Status:
UNKNOWN
Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Conditions:
Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 stimula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03858790
Start Date
February 1 2019
End Date
June 1 2020
Last Update
March 1 2019
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, China