QL18
Assessing the Efficacy of Intrathecal Baclofen Therapy in Ambulatory and Non-Ambulatory Patients
Spasticity is a common symptom of multiple sclerosis (MS) that causes muscle stiffness and painful muscle spasms, impaired ambulation, and pronounced issues with activities of daily living. Intrathecal Baclofen (ITB) therapy is a treatment option for severe spasticity refractory to oral medications. There is a dearth of long-term studies assessing ITB efficacy in both ambulatory and non-ambulatory MS patients.
Objectives:
This case series evaluated the outcomes of MS patients with medically intractable spasticity treated with ITB over at least 3 years to determine efficacy outcomes and assess differences between ambulatory and non-ambulatory patients.
Methods:
Patients were identified from an IRB-approved clinical registry. Clinical encounter data was extracted from the registry and electronic medical records. All MS patients who had undergone implantation of an ITB pump between 2001 and 2014 and had follow-up data for at least 3 years and up to 5 years were included. The following outcome measures were collected: pain Numeric Rating Scale (NRS), Modified Ashworth Scale (MAS), and Timed 25 Foot Walk (T25FW).
Results:
We included 77 patients (40 ambulatory and 37 non-ambulatory). Age (mean (SD)) at the time of surgery was 47.1 (9.8) years, and 62.3% were female. Disease course was 5.2% relapsing, 88.3% progressive, and 6.5% unknown. Disease duration was 16.5 (8.5) years. Baseline median (inter-quartile range, IQR) lower extremity MAS score (sum of 8 lower extremity muscle groups) was 18 (12-24), and NRS pain score was 5 (0-7); within ambulatory patients, T25FW was 25.4 (23.7) seconds (assistive device: 20% none, 27.5% cane, 47.5% walker, and 5% unknown). Statistically significant improvement in MAS scores at all follow-up times was observed in the whole sample and in both groups: for ambulatory patients, MAS score was 14.5 (10.8-20.25) at baseline and 2 (0-8) after 5 years on ITB therapy; in non-ambulatory patients, 24 (16.5-26), and 2 (0-5). Pain scores improved significantly between baseline and all follow-up visits in the whole sample and within the non-ambulatory group.
Conclusions:
Our findings suggest that, regardless of ambulatory status, ITB therapy provides long-term reductions in spasticity (as measured by the MAS) regardless of baseline ambulation status. Pain reduction appears more consistent in non-ambulatory patients. Further study is needed to clarify the effects of ITB on other relevant parameters such as strength and quality of life.