Failed Back Surgery SyndromeNCT01750229
Spinal Cord Stimulation Frequency Study
A study testing 1200 Hz, 3030 Hz and 5882 Hz in people with Failed Back Surgery Syndrome, run by MedtronicNeuro at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- 1200 Hz, 3030 Hz and 5882 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this 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)
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).
Read the detailed description
Prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 Hz, 3030 Hz, and 5882 Hz.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Sham, 1200 Hz, 3030 Hz, 5882 Hz
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShamDevice
Frequency Setting - Sham
1200 HzDevice
Frequency Setting - 1200 Hz
3030 HzDevice
Frequency Setting - 3030 Hz
5882 HzDevice
Frequency Setting - 5882 Hz
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Frequency Setting - Sham Receives: Device: Sham |
| 1200 Hz | Experimental | Frequency Setting - 1200 Hz Receives: Device: 1200 Hz |
| 3030 Hz | Experimental | Frequency Setting - 3030 Hz Receives: Device: 3030 Hz |
| 5882 Hz | Experimental | Frequency