Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.

Detailed Description
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Adult patients with chronic intractable pain of the trunk and/or limbs who are candidates for a treatment with spinal cord stimulation will be prospectively randomized into 2 arms. Spinal cord stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Official Title
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Spinal Cord Stimulation System in the Treatment of Chronic Pain

Conditions
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Pain, Chronic Pain, Back Pain, Spinal Cord Stimulation, Nervous System Diseases

Intervention / Treatment
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* Device: PINS Spinal Cord Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed with chronic, intractable pain of the trunk and/or limbs which has been refractory to conservative therapy for a minimum of 3 months. VAS ≥ 5 Be 18 years of age or older at the time of enrollment Be willing and able to comply with study-related requirements, procedures, and visits Be willing and capable of giving informed consent Exclusion Criteria: Pregnancy or potential for with unwillingness to use contraception Have a current diagnosis of a coagulation disorder, bleeding diathesis Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control Have a life expectancy of less than 1 year Have a condition currently requiring or likely to require the use of diathermy Other inappropriate situations determined by the researcher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Subjects' PINS spinal cord stimulator randomized to this arm is on always | Device: PINS Spinal Cord Stimulator<br>* Subjects will be implanted with PINS spinal cord stimulator<br>|
| Sham Comparator: Control<br>Subjects' PINS spinal cord stimulator randomized to this arm is off for a week | Device: PINS Spinal Cord Stimulator<br>* Subjects will be implanted with PINS spinal cord stimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of Visual-analogue scale (VAS) between the experimental group and the control group | Pain will be evaluated in the different groups according to the Visual-analogue scale (VAS) varying from 0 to 10 with a higher score indicating a higher level of pain. | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in VAS | Pain will be evaluated in the different groups according to the Visual-analogue scale (VAS) varying from 0 to 10 with a higher score indicating a higher level of pain. | 4、12、24 weeks | 
| Sleep Quality | Quality of sleep will be assessed according to the number of nights with awakenings. | 4、12、24 weeks | 
| Changes in Beck Depression Inventory | This will be assessed using the Beck Depression Inventory, a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression. Higher values represent greater severity of depression. | 4、12、24 weeks | 
| Change in quality of life as measured by SF-36 | The quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) questionnaire. | 4、12、24 weeks | 
| Number of subjects with adverse events | The number of adverse events will be record at each visit. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain