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

Not Applicable

• Conditions: Chronic Pain; Back Pain; Spinal Cord Stimulation; Nervous System Diseases; Pain
• Interventions: Device: PINS Spinal Cord Stimulator

• Registration Number: NCT03858790
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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 Timeline

• Status Verified: 2019-02
• Study Start: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Study First Posted: 2019-03-01
• Last Update Posted: 2019-03-01
• Primary Completion: 2020-03
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	PINS Spinal Cord Stimulator	Subjects' PINS spinal cord stimulator randomized to this arm is on always
Control	PINS Spinal Cord Stimulator	Subjects' PINS spinal cord stimulator randomized to this arm is off for a week

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
Number of subjects with adverse events	24 weeks	The number of adverse events will be record at each visit.

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China