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A Study to Investigate High-density Spinal Cord Stimulation in Virgin-back Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716973
Recruitment Status : Active, not recruiting
First Posted : October 23, 2018
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief Summary:

This study will look into the effectiveness of spinal cord stimulation (SCS) in reducing chronic neuropathic pain in patients who have not had previous spinal surgery. This will be assessed by comparing the Numerical Rating Scale (NRS) questionnaire responses before and after the SCS intervention.

We will also investigate the effect of HD frequency parameters on the improvement of quality of life, sleep and any adverse events following the spinal cord stimulation.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: High Density Programming Not Applicable

Detailed Description:

Traditionally, spinal cord stimulation (SCS) has been used for patients with chronic neuropathic pain following back surgery (a condition known as Failed Back Surgery Syndrome (FBSS)). Although the National Institute for Health and Care Excellence (NICE) also recommends SCS for chronic neuropathic pain without previous back surgery, clinical outcome data is much needed in this patient group. Conventionally, patients receiving SCS are provided with tonic stimulation settings (where they feel tingling and paraesthesia); however newer methods include high-density stimulation (HD) that provides higher energy allowing the voltage to be reduced to subthreshold parameters, hence minimizing the tingling and paraesthesia. HD stimulation is widely offered to patients with SCS as part of routine clinical practice, although no known studies have yet investigated HD settings in patients with neuropathic pain without previous spinal surgery. Therefore, the purpose of this study is to determine the effectiveness of HD settings in patients without previous spinal surgery undergoing SCS. 20 patients without previous spinal surgery who are deemed suitable for SCS as part of NICE guidelines 159 pathway will be recruited for the study.

All patients have a trial of SCS where they will be offered HD settings. If successful (>50% improvement in pain scores) they will be offered permanent implant. Those patients whose pain does not improve with HD settings will be further offered conventional tonic stimulation for one more week. Those patients who do not respond to both tonic and HD settings will be excluded and will not have permanent implant. This will also allow us to investigate the patient's preference between the HD neurostimulator settings and conventional tonic settings. We will also investigate the response to these stimulator settings on health related quality of life. Patients will complete quality of life questionnaires at Baseline, 1-month, 3-months and 12-months post-implant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study to Investigate the Response to High Density Stimulation With Medtronic Restore Sensor Technology in Patients With Intractable Neuropathic Pain Who Have Not Had Spinal Surgery
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: High density programming
High density programming of spinal cord stimulator for paraesthesia-free therapy.
Device: High Density Programming
Patients implanted with Medtronic spinal cord stimulator will have high density programming.




Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) [ Time Frame: Baseline, 1-month, 3-months, 12months ]
    Investigate the change in reported pain scores (NRS) following percutaneous spinal cord stimulation (SCS) with Restore Sensor in patients with lumbar radiculopathy who have not undergone any spinal surgery ("virgin back").


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline, 1-month, 3-months, 12months ]
    low back functional outcome tool

  2. Patient's Global Impression of change (PGIC) [ Time Frame: Baseline, 1-month, 3-months, 12months ]
    A standard seven point scale would be used to assess the SCS outcome.

  3. Pain and Sleep Questionnaire _3 (PSQ_3) [ Time Frame: Baseline, 1-month, 3-months, 12months ]
    A three-item index for the assessment of the impact of pain on sleep.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Male and female patients between 18-75 years of age who have lumbar radiculopathy who have not undergone any spinal surgery.
  • Patients with intractable neuropathic pain due to undergo Percutaneous Spinal Cord Stimulation as part of their standard treatment for lumbar neuropathic pain as per NICE HTA guidance 159 at Barts Health NHS Hospitals. The decision would be made by the multidisciplinary team by reviewing the history, MRI scans and patient choice.
  • Patients who have given their written informed consent.
  • Female patients of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test.

Exclusion Criteria:

  • Patients with diabetes or any underlying neurological condition.
  • Patients known to have a condition that in the investigator's judgement precludes participation in the study.
  • Patients who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
  • Patients unable to comply with the study assessments and to complete the questionnaires.

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): NCT03716973


Locations
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United Kingdom
Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Barts & The London NHS Trust
Medtronic
Investigators
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Principal Investigator: Vivek Mehta, MD Barts & The London NHS Trust

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03716973    
Other Study ID Numbers: 011454
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Barts & The London NHS Trust:
spinal cord stimulation
paraesthesia-free
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms