Clinical Evidence in Spastic Hypertonia Associated with Multiple Sclerosis

Sadiq SA, Wang GC. Long-term intrathecal baclofen therapy in ambulatory patients with spasticity. J Neurol. 2006;253(5):563-569. Epub 2005 Nov 22.

Methods

• N = 36 patients with spasticity (27 of those had MS)
• Patients had suboptimal response to oral anti-spasmodic medications or were intolerant of oral medications
• Retrospective study
• Follow-up period 1 to 13 years
• Patient age range: 19 to 66

Results

• All patients had reduced spasticity following screening test and pump implantation
• All patients retained ambulatory status in the first 6 months (3 eventually became paraplegic related to underlying disease progression)
• 9 patients, all followed for more than 2 years post-implant, have sustained and improved ambulatory function
• 94% of patients retrospectively stated they would receive the therapy again and were overall improved
• ITB Therapy relieved spasticity-related pain in all 16 patients who reported having this symptom
• Catheter complications occurred in 8 of the 36 patients:
• 2 were associated with a catheter malfunction
• 6 were associated with surgical technique
• 3 patients had unique complications:
• 1 developed a pseudomeningocele which was resolved by repair and catheter replacement
• 1 had pump site discomfort and severe pain from pump placement which was resolved at pump replacement due to end of battery life
• 1 had cystic swelling around the pump site which was resolved when the pump and catheter were replaced

Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G. A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Arch Phys Med Rehabil. 2005;86(11):2165- 2171.

Methods

• 138 patients with severe spasticity of cerebral or spinal origin; 129 were implanted (41 had MS)
• Non-comparative, multicenter, prospective cohort trial
• Follow-up at 3, 6, 9, and 12 months
• Patient age range: 4 to 74

Results

• For patients with spinal origin spasticity, Ashworth scores decreased:
• In lower extremities from 3.68 ± 0.81 to 1.92 ± 0.75 (p < 0.001)
• In upper extremities from 1.65 ± 0.78 to 1.34 ± 0.50 (p < 0.001)
• Significant decreases in spasm scores from baseline to 12 months from 2.70 ± 1.24 to 0.97 ± 0.95 (p < 0.001)
• Improvement in motor function was observed at 12 months (p < 0.001) and in cognitive function at 3 months (p = 0.01) 
• Performance and satisfaction in selected occupational tasks as measured by the COPM showed improvement (p < 0.001)
• 87% of physicians rated their overall satisfaction as good or very good, 8% fair, and 5% poor or very poor
• 10% of patients experienced surgery-related adverse events, including cerebrospinal fluid leak (1), catheter dislodgement during surgery (1), spinal headache (1), drug adverse effect (1), meningitis (1), leg pain (1), hematoma (2), incontinence (2) and pocket wound infection (3)
• 9% of patients experienced catheter-related events, including catheter dislodgement (4), catheter kink (3), catheter occlusion (1), pocket seroma (1), underinfusion (1), and spinal headache (1)
• 43% of the patients who underwent pump implantation reported at least 1 adverse event during the 12 months of follow-up
• 5 patient deaths occurred and were unrelated to ITB Therapy

Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10(5):589-595.

Methods

• 2 groups:
• Cross-sectional survey of patients enrolled in the NARCOMS (North American Research Committee on MS) patient registry
• 2 to 1 control of a survey of registry patients receiving ITB Therapy (N=198) and randomly selected non-ITB Therapy (N=315) registrants

Results

• Out of the total registry, 16% of patients reported no spasticity, 31% reported minimal spasticity, 19% reported mild/occasional spasticity, 17% reported moderate spasticity, 13% reported severe spasticity, and 4% reported total spasticity
• Relapses in MS symptoms were more likely with oral medication than with ITB Therapy (43% versus 31%), yet duration of disease was similar in the 2 groups
• The Patient Determined Disease Steps score increased with the severity of spasticity paralleling gait disability, as well as the handicap scores for all neurological functions measured with the performance scales
• Odds of suffering severe/total spasticity were found to be significantly associated with demographic factors, MS disease type, and related disabilities as determined by scores on the performance scales
• Odds of experiencing severe spasticity are highest for each level of increase in overall disability in pain, bladder dysfunction, mobility, and hand function disability
• ITB group patients are similar to patients with high levels of spasticity in the overall registry
• ITB group reported less stiffness and leg pain due to spasms and a lower number of spasms during the day and night
• Adverse events and system complications were not reported in this article

Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromod. 2002;5(1):16-24.

Methods

• N = 152 patients with severe spasticity of spinal origin; 131 implanted (63 of those implanted had MS)
• All failed to respond to oral antispasmodic medications, became refractory to medical treatment, or developed intolerable side effects
• Double blind randomized placebo control trial for the first 9 patients
• Follow-up period 2 to 137 months (mean 73 months)
• Patient age range: 17 to 73

Results

• Pre-op to post-op mean Ashworth score: 4.2 to 1.3 (p < 0.0005)
• Pre-op to post-op mean Spasm score: 3.4 to 0.6 (p < 0.0005)
• 18 ambulatory patients had improvement in their gait and balance and 2 previously non-ambulatory patients were able to walk
• Pre-op and post-op urodynamic studies in 8 patients demonstrated reduced detrusor hypereflexia and bladder-sphincter dyssynergy and increased bladder capacity
• 10 patients developed a spinal-type headache following the screening test, 6 developed a spinal headache post-surgery, 12 patients had worsened constipation, and 7 patients experienced hypotonia
• 24 catheter problems occurred in 19 patients, 12 occlusions and kinks, 8 breaks
• 1 patient developed bacterial meningitis
• 10 patients died during follow-up, none of which were attributable to ITB Therapy

Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni M. Functional improvement in patients with severe spinal spasticity treated with chronic intrathecal baclofen infusion. Funct Neurol. 2001;16(4):311- 315.

