Background: Intrathecal drug delivery using implantable pumps is an effective method to control stable chronic pain. However, the appropriate alleviation of unpredictable pain fluctuations remains challenging. A possible solution is the use of patient-controlled analgesia (PCA) by means of a specific device--the personal therapy manager (PTM)--designed to be used with implanted programmable pumps.
Methods: A multicenter (n = 17), open-label registry recording 168 patients suffering from chronic pain with unsatisfactory control of pain episodes was initiated. While 79 patients (47%) (group A) already carried an implanted pump at enrollment, all other patients were implanted after being registered in the study (group B). Parameters assessed included pain relief (visual analog score, VAS), quality of life (EQ-5D), patient and physician satisfaction, medication use, PTM programming parameters and adverse events. Final follow-up was at 12 months.
Results: At 12 months, there was a significant reduction (29%) of the overall average VAS compared with baseline (P < 0.01) in patients with newly implanted devices (group B). All patients tended to decrease the concomitant pain medication and the quality of life tended to improve (10% on the EQ-5D scale). In total, 85% of patients were satisfied with the PTM. No serious adverse events related to the use of the PTM device were observed.
Conclusions: Patient-controlled analgesia using a PTM with a programmable, implantable pump system is an effective therapy for the treatment of chronic pain and allows patients to feel that they have more control over unpredictable pain fluctuations.