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

February 27, 2019 updated by: Beijing Pins Medical Co., Ltd

Spinal Cord Stimulation System in the Treatment of Chronic Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4、12、24 weeks
Sleep Quality
Time Frame: 4、12、24 weeks
Quality of sleep will be assessed according to the number of nights with awakenings.
4、12、24 weeks
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、12、24 weeks
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.
4、12、24 weeks
Number of subjects with adverse events
Time Frame: 24 weeks
The number of adverse events will be record at each visit.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (ACTUAL)

March 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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