An interventional study of Precise management in Pain, Chronic and Pain, Intractable, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Treatment
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:
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:
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
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.
Time frame: Baseline and Month 1
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 6
Plan to share: No
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