Pain, Chronic Clinical Trial
— PreMaSyOfficial title:
Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 25, 2026 |
Est. primary completion date | September 25, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tsinghua Chang Gung Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tsinghua Chang Gung Hospital |
China,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 1 | Pain intensity is assessed by VAS and compared with baseline VAS score. VAS has a minimum of 0 and a maximum of 10. Higher values mean a stronger pain. | Baseline and Month 1 | |
Secondary | Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 3 | Pain intensity is assessed by VAS and compared with baseline VAS score. VAS has a minimum of 0 and a maximum of 10. Higher values mean a stronger pain. | Baseline and Month 3 | |
Secondary | Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 6 | Pain intensity is assessed by VAS and compared with baseline VAS score. VAS has a minimum of 0 and a maximum of 10. Higher values mean a stronger pain. | Baseline and Month 6 | |
Secondary | Pain Time: Change From Baseline in Time-Intensity Curve at Month 1 | Temporal characteristics of pain is assessed by a time-intensity curve and compared with baseline curve. | Baseline and Month 1 | |
Secondary | Pain Time: Change From Baseline in Time-Intensity Curve at Month 3 | Temporal characteristics of pain is assessed by a time-intensity curve and compared with baseline curve. | Baseline and Month 3 | |
Secondary | Pain Time: Change From Baseline in Time-Intensity Curve at Month 6 | Temporal characteristics of pain is assessed by a time-intensity curve and compared with baseline curve. | Baseline and Month 6 | |
Secondary | Pain Location: Change From Baseline in Pain Map at Month 1 | Spatial characteristics of pain is assessed by a pain map and compared with baseline pain map. | Baseline and Month 1 | |
Secondary | Pain Location: Change From Baseline in Pain Map at Month 3 | Spatial characteristics of pain is assessed by a pain map and compared with baseline pain map. | Baseline and Month 3 | |
Secondary | Pain Location: Change From Baseline in Pain Map at Month 6 | Spatial characteristics of pain is assessed by a pain map and compared with baseline pain map. | Baseline and Month 6 | |
Secondary | Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 1 | Overall health condition is assessed by EQ VAS and compared with baseline EQ VAS. EQ VAS has a minimum of 0 and a maximum of 100. Higher scores mean a better health condition. | Baseline and Month 1 | |
Secondary | Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 3 | Overall health condition is assessed by EQ VAS and compared with baseline EQ VAS. EQ VAS has a minimum of 0 and a maximum of 100. Higher scores mean a better health condition. | Baseline and Month 3 | |
Secondary | Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 6 | Overall health condition is assessed by EQ VAS and compared with baseline EQ VAS. EQ VAS has a minimum of 0 and a maximum of 100. Higher scores mean a better health condition. | Baseline and Month 6 | |
Secondary | Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 1 | Sleep quality is assessed by PSQI and compared with baseline PSQI score. PSQI score has a minimum of 0 and maximum of 21. Higher scores mean a worse sleep quality. | Baseline and Month 1 | |
Secondary | Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 3 | Sleep quality is assessed by PSQI and compared with baseline PSQI score. PSQI score has a minimum of 0 and maximum of 21. Higher scores mean a worse sleep quality. | Baseline and Month 3 | |
Secondary | Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 6 | Sleep quality is assessed by PSQI and compared with baseline PSQI score. PSQI score has a minimum of 0 and maximum of 21. Higher scores mean a worse sleep quality. | Baseline and Month 6 | |
Secondary | Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 1 | The change of overall health condition is assessed by PGIC and compared with baseline PGIC score. PGIC score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition. | Baseline and Month 1 | |
Secondary | Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 3 | The change of overall health condition is assessed by PGIC and compared with baseline PGIC score. PGIC score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition. | Baseline and Month 3 | |
Secondary | Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 6 | The change of overall health condition is assessed by PGIC and compared with baseline PGIC score. PGIC score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition. | Baseline and Month 6 | |
Secondary | Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 1 | The change of overall health condition is assessed by physicians using the CGI-I and compared with baseline CGI-I score. CGI-I score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition. | Baseline and Month 1 | |
Secondary | Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 3 | The change of overall health condition is assessed by physicians using the CGI-I and compared with baseline CGI-I score. CGI-I score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition. | Baseline and Month 3 | |
Secondary | Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 6 | The change of overall health condition is assessed by physicians using the CGI-I and compared with baseline CGI-I score. CGI-I score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition. | Baseline and Month 6 |
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