APP-based Precise Management System of Chronic Intractable Pain

NCT05761392 | Recruiting DMC

• 1 other identifier: 20220908
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Pain, Intractable

Keywords

Pain management; Spinal cord stimulation; Remote programming; Mobile health

Outcome Measures

Primary Outcomes (3)

• Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1

  Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.

  Baseline and Month 1

• Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 3

  Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.

  Baseline and Month 3

• Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 6

  Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.

  Baseline and Month 6

Secondary Outcomes (21)

• Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 1

  Baseline and Month 1

• Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 3

  Baseline and Month 3

• Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 6

  Baseline and Month 6

• Pain Time: Change From Baseline in Time-Intensity Curve at Month 1

  Baseline and Month 1

• Pain Time: Change From Baseline in Time-Intensity Curve at Month 3

  Baseline and Month 3

Study Arms (2)

Precise management

EXPERIMENTAL

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.

Other: Precise management

Conventional management

NO INTERVENTION

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.

Interventions

Precise management 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.

Precise management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 33751731 BACKGROUND

• 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.

  PMID: 33363453 BACKGROUND

• 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.

  PMID: 37691092 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pain, Intractable; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Yang Lu, MD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Lu, MD

CONTACT

18600391166; lya02121@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurocenter of Beijing Tsinghua Changgung Hospital

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 9, 2023
• Study Start: September 26, 2022
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)