- Department of Neurosciences, Division of Neurosurgery, King Faisal Specialist Hospital and Research Centre, Alfaisal University, Riyadh, Saudi Arabia
- College of Medicine, Alfaisal University, Riyadh, Saudi Arabia
- Department of Neurosurgery, Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
Department of Neurosciences, Division of Neurosurgery, King Faisal Specialist Hospital and Research Centre, Alfaisal University, Riyadh, Saudi Arabia
College of Medicine, Alfaisal University, Riyadh, Saudi Arabia
Department of Neurosurgery, Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia
DOI:10.4103/2152-7806.187529Copyright: © 2016 Surgical Neurology International This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
How to cite this article: Abou Al-Shaar H, Alkhani A. Intrathecal baclofen therapy for spasticity: A compliance-based study to indicate effectiveness. Surg Neurol Int 02-Aug-2016;7:S539-41.
How to cite this URL: Abou Al-Shaar H, Alkhani A. Intrathecal baclofen therapy for spasticity: A compliance-based study to indicate effectiveness. Surg Neurol Int 02-Aug-2016;7:. Available from: http://surgicalneurologyint.com/surgicalint_articles/intrathecal-baclofen-therapy-for-spasticity-a-compliance-based-study-to-indicate-effectiveness/
Background:Intrathecal baclofen (ITB) therapy using a programmable battery-based pump is a well-recognized option in the treatment of patients with refractory spasticity. Improvements in clinical scale scores for muscle spasticity among this heterogeneous group of patients may not reflect the functional benefits of this therapeutic option. The aim of our study is to report the efficacy of ITB therapy by setting the patient's compliance at the 2-year follow-up after pump implantation as an indicator of treatment efficacy, as appreciated by the patients or their caregivers.
Methods:A cohort of 31 patients admitted for ITB therapy was studied. Treatment and follow-up expenses were supported by national health services. Compliance to follow-up visits 2 years after implantation was used as an indicator of treatment efficacy.
Results:Twenty-seven patients (mean age: 28.8 ± 19.3 years) were included in the study. At the 2-year post-implantation set point, 20 patients continued to comply with the treatment program. Those 20 patients reported at least moderate improvements in their symptoms, which justified treatment compliance.
Conclusion:At the 2-year follow-up post-implantation set point, nearly 3 of 4 patients (74.1%) continued to comply with the treatment, indicating treatment efficacy.
Keywords: Baclofen, compliance, intrathecal therapy, neuromodulation, spasticity
The use of oral baclofen (B-[4-chlorophenyl]-g-aminobutyric acid) has been established for the treatment of generalized spasticity. The oral form of the drug has shown clinical benefits for some patients;[
The outcomes from this type of therapy are often assessed by a set of muscle spasticity clinical scales such as the Ashworth scale.[
A cohort of 31 consecutive patients with refractory spasticity managed in our center between 2005 and 2012 were included in the study. Our patients were admitted for an ITB therapy trial. The trial included intrathecal administration of baclofen using a lumbar puncture. A total of 27 patients benefited from the trial and underwent surgical implantation of the battery-based programmable ITB pump (SynchroMed II; Medtronic, Inc., Minneapolis, MN, USA) by the senior author (AA), who followed a standard operative and postoperative protocol. All patients were subsequently referred to a specialized outpatient clinic for medication refilling and to adjust infusion doses. Surgery, implants, medications, and follow-up visits were supported by national health services. All expenses were covered (e.g., surgery, medication, etc.), including transportation. All patients’ data, including their diagnoses, baclofen doses, responses to therapy, follow-up period, and intra and postoperative complications, were collected prospectively; these data were then reviewed and assessed at the time of the study. Programmable ITB pump efficacy was determined based on each patient's compliance at the 2-year follow-up visit following pump device implantation; this served as an indicator of functional efficacy or satisfaction by the patients themselves or their caregivers.
Of the 31 enrolled patients, 4 patients were excluded from the study. The reasons included minimal objective improvement (n = 2) or patient/caregiver dissatisfaction with the baclofen trial (n = 2).
A total of 27 patients (15 males and 12 females) underwent ITB pump insertion. The patients’ ages ranged from 7–70 years (mean: 28.8 ± 19.3 years).
The documented etiologies of spasticity included cerebral palsy in 8 patients (29.6%), traumatic spinal cord injury in 5 patients (18.5%), familial spasticity syndrome in 5 patients (18.5%), inherited spasticity syndromes (e.g., Pelizaeus–Merzbacher disease, pantothenate kinase-associated neurodegeneration, mitochondrial diseases, etc.) in 4 patients (14.8%), myelopathic spondylosis in 2 patients (7.4%), demyelinating disease in 2 patients (7.4%), and spinal cavernoma in 1 patient (3.7%).
In a questionnaire-based survey, 22 patients reported good functional improvement, whereas 5 patients reported moderate improvement, as indicated by the patients themselves or by their caregivers. Baclofen doses ranged from 60–800 μg/day (mean: 253.4 ± 149.5 μg/day). No intraoperative complications were encountered in our cohort. Recurrent infection at the implantation site occurred in one patient, mandating hardware removal.
At the 2-year post-implantation set point, 20 patients (74.1%) continued to comply with the treatment. Treatment failure was defined as refill discontinuation or hardware removal, which occurred in 7 patients (25.9%). This was the result of a patient or caregiver's request indicating unsatisfactory functional improvement (n = 5), infection at the implantation site (n = 1), and death related to recurrent pneumonia (n = 1).
In 1984, Penn and Kroin[
A variety of objective clinical scoring systems has been reported in the literature, including the spasm score, expanded disability status scale (EDSS), ambulation index (AI), incapacity status scale (ISS), health-related quality of life by the sickness impact profile (SIP), and Hopkins symptom checklist (HSCL);[
Such objective clinical scales may not take into consideration the functional improvements noted in this heterogeneous group of patients because the disappearance of muscle spasticity may not necessarily represent functional improvement.[
In our cohort, compliance at 2 years following implantation of the pump device was used as an indicator of treatment efficacy. Given that the treatment plan requires frequent follow-up visits for pump refilling, adjustment, and maintenance, compliance is a strong indication of appreciated functional improvement, as noted by the patients themselves or by their caregivers. Two years after ITB pump implantation, 74.1% of the patients reported at least moderate improvements in their symptoms, meriting compliance with therapy. In this cohort group, all expenses were covered by the national health services. As such, compliance may truly reflect the functional benefit observed in these patients.
Treatment discontinuation occurred in 7 patients (25.9%). Five patients had stopped therapy as per the patient or caregiver's request, as related to treatment dissatisfaction, even in the presence of at least a moderate improvement response among all 7 patients.
ITB pump implantation is generally a safe and well-tolerated procedure. Complications such as mild sedation, dizziness, blurring of vision, seizures, drug overdose, respiratory depression, hypotension, bradycardia, coma, hallucination, hyperthermia, and hardware malfunction have been reported in the literature.[
ITB therapy using battery-based programmable pumps is a relatively safe and effective treatment modality for refractory spasticity. At the 2-year follow-up post-implantation set point, nearly 3 of 4 patients (74.1%) continued to comply with treatment, which is ultimately an indicator of treatment efficacy.
The authors declare no conflicts of interest regarding the production of this article. The authors have no personal financial or institutional interest in any of the drugs, materials, or devices described in this article.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
English-language editing of this manuscript was provided by Journal Prep.
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