Spinal Cord Stimulation Frequency Study

May 23, 2017 updated by: MedtronicNeuro

Randomized Controlled Double-blind Cross-over Trial Evaluating the Role of Frequencies on Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome (SCS Frequency Study)

The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 Hz, 3030 Hz, and 5882 Hz.

Study Type

Interventional

Enrollment (Actual)

53

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

  • United Kingdom
      • London, United Kingdom
        • Guy's and St. Thomas' NHS Foundation Trust

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:

  • At least 18 years old at the time of informed consent
  • Willing and able to provide a signed and dated informed consent
  • Capable of comprehending and consenting in English
  • Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
  • On a stable dose (no new, discontinued or changes in) of all prescribed pain medications and willing/able to maintain or only decrease the dose of all prescribed pain medications
  • Tried appropriate conventional medical management for their pain
  • Not indicated for additional surgical treatment in the opinion of the referring physician or spinal surgeon
  • Undergone previous spinal surgery
  • Diagnosed with FBSS with appropriate pain score
  • Primary pain at appropriate spinal level

Exclusion Criteria:

  • Has an active implanted device, whether turned on or off
  • Displays current signs of a systemic infection
  • Pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
  • Has untreated major psychiatric comorbidity
  • Has serious drug-related behavioral issues
  • Has neurological abnormalities unrelated to Failed Back Surgery Syndrome
  • Diagnosed with Raynaud disease
  • Diagnosed with Fibromyalgia
  • Has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
  • Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
  • Participating or planning to participate in another clinical trial
  • Has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Frequency Setting - Sham
Device: Sham
Frequency Setting - Sham
Experimental: 1200 Hz
Frequency Setting - 1200 Hz
Device: 1200 Hz
Frequency Setting - 1200 Hz
Experimental: 3030 Hz
Frequency Setting - 3030 Hz
Device: 3030 Hz
Frequency Setting - 3030 Hz
Experimental: 5882 Hz
Frequency Setting - 5882 Hz
Device: 5882 Hz
Frequency Setting - 5882 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) on Back Pain
Time Frame: 12 weeks
Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.
12 weeks

Collaborators and Investigators

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

Sponsor

MedtronicNeuro

Investigators

  • Principal Investigator: Adnan Al-Kaisy, Dr., Guy's and St Thomas' NHS Foundation Trust

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

December 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Failed Back Surgery Syndrome

Clinical Trials on Sham

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe