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Spinal Cord Stimulation Frequency Study

Primary Purpose

Failed Back Surgery Syndrome

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Sham

1200 Hz

3030 Hz

5882 Hz

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Guy's and St. Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Arm Label

Sham

1200 Hz

3030 Hz

5882 Hz

Arm Description

Frequency Setting - Sham

Frequency Setting - 1200 Hz

Frequency Setting - 3030 Hz

Frequency Setting - 5882 Hz

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) on Back Pain

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01750229

First Posted

November 19, 2012

Last Updated

May 23, 2017

Sponsor

MedtronicNeuro

1. Study Identification

Unique Protocol Identification Number

NCT01750229

Brief Title

Spinal Cord Stimulation Frequency Study

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedtronicNeuro

4. Oversight

5. Study Description

Brief Summary

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).

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Failed Back Surgery Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Frequency Setting - Sham

Arm Title

1200 Hz

Arm Type

Experimental

Arm Description

Frequency Setting - 1200 Hz

Arm Title

3030 Hz

Arm Type

Experimental

Arm Description

Frequency Setting - 3030 Hz

Arm Title

5882 Hz

Arm Type

Experimental

Arm Description

Frequency Setting - 5882 Hz

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

Frequency Setting - Sham

Intervention Type

Device

Intervention Name(s)

1200 Hz

Intervention Description

Frequency Setting - 1200 Hz

Intervention Type

Device

Intervention Name(s)

3030 Hz

Intervention Description

Frequency Setting - 3030 Hz

Intervention Type

Device

Intervention Name(s)

5882 Hz

Intervention Description

Frequency Setting - 5882 Hz

Primary Outcome Measure Information:

Title

Visual Analog Scale (VAS) on Back Pain

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adnan Al-Kaisy, Dr.

Organizational Affiliation

Guy's and St Thomas' NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guy's and St. Thomas' NHS Foundation Trust

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34854473

Citation

O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Results Reference

derived

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Spinal Cord Stimulation Frequency Study

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