Spinal Cord Stimulation Frequency Study
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)
1 other identifier
interventional
53
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
December 18, 2017
CompletedDecember 18, 2017
May 1, 2017
3.7 years
November 19, 2012
March 16, 2017
May 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Sham
SHAM COMPARATORFrequency Setting - Sham
1200 Hz
EXPERIMENTALFrequency Setting - 1200 Hz
3030 Hz
EXPERIMENTALFrequency Setting - 3030 Hz
5882 Hz
EXPERIMENTALFrequency Setting - 5882 Hz
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (1)
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
Related Publications (1)
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.
PMID: 34854473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neuro Clinical Trials
- Organization
- Medtronic Neuromodulation
Study Officials
- PRINCIPAL INVESTIGATOR
Adnan Al-Kaisy, Dr.
Guy's and St Thomas' NHS Foundation Trust
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2012
First Posted
December 17, 2012
Study Start
December 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
December 18, 2017
Results First Posted
December 18, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share