chicago, IL(‡).
4 Department of PM&R, University of California at Davis, Sacramento, CA(§).
5 Case Western Reserve University School of Medicine, Cleveland, OH(¶).
6 Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL(#).
7 Department of Physical Medicine & Rehabilitation (PM&R), Northwestern Feinberg School of Medicine/The Rehabilitation Institute of Chicago, Chicago, IL(‖).
Abstract
AIM: To describe the computed tomography (CT) findings encountered when catheter patency is questionable. The role of CT in directing treatment is evaluated.
METHOD: Records of children with intrathecal baclofen pump management were reviewed. Only patients with CT evaluation who had revision pump/catheter surgery were included.
RESULTS: From 295 patients, 27 had CT contrast study; in three of them, baclofen could not be aspirated and the procedure was stopped, eight had normal scan and did not need surgery and 16 patients were reported. Four patients had normal CT (free contrast formed a perfect crescent shape), and had surgery because the pump battery was close to expiration. Five patients had inadequate fluid pooling (fluid was seen without a crescent shape). Five patients had fluid leak (fluid was seen around the pump or in the lumbar canal below catheter entrance level or outside the canal in the lumbar region). Two patients had catheter occlusion (fluid loculation around the catheter tip with no free flow).
INTERPRETATION: CT contrast study is safe and effective for locating defects in intrathecal baclofen delivery system. When catheter patency is questionable, CT plays an important role in directing the next step of management.
SOURCE: Dev Med Child Neurol. 2016 Apr;58(4):409-15. doi: 10.1111/dmcn.12893. Epub 2015 Sep 11.
Evaluation of intrathecal baclofen delivery system malfunction by computed tomography scan.
Abousamra O1, Rogers KJ1, McManus M1, Miller F1, Sees JP1.
1 Department of Orthopedics, Nemours/Alfred I. duPont Hospital for Children, Wilmington, DE, USA.
Hi I am a 60 year old male and I have been diagnosed with HSP about 2half years ago . I was wondering if is better to have a pump or just take take tablets ? As my doctor is wanting me to get pump ?