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.