NCT05761392: PreMaSy

APP-based Precise Management System of Chronic Intractable Pain

Recruiting now NA Last updated 9 March 2023

What this trial tests

NA trial testing Precise management in Pain, Chronic in 120 participants. Currently enrolling.

Timeline

26 September 2022

Primary endpoint
25 September 2026

25 September 2026

Quick facts

Lead sponsor	Beijing Tsinghua Chang Gung Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	26 September 2022
Primary completion	25 September 2026
Estimated completion	25 September 2026
Sites	1 location across China

Drugs / interventions tested

• Precise management

Conditions studied

• Pain, Chronic — all drugs for Pain, Chronic →
• Pain, Intractable — all drugs for Pain, Intractable →

Sponsor

Beijing Tsinghua Chang Gung Hospital

Who can join

18 and older, any sex, with Pain, Chronic or Pain, Intractable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well. The main questions it aims to answer are:

* Is it better to improve the patient's quality of life than the current conventional follow-up?
* Is it better to relieve pain in the long term than the current conventional follow-up?
* Is it possible to be applied to a large population of chronic pain patients? Participants will be randomly assigned to either a control group or an interventional group.

Participants in the control group will be given the standard SCS implantation surgery and asked to complete the conventional follow-up (at least 1-, 3-, and 6-month post-operative).

Participants in the interventional group will be given the standard SCS implantation surgery and asked to do the following things:

* Take the daily pain self-assessment questions on a mobile phone APP.
* Take the monthly healthy status self-assessment questionnaires on a mobile phone APP.
* Take the conventional follow-up (at least 1-, 3-, and 6-month post-operative). Researchers will compare the two groups to see if the life quality of the interventional group is improved.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Cheng Y, Xie D, Han Y, Guo S, et al · · 2023 · cited 1× · PMID 37691092 · DOI 10.1186/s13063-023-07595-4