What are the indications for intrathecal (directly into the spinal canal) baclofen (a muscle relaxant) therapy using a pump?

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Indications for Intrathecal Baclofen Therapy/Pump

Intrathecal baclofen therapy is indicated primarily for severe spastic hypertonia that does not respond to other interventions, including oral antispasticity medications, botulinum toxin injections, and physical modalities. 1

Primary Indications

Spasticity of Spinal Origin

  • Multiple sclerosis with severe spasticity
  • Spinal cord injury with disabling spasticity
  • Spinal cord diseases with significant spasticity

Refractory Spasticity

  • Patients who have failed oral baclofen therapy
  • Patients who experience intolerable side effects from oral medications
  • Patients with severe spasticity requiring higher doses than can be tolerated orally

Post-Stroke Spasticity

  • Can be considered as early as 3-6 months after stroke for patients with severe spastic hypertonia refractory to other treatments 1
  • Note: While the FDA label does not specifically indicate baclofen for stroke 2, clinical guidelines support its use in severe post-stroke spasticity 1

Clinical Decision Algorithm

  1. First-line treatments (try these before considering ITB):

    • Positioning, passive stretching, and range of motion exercises
    • Oral antispasticity medications (tizanidine, oral baclofen, dantrolene)
    • Targeted botulinum toxin injections for focal spasticity
    • Physical modalities (NMES, vibration)
  2. Consider ITB when:

    • Spasticity is severe and generalized
    • Patient has failed or cannot tolerate maximum doses of oral medications
    • Spasticity causes significant functional limitations:
      • Pain
      • Poor skin hygiene
      • Decreased function
      • Interference with positioning
      • Increased caregiver burden
      • Reduced quality of life
  3. Trial before implantation:

    • A test dose of intrathecal baclofen should be administered
    • Proceed with pump implantation only if satisfactory response is observed

Expected Benefits

  • Reduction in Ashworth scores for muscle rigidity 3
  • Decrease in spasm frequency and severity 3
  • Improved range of motion
  • Decreased pain
  • Improved sleep quality
  • Enhanced ability to perform activities of daily living
  • Improved bowel and bladder program performance 4
  • Reduced caregiver burden

Important Considerations and Cautions

Withdrawal Risk

  • Abrupt cessation of intrathecal baclofen can lead to catastrophic withdrawal syndrome 1
  • Withdrawal can evolve over 1-3 days and may become fulminant if not recognized
  • Symptoms include increased spasticity, fever, altered mental status, seizures
  • Emergency treatment includes resuming intrathecal infusion or high-dose benzodiazepine IV infusion

Complications

  • Catheter-related issues (occlusion, breaks, dislodgment)
  • Pump malfunction
  • Infection (pocket infection, meningitis)
  • Drug-related side effects (hypotonia, urinary retention, drowsiness)
  • Development of tolerance

Concentration Considerations

  • Concentration of baclofen in the pump may affect spasticity control 5
  • Higher concentrations may be considered during pandemics or other situations to reduce refill frequency 1

Follow-up Requirements

  • Regular pump refills (timing depends on dose and concentration)
  • Periodic assessment of efficacy and dose adjustments
  • Monitoring for complications or side effects
  • Patient education regarding signs of withdrawal or overdose

Intrathecal baclofen therapy represents an advanced intervention for severe spasticity that should be considered when conventional treatments fail to provide adequate relief. The therapy has demonstrated significant improvements in quality of life, function, and caregiver burden for appropriately selected patients.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Functional outcome after delivery of intrathecal baclofen.

Archives of physical medicine and rehabilitation, 1989

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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