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

NCT03716973 | Completed

• 1 other identifier: 011454
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

spinal cord stimulation; paraesthesia-free

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  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").

  Baseline, 1-month, 3-months, 12months

Secondary Outcomes (3)

• Oswestry Disability Index (ODI)

  Baseline, 1-month, 3-months, 12months

• Patient's Global Impression of change (PGIC)

  Baseline, 1-month, 3-months, 12months

• Pain and Sleep Questionnaire _3 (PSQ_3)

  Baseline, 1-month, 3-months, 12months

Study Arms (1)

High density programming

EXPERIMENTAL

High density programming of spinal cord stimulator for paraesthesia-free therapy.

Device: High Density Programming

Interventions

High Density Programming DEVICE

Patients implanted with Medtronic spinal cord stimulator will have high density programming.

High density programming

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Medtronic: collaborator

Study Sites (1)

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Mehta, MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label pilot study

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 23, 2018
• Study Start: May 9, 2017
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)