Intrathecal Pump Refills at Home or at the Hospital
Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial
Moens Maarten
82 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
Summary
The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable. Eighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.
Eligibility
Inclusion Criteria3
- Actively receiving Intrathecal drug delivery
- Stable medication dosage for at least 3 months
- Dutch, French or English speaking adults
Exclusion Criteria3
- Life expectancy < 6 months
- Patients planned for but not yet received Intrathecal drug delivery implant
- No residence in Belgium
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Intrathecal pump refill procedure conducted at the hospital
Intrathecal pump refill procedure conducted at the home of the patient
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07727798