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

Primary Purpose

Pain, Chronic Pain, Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PINS Spinal Cord Stimulator
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Control

Arm Description

Subjects' PINS spinal cord stimulator randomized to this arm is on always

Subjects' PINS spinal cord stimulator randomized to this arm is off for a week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Sleep Quality
Quality of sleep will be assessed according to the number of nights with awakenings.
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.
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.
Number of subjects with adverse events
The number of adverse events will be record at each visit.

Full Information

First Posted
February 20, 2019
Last Updated
February 27, 2019
Sponsor
Beijing Pins Medical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03858790
Brief Title
Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain
Official Title
Spinal Cord Stimulation System in the Treatment of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Back Pain, Spinal Cord Stimulation, Nervous System Diseases
Keywords
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects' PINS spinal cord stimulator randomized to this arm is on always
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Subjects' PINS spinal cord stimulator randomized to this arm is off for a week
Intervention Type
Device
Intervention Name(s)
PINS Spinal Cord Stimulator
Intervention Description
Subjects will be implanted with PINS spinal cord stimulator
Primary Outcome Measure Information:
Title
The difference of Visual-analogue scale (VAS) between the experimental group and the control group
Description
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 Outcome Measure Information:
Title
Changes in VAS
Description
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
Title
Sleep Quality
Description
Quality of sleep will be assessed according to the number of nights with awakenings.
Time Frame
4、12、24 weeks
Title
Changes in Beck Depression Inventory
Description
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
Title
Change in quality of life as measured by SF-36
Description
The quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) questionnaire.
Time Frame
4、12、24 weeks
Title
Number of subjects with adverse events
Description
The number of adverse events will be record at each visit.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fumin Jia, PhD
Phone
010-60736388
Email
pins_medical@163.con
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bifa Fan
Phone
010-84205959
Email
fbf1616@yeah.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34854473
Citation
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Results Reference
derived
PubMed Identifier
33363453
Citation
Lu Y, Xie D, Zhang X, Dong S, Zhang H, Yu B, Wang G, Wang JJ, Li L. Management of Intractable Pain in Patients With Implanted Spinal Cord Stimulation Devices During the COVID-19 Pandemic Using a Remote and Wireless Programming System. Front Neurosci. 2020 Dec 8;14:594696. doi: 10.3389/fnins.2020.594696. eCollection 2020.
Results Reference
derived
PubMed Identifier
33028415
Citation
Lu Y, Mao P, Wang G, Tao W, Xiong D, Ma K, Li R, Feng D, Duan W, Li S, Fu Z, Feng Z, Jin Y, Wan L, Lu Y, Zhang D, Fan B, Wang JJ, Li L. Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study). Trials. 2020 Oct 7;21(1):834. doi: 10.1186/s13063-020-04768-3.
Results Reference
derived

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

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