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

Beijing Pins Medical Co., Ltd54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Chronic Pain Back Pain Spinal Cord Stimulation Nervous System Diseases

Interventions

PINS Spinal Cord StimulatorDEVICE

Subjects will be implanted with PINS spinal cord stimulator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 13 weeks

Secondary Outcomes

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.

Time frame: 4、12、24 weeks

Sleep Quality

Quality of sleep will be assessed according to the number of nights with awakenings.

Time frame: 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.

Time frame: 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.

Time frame: 4、12、24 weeks

Number of subjects with adverse events

The number of adverse events will be record at each visit.

Time frame: 24 weeks

Central Contacts

Fumin Jia, PhD

CONTACT

010-60736388 pins_medical@163.con

Data from ClinicalTrials.gov

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