Clinical trial NCT05761392: APP-based Precise Management System of Chronic Intractable Pain
Official title: Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Pain, Intractable
Keywords: Pain management
Spinal cord stimulation
Remote programming
Mobile health
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After taking the stimulator implantation surgery, participants in the interventional group are asked to take conventional follow-up including 1-, 3-, 6-month post-operative. Other than that, participants will be asked to take additional self-assessments, including daily pain state and monthly health conditions.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Chronic intractable pain is a disorder with complicated causes. The patient's quality of life is significantly reduced as a result of the patient's ongoing discomfort and the necessity for lengthy therapies. When patients don't respond well to medicine or other non-surgical treatments, spinal cord stimulation (SCS) is one of the surgical methods employed. The safety and effectiveness of SCS have previously been confirmed in numerous trials as a well-researched and clinically used therapy. However, the adjustment of SCS is complicated and its optimal effect relies on long-term regular follow-up. With the development of the internet, the investigators put forward a new system with remote and wireless SCS devices. Together with an exclusively developed mobile phone application, patients will be able to record their daily pain state and monthly health condition and make customized stimulation settings accordingly. This study is aimed to test the feasibility of this new precise management system. All participants will be randomly assigned to either interventional or control group. Participants in control group will be asked to take the conventional follow-up. Participants in interventional group will be additionally asked to take self-assessment on daily pain state and monthly health condition. The investigators hypothesized that this self-involved, closely monitored, and precisely adjusted system can significantly improve patients' quality of life in the long term and cut down both the financial expenses and time cost.

Eligibility criteria: Inclusion Criteria:

* Have been clinically diagnosed with chronic, intractable pain for more than three months.
* At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
* At enrollment, the age is no younger than 18-year-old.
* Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care.
* Voluntary to take the trial and sign the informed consent.
* Good compliance and ability to complete post-operative follow-ups.
* Basic ability to read and use a mobile phone or having a caregiver who can.

Exclusion Criteria:

* Bleeding complications or coagulation disorders.
* Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
* Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
* Systemic active infections or local infections around the surgery area.
* Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
* Metastatic malignant tumors or untreated malignant tumors.
* Life expectancy of less than one year.
* Already provided with a medication pump and/or other implanted devices.
* Need for therapy or examination that must not have an implanted pulse generator (IPG), such as magnetic resonance imaging (MRI) and thermo-therapy.
* Heavily addicted to alcohol or drugs.
* VAS improvement less than 50% or stimulation intolerance during the test period.
* Unable to complete long-term online follow-ups because of hardware issues such as internet, mobile phones, and so on.
* Unwilling to participate.
* Other inappropriate situations determined by the investigators.

Primary outcomes:
measure: Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1
timeFrame: Baseline and Month 1
measure: Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 3
timeFrame: Baseline and Month 3
measure: Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 1
timeFrame: Baseline and Month 1
measure: Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 3
timeFrame: Baseline and Month 3
measure: Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 6
timeFrame: Baseline and Month 6
measure: Pain Time: Change From Baseline in Time-Intensity Curve at Month 1
timeFrame: Baseline and Month 1
measure: Pain Time: Change From Baseline in Time-Intensity Curve at Month 3
timeFrame: Baseline and Month 3
measure: Pain Time: Change From Baseline in Time-Intensity Curve at Month 6
timeFrame: Baseline and Month 6
measure: Pain Location: Change From Baseline in Pain Map at Month 1
timeFrame: Baseline and Month 1
measure: Pain Location: Change From Baseline in Pain Map at Month 3
timeFrame: Baseline and Month 3
measure: Pain Location: Change From Baseline in Pain Map at Month 6
timeFrame: Baseline and Month 6
measure: Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 1
timeFrame: Baseline and Month 1
measure: Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 3
timeFrame: Baseline and Month 3
measure: Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 6
timeFrame: Baseline and Month 6
measure: Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 1
timeFrame: Baseline and Month 1
measure: Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 3
timeFrame: Baseline and Month 3
measure: Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 6
timeFrame: Baseline and Month 6
measure: Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 1
timeFrame: Baseline and Month 1
measure: Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 3
timeFrame: Baseline and Month 3
measure: Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 6
timeFrame: Baseline and Month 6
measure: Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 1
timeFrame: Baseline and Month 1
measure: Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 3
timeFrame: Baseline and Month 3
measure: Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: Yang Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han Y, Lu Y, Wang D, Ran M, Ren Q, Xie D, Aziz TZ, Li L, Wang JJ. The Use of Remote Programming for Spinal Cord Stimulation for Patients With Chronic Pain During the COVID-19 Outbreak in China. Neuromodulation. 2021 Apr;24(3):441-447. doi: 10.1111/ner.13382. Epub 2021 Mar 22.
citation: Lu Y, Xie D, Zhang X, Dong S, Zhang H, Yu B, Wang G, Wang JJ, Li L. Management of Intractable Pain in Patients With Implanted Spinal Cord Stimulation Devices During the COVID-19 Pandemic Using a Remote and Wireless Programming System. Front Neurosci. 2020 Dec 8;14:594696. doi: 10.3389/fnins.2020.594696. eCollection 2020.