Spinal Cord Stimulation System in the Treatment of Chronic Pain
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- The difference of Visual-analogue scale (VAS) between the experimental group and the control group
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Arms & Interventions
Control
Subjects' PINS spinal cord stimulator randomized to this arm is off for a week
Intervention: PINS Spinal Cord Stimulator (Device)
Experimental
Subjects' PINS spinal cord stimulator randomized to this arm is on always
Intervention: PINS Spinal Cord Stimulator (Device)
Outcomes
Primary Outcomes
The difference of Visual-analogue scale (VAS) between the experimental group and the control group
Time Frame: 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 Outcomes
- Changes in VAS(4、12、24 weeks)
- Sleep Quality(4、12、24 weeks)
- Change in quality of life as measured by SF-36(4、12、24 weeks)
- Changes in Beck Depression Inventory(4、12、24 weeks)
- Number of subjects with adverse events(24 weeks)