Spinal Cord Stimulation Frequency Study

Failed Back Surgery Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750229
• Other study ID #: 1668
• Status: Completed
• Phase: N/A
• First received: November 19, 2012
• Last updated: May 23, 2017
• Start date: December 2012
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Device:
• Sham
Frequency Setting - Sham
• 1200 Hz
Frequency Setting - 1200 Hz
• 3030 Hz
Frequency Setting - 3030 Hz
• 5882 Hz
Frequency Setting - 5882 Hz

Locations

Country	Name	City	State
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks