Intrathecal Versus Oral Baclofen: A Matched Cohort Study of Spasticity, Pain, Sleep, Fatigue, and Quality of Life

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 ¼ 38), cerebral palsy (n ¼ 10), stroke (n ¼ 10), and multiple sclerosis (n ¼ 4). The mean (SD) dose of intrathecal and oral baclofen at the time of survey were 577 (1429) mg/day and 86 (50) 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 ¼ .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.

Long‐Term Dosing of Intrathecal Baclofen in the Treatment of Spasticity After Acquired Brain Injury

“…Previous studies have demonstrated dose stability by calculating the mean change in dose annually in years before the study [16,17]. The mean percent change in dose in the present cohort was not consistent with previous descriptions of minimal dose changes with long‐term use of ITB.…”

“…The mean percent change in dose in the present cohort was not consistent with previous descriptions of minimal dose changes with long‐term use of ITB. One previous study reported mean percent changes in ITB doses of 3%, 3%, and 5% in 1 year, 2 years, and 3 years before time of study, respectively [17]; however, this previous study included a more heterogeneous population with a longer duration of therapy (mean 11 years) and was primarily composed of subjects with spasticity of spinal origin [17]. The mean percent dose changes in the present cohort were 7%, 13%, and 25% over the same period, suggesting of less dose stability in the acquired brain injury population.…”

Blessing or burden? Long‐term maintenance, complications and clinical outcome of intrathecal baclofen pumps

“…4 In fact, McCormick et al showed that, although long-term use of intrathecal baclofen had a significant reduction in spasticity as compared to oral baclofen, there were no significant differences in pain, sleep, fatigue and quality of life. 8 Our study specifically analysed the average time spent for each patient to refill the baclofen pump in a hospital-based setting. We hope this study can fill the gap in the literature, as this information was not readily available during counselling for patients before the operation.…”

Ethical Issues Surrounding a New Generation of Neuroprostheses for Patients With Spinal Cord Injuries

“…Any such off‐target effects would likely be held to the same standard of reaching some minimal clinically important difference regarding outcomes. Although targeted trials could be designed to quantify these off‐target effects, it is notoriously difficult to generate consistent data about many rehabilitation medicine outcomes, such as spasticity, within an often heterogeneous, small patient population [23,24]. For many of these difficult to objectively quantify realms, the intrinsic mechanisms contributing to their varied clinical presentations are likely insufficiently understood (at least to the degree needed to predict outcomes from the host of altered contributory neural signals).…”