Intrathecal Baclofen Long-Term Follow-Up — Spinal Cord 2004
This 2004 Spinal Cord study provided the first substantial long-term follow-up evidence that intrathecal baclofen maintains its effectiveness over years — not just weeks. Forty patients who had undergone ITB pump implantation at two French university hospital centers were followed for an average of four years and assessed at a final clinical examination in 2001. The study documented sustained efficacy, high patient satisfaction, and a complication profile that clinicians and patients need to understand before committing to pump implantation.
What they did
Researchers at the Departments of Physical Medicine and Rehabilitation and Neurosurgery at CHU Angers and CHU Nantes in western France retrospectively reviewed the medical records of 40 consecutive patients who had undergone ITB pump placement for severe chronic spasticity. Patients were eligible regardless of the origin of their spasticity — 33 had spinal cord origin spasticity (spinal cord injury, multiple sclerosis) and 8 had brain damage origin (stroke, traumatic brain injury, or other cortical causes).
All patients underwent a final assessment in 2001 combining clinical examination and a structured questionnaire. Outcomes measured included Ashworth scale spasticity scores, patient satisfaction on a 10-point visual analog scale (VAS), functional independence (classified as bed-ridden, wheelchair-dependent, or ambulant), and a detailed inventory of technical incidents and pharmacological complications.
The study design is a retrospective case series with a prospective final assessment — not a randomized trial. This means the findings describe what happened to a consecutive sample of real patients over real follow-up periods, rather than controlled conditions. This limits causal inference but provides valuable real-world data on long-term ITB management that controlled short-term trials cannot supply.
What they found
The average follow-up period was four years. The mean Ashworth spasticity score at final assessment was 1.8 ± 0.6 — a low score indicating well-controlled spasticity. Average patient satisfaction was 7.4 out of 10 on the visual analog scale, and 85% of patients said they would choose to undergo the procedure again if they had to make the decision from scratch.
Functional independence was largely preserved: in 85% of cases, ambulatory status was unchanged from before pump implantation. This is a meaningful finding — ITB did not worsen mobility or functional independence for the vast majority of patients across a four-year follow-up.
However, technical incidents were common. At least one technical incident occurred in 37% of patients over the follow-up period. The breakdown by type was: catheter disconnections (4 patients), catheter migration (4), catheter kinks (3), catheter obstruction (3), fibrosis development (3), pump reservoir disconnection (2), pump membrane porosity (2), unexplained pump dysfunction (4), leakage, and subcutaneous collection (5). Catheter problems accounted for 58% of incidents; pump problems for 42%.
Severe pharmacological side effects requiring transfer to intensive care occurred in 12% of cases. Critically, 80% of those severe events were directly related to pump refill procedures — not to the hardware itself. This highlights that routine maintenance procedures carry non-trivial risk and require trained clinical teams.
Why it matters
Before this study, most evidence on intrathecal baclofen came from shorter trials measured in weeks or a few months. The question of whether ITB remained effective over years — and whether patients continued to benefit, or whether tolerance developed and efficacy faded — was not well answered. This study provided the first clear evidence that ITB does sustain its efficacy at the four-year mark, with patient satisfaction remaining high and spasticity well controlled on average.
If you are considering an ITB pump — or helping someone you care about think through that decision — this study is essential reading for what the long-term reality looks like. The 87.5% rate of sustained spasticity control and the 85% patient preference to repeat the procedure are genuinely reassuring numbers. At the same time, the 37% rate of technical incidents over four years is a real figure that should not be minimized. Pump management is not passive: it requires an ongoing relationship with a specialist center capable of diagnosing and managing hardware and pharmacological complications.
The baclofen withdrawal emergency deserves particular attention. If the pump fails and delivery stops suddenly, the resulting withdrawal syndrome — hyperthermia, dramatically increased spasticity, rhabdomyolysis, and potential multi-organ failure — can be life-threatening. This is documented both in this study and in the broader ITB literature. It means that living with a pump requires reliable access to emergency care and that patients and families need to know the warning signs.
Relevance to PLS
The 40-patient cohort included both spinal and cortical origin spasticity — with 8 patients in the brain damage group who would be comparable in mechanism to PLS patients. The study does not report outcomes separately by origin in ways that allow precise extraction of PLS-equivalent data. For PLS-specific ITB outcomes, the ITB Utility in PLS short communication provides more direct evidence. The 2004 Spinal Cord study is best understood as establishing the long-term feasibility and complication profile of ITB across the broader severe-spasticity population that PLS patients join when oral agents fail.
How this connects
This study is a core reference in the Spasticity Research hub. It pairs directly with the 2010 comparative analysis of spinal versus cortical origin spasticity, which examines whether origin of spasticity affects ITB dosing and outcomes — directly relevant to PLS patients, whose spasticity is cortical in origin. The practical aspects of deciding whether to pursue an ITB pump are addressed in the Spasticity management guide.
Citation
Plassat R, Perrouin Verbe B, Menei P, Menegalli D, Mathé JF, Richard I. Treatment of spasticity with intrathecal Baclofen administration: long-term follow-up, review of 40 patients. Spinal Cord. 2004;42(12):686–693. doi:10.1038/sj.sc.3101647.