APP-based Precise Management System of Chronic Intractable Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Precise management
Other interventionThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Precise managementExperimental treatment 1 intervention
Group B: Conventional managementNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 12
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 33
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 6Secondary outcomes
1
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 12
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 33
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 64
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 1Sponsors and contacts
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Source ClinicalTrials.gov