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

Pain Clinical Trial

Official title:

Spinal Cord Stimulation System in the Treatment of Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858790
• Other study ID #: PINS-030
• Status: Recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: June 2020

Study information

• Verified date: February 2019
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia, PhD
• Phone: 010-60736388
• Email: pins_medical[@]163.con
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Nervous System Diseases
• Pain
• Spinal Cord Stimulation

Intervention

Device:
• PINS Spinal Cord Stimulator
Subjects will be implanted with PINS spinal cord stimulator

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 weeks
Secondary	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.	4?12?24 weeks
Secondary	Sleep Quality	Quality of sleep will be assessed according to the number of nights with awakenings.	4?12?24 weeks
Secondary	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.	4?12?24 weeks
Secondary	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.	4?12?24 weeks
Secondary	Number of subjects with adverse events	The number of adverse events will be record at each visit.	24 weeks