Back Pain, Chronic Pain, Nervous System Diseases, Pain, Spinal Cord Stimulation
Conditions
Keywords
Pain
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.
Interventions
DEVICEPINS Spinal Cord Stimulator
Subjects will be implanted with PINS spinal cord stimulator
Sponsors
Beijing Pins Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. VAS ≥ 5 3. Be 18 years of age or older at the time of enrollment 4. Be willing and able to comply with study-related requirements, procedures, and visits 5. Be willing and capable of giving informed consent
Exclusion criteria
1. Pregnancy or potential for with unwillingness to use contraception 2. Have a current diagnosis of a coagulation disorder, bleeding diathesis 3. Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control 4. Have a life expectancy of less than 1 year 5. Have a condition currently requiring or likely to require the use of diathermy 6. Other inappropriate situations determined by the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactFumin Jia, PhD
Outcome results
None listed