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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858790
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Chronic Pain Back Pain Spinal Cord Stimulation Nervous System Diseases Device: PINS Spinal Cord Stimulator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Subjects' PINS spinal cord stimulator randomized to this arm is on always
 Device: PINS Spinal Cord Stimulator
Subjects will be implanted with PINS spinal cord stimulator
Sham Comparator: Control
Subjects' PINS spinal cord stimulator randomized to this arm is off for a week
 Device: PINS Spinal Cord Stimulator
Subjects will be implanted with PINS spinal cord stimulator


Outcome Measures
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Primary Outcome Measures :
  1. The difference of Visual-analogue scale (VAS) between the experimental group and the control group [ Time Frame: 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 :
  1. Changes in VAS [ Time Frame: 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.

  2. Sleep Quality [ Time Frame: 4、12、24 weeks ]
    Quality of sleep will be assessed according to the number of nights with awakenings.

  3. Changes in Beck Depression Inventory [ Time Frame: 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.

  4. Change in quality of life as measured by SF-36 [ Time Frame: 4、12、24 weeks ]
    The quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36) questionnaire.

  5. Number of subjects with adverse events [ Time Frame: 24 weeks ]
    The number of adverse events will be record at each visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858790


Contacts
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Contact: Fumin Jia, PhD 010-60736388 pins_medical@163.con

Locations
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China
China-Japan Friendship Hospital Recruiting
Beijing, China
Contact: Bifa Fan    010-84205959    fbf1616@yeah.net   
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT03858790    
Other Study ID Numbers: PINS-030
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Pins Medical Co., Ltd:
Pain
Additional relevant MeSH terms:
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Nervous System Diseases
Chronic Pain
Pain
Neurologic Manifestations