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High Frequency (1000Hz) Spinal Cord Stimulation in Neuropathic Pain Patients With Virgin Back

NCT03818074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-05

No results posted yet for this study

Summary

Spinal Cord stimulation (SCS) is a common intervention used in patients who suffer from chronic nerve pain following back surgery. This is known as failed back surgery syndrome (FBSS). Equally, the National Institute of Clinical Excellence (NICE) who work with the NHS, recommend suitable medicines and treatments for patients in their guidelines; suggest that SCS can be used in patients who have never had back surgery. The is no outcome data to define that SCS works in patients with neuropathic back pain, therefore this study will provide clinical data to see if this works.

SCS delivers mild electrical impulses to the nerves along the spinal cord. This blocks the pain pathway from reaching the brain. This helps manage the pain experienced the lower back.

A common side effect of the conventional system is that patients may experience 'pins and needles', tingling, and numbness, known as parathesia at site of stimulation. This can be particularly uncomfortable for patients. However, parathesia can be eliminated by changing certain settings on the stimulator. This could include increasing the frequency of the stimulator known as high frequency (HF). This works by delivering energy to site of stimulation below the parathesia threshold, so minimal or no parathesia is experienced.

Only one study has been completed previously using HF frequency on patients with FBSS. The major findings from these studies have found that when compared to conventional SCS (uses a frequency of 40-80 Hz) that HF has provided better pain relief with minimal or no parathesia. Higher frequencies parameters are not completely novel because they have been used in patients who have FBSS. However, settings of 1000Hz which will be used in this study have not been done in patients who suffer from neuropathic pain and have not had any previous spinal surgery.

Therefore, the main reason of this study is to investigate the response patients suffering from neuropathic pain and have not had previous spinal surgery, have to 1000Hz (HF) frequency spinal cord stimulation. We will also investigate the effect this setting has on the quality of life of the patients.

Conditions

  • Neuropathic Pain
  • Low Back Pain

Interventions

DEVICE

Boston Wavewriter 1000Hz Spinal cord Stimulation

High frequency spinal cord stimulation.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Kavita Poply, Dr · Barts & The London NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-09
Primary Completion
2024-07-07
Completion
2024-07-07
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818074 on ClinicalTrials.gov