Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Subjects' PINS spinal cord stimulator randomized to this arm is on always |
Device: PINS Spinal Cord Stimulator
Subjects will be implanted with PINS spinal cord stimulator
|
| Sham Comparator: Control Subjects' PINS spinal cord stimulator randomized to this arm is off for a week |
Device: PINS Spinal Cord Stimulator
Subjects will be implanted with PINS spinal cord stimulator
|
Outcome Measures
Primary Outcome Measures
- The difference of Visual-analogue scale (VAS) between the experimental group and the control group [13 weeks]
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.
Secondary Outcome Measures
- Changes in VAS [4、12、24 weeks]
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.
- Sleep Quality [4、12、24 weeks]
Quality of sleep will be assessed according to the number of nights with awakenings.
- Changes in Beck Depression Inventory [4、12、24 weeks]
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.
- Change in quality of life as measured by SF-36 [4、12、24 weeks]
The quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) questionnaire.
- Number of subjects with adverse events [24 weeks]
The number of adverse events will be record at each visit.
Eligibility Criteria
Criteria
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
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Be 18 years of age or older at the time of enrollment
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Be willing and able to comply with study-related requirements, procedures, and visits
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Be willing and capable of giving informed consent
Exclusion Criteria:
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Pregnancy or potential for with unwillingness to use contraception
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Have a current diagnosis of a coagulation disorder, bleeding diathesis
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Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control
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Have a life expectancy of less than 1 year
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Have a condition currently requiring or likely to require the use of diathermy
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Other inappropriate situations determined by the researcher
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | China |
Sponsors and Collaborators
- Beijing Pins Medical Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PINS-030