Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a remote programming platform: study protocol for a randomized controlled trial (PreMaSy study)

Trials

Study Protocol

Duo Xie¹  Yan Han²  Kaiyuan Yang³  Huifang Zhang³  Weiwei Wu³  Guihuai Wang³  Weitao Man³  Dan Lei³  Linkai Jing³  Dongkang Liu³  Guoqin Wang³  Zhenxing Sun³  Zhe Meng³  Yang Lu⁴  Siying Guo⁵  Yuanchen Cheng⁵ 

[1] Air Force Medical Center PLA, Beijing, China;Department of Neurology Xuanwu Hospital, Capital Medical University, Beijing, China;Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China;Department of Neurosurgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China;Institute for Precision Medicine, Tsinghua University, Beijing, China;School of Medicine, Tsinghua University, Beijing, China;

关键词: Chronic intractable pain;    Spinal cord stimulation;    Remote programming;    Mobile health;    Randomized controlled trial;    Precision medicine;   

DOI  :  10.1186/s13063-023-07595-4

 received in 2023-04-12, accepted in 2023-08-18,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSpinal cord stimulation (SCS) is a surgical technique used in patients with chronic intractable pain, and its effectiveness and safety have been validated by multiple studies. However, to maintain an optimal and steady long-term effect is still challenging. Here, we report a new management paradigm integrating smartphone application and remote programming. Chronic pain patients with SCS implants can monitor their pain status on the phone and change stimulation parameters accordingly. The PreMaSy study is a randomized controlled trial to evaluate the clinical effectiveness and safety of this precise management system.MethodsPatients with chronic intractable pain will be screened for eligibility, and 82 participants are anticipated to be enrolled in this trial. After the electrode implantation, the stimulation effectiveness will be tested. Participants with a reduction of more than 50% in the visual analog scale (VAS) will receive implantation of an implantable pulse generator and randomized (1:1) into the experimental group or control group. All participants will be asked to take online follow-ups and complete assessments using a smartphone application. Daily pain characteristic assessments and monthly quality of life questionnaires are integrated into the App, and participants will be required to complete these assessments. The daily VAS for pain intensity will be monitored and a threshold will be set based on baseline VAS score. The interventional appointment will be scheduled once the threshold is reached. The primary outcome is the health condition and quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). Utility values of EQ-5D-5L will be assessed at baseline and 1, 3, and 6 months post-operative.DiscussionThe PreMaSy study aims to evaluate the effectiveness and safety of a novel App-based, patient-centered, self-assessment management system for chronic intractable pain. A randomized controlled trial is designed to test the non-inferiority of this precise management system compared to the monthly online follow-ups. It is also expected to yield valuable experiences regarding precision medicine.Trial registrationClinicalTrials.gov NCT05761392. Registered on March 07, 2023.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

13690_2023_1170_Article_IEq3.gif

42004_2023_995_Article_IEq44.gif

Fig. 5

Fig. 3

Fig. 4

Fig. 1

13063_2023_7595_Article_IEq4.gif

12862_2023_2164_Article_IEq4.gif

Fig. 5

Fig. 2

12888_2023_5172_Article_IEq11.gif

13690_2023_1170_Article_IEq211.gif