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APP-based Precise Management System of Chronic Intractable Pain

NCT05761392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-03-09

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Chronic
  • Pain, Intractable

Interventions

OTHER

Precise management

The daily pain state assessments contain three components, the visual analogue scale (VAS) based on pain intensity, time-intensity curve throughout the day, and pain locations. The VAS scores from the first seven post-operative days will be collected as the baseline data. The interventional threshold will be determined by adding 30 mm (if the scale length were 100 mm) to the baseline mean. If participants score above the threshold three times in a row, a warning will be sent to their physicians. A remote meeting will be scheduled and stimulation settings will be adjusted accordingly.

Sponsors & Collaborators

  • Beijing Tsinghua Chang Gung Hospital

    lead OTHER

Principal Investigators

  • Yang Lu, MD · Beijing Tsinghua Chang Gung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2026-09-25
Completion
2026-09-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761392 on ClinicalTrials.gov