Methods

• 20 non-ambulatory patients with severe spasticity of spinal origin (13 with MS)
• All unresponsive to medical therapy
• Retrospective study
• Follow-up period 12 to 36 months (mean 22.4 months)
• Patient age range: 27 to 52

Results

• Ashworth scores decreased from 4.4 ± 0.5 to 1.8 ± 0.7 (p < 0.01)
• Spasm Frequency Scale (in 13 patients) decreased from 2.5 ± 0.8 to 0.5 ± 0.4 (p < 0.01)
• Self-reported pain scores decreased from 2.5 ± 2.2 to 2.3 ± 1.9 (p < 0.05)
• Statistically significant improvements in Functional Independence Measure scores:
• Increase from mean of 33.8 ± 6.9 to 58.7 ± 10.4 (p < 0.05)
• Improvements mainly in bathing, dressing lower body, and transfers
• FIM score improvements in patients with tetraparesis was only slight
• No drug-related adverse events were reported
• 1 patient experienced CSF leak around the catheter, which required surgical repair

Ordia JI, Fischer E, Adamski E, Spatz EL. Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity. J Neurosurg. 1996;85(3):452-457.

Methods

• N = 66 with severe spasticity of spinal origin, 59 implanted (26 of those implanted had MS)
• Medical treatment failed in all patients
• Follow-up period 23 to 70 months (mean 42 months)
• Patient age range: 16 to 73

Results

• All responded positively to the bolus (screening) dose of ITB Therapy
• Mean Ashworth score decreased from 4.3 pre-operatively to 1.4 at last follow-up (p < 0.0005)
• Spasm score decreased from 3.6 to 0.5 (p < 0.0005)
• Several patients found that activities of daily living such as transferring from wheelchair to bed were easier to accomplish
• Muscle aches and pain, sleeplessness, and overall misery associated with uncontrolled spasms were considerably improved
• Reduction in average length of hospitalization during the first year after the pump was implanted, but no change in overall utilization of outpatient resources
• Net reduction in hospital days was 27 for an average reduction of 2.7 days per patient
• 6 patients with pre-existing constipation were more symptomatic post-surgery; all responded to a bowel regimen. 3 ambulatory patients experienced muscular hypotonia. 3 patients experienced urinary retention
• Catheter-related problems occurred 19 times in 15 patients, including 7 breaks in 5 patients, 9 occlusions, 2 punctures, and 1 dislodgement
• 2 pumps were explanted, 1 due to infection in the pump pocket, and 1 was removed due to skin erosion
• 2 patient deaths occurred, neither related to ITB Therapy

Coffey RJ, Cahill D, Steers W, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(2):226-232.

Methods

• N  =  93 adults with severe spasticity of spinal origin; 75 implanted (27 of those implanted had MS)
• Randomized, double-blind, placebo-controlled screening protocol
• Long-term multicenter study
• Follow-up period 5 to 41 months (mean 19 months)
• Patient age range: 19 to 69

Results

• Decrease in Ashworth (AS) scores (pre-op to post-op mean AS: 3.9 to 1.7)
• No significant difference between patients with MS versus SCI
• Decrease in Spasm (SS) scores (pre-op to to post-op mean SS: 3.1 to 1.0)
• No significant difference between patients with MS versus SCI
• 11 patients experienced drug-related complications including hypotension, seizure, and depression; 6 patients developed an episode of suspected tolerance
• 22 catheter malfunctions in 18 patients (dislodgement, kink, disconnect, and occlusion)
• 3 deaths of unknown cause
• 3 mechanical failures required removal and pump replacement

Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77(2):236-240.

Methods

• N = 66
• Patients with severe spasticity and/or spasms of spinal origin; 62 implanted (32 of those implanted had MS)
• All failed oral anti-spasmodic drug therapy
• Prospective study
• Follow-up period averaged 30 months
• Patient age range: 10 to 71

Results

• 64/66 (97%) patients screened responded with a reduction in Ashworth scale and/or spasm scale scores of 2 points or more
• 3 patients had recurrence of spasms or rigidity after 2, 3, and 3.5 years of successful management in spite of verified drug delivery to the lumbar space
• Therapy well-tolerated
• Transient side effects reported in 31 patients; most common side effects were drowsiness (22), dizziness (10), blurred vision (10), and slurred speech (6); side effects were managed with dose adjustments
• 1 MS patient experienced grand mal seizures
• 25 catheter malfunctions
• Pump failed in 7% of cases resulting in cessation of baclofen delivery
• 5 procedural complications occurred
• 4 patient deaths unrelated to ITB Therapy

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