APP-based Precise Management System of Chronic Intractable Pain

NCT ID: NCT05761392

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2026-09-25

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.

Conditions

Pain, Chronic; Pain, Intractable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Precise management

Participants will be asked to take daily pain state and monthly health condition assessments.

A warning for the physicians will be given when participants reach daily assessment threshold. Remote interventional meeting will be scheduled and stimulation parameters will be adjusted accordingly.

Participants will also be asked to take conventional follow-up at 1-, 3-, and 6-month post-operative.

Group Type: EXPERIMENTAL

Precise management

Intervention Type: OTHER

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.

Conventional management

Participants will be only asked to take conventional follow-ups at 1-, 3-, and 6-month post-operative. During these follow-ups, they will be asked to score VAS based on general pain state, and take questionnaires including EQ-5D-5L, PSQI, PGIC, CGI-I.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guihuai Wang

Director of Neurocenter of Beijing Tsinghua Changgung Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Chang Gung Hospital

Locations

Beijing Tsinghua Chang Gung Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Lu, MD

Role: CONTACT

lya02121@btch.edu.cn

18600391166 ext. +86

Facility Contacts

Role: primary

office@btch.edu.cn

010-56112345 ext. +86

References

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.

Reference Type: BACKGROUND

PMID: 33751731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33363453 (View on PubMed)

Cheng Y, Xie D, Han Y, Guo S, Sun Z, Jing L, Man W, Liu D, Yang K, Lei D, Meng Z, Zhang H, Wang G, Wu W, Wang G, Lu Y. 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. 2023 Sep 11;24(1):580. doi: 10.1186/s13063-023-07595-4.

Reference Type: DERIVED

PMID: 37691092 (View on PubMed)

Other Identifiers

20220908

Identifier Type: -

Identifier Source: org_study_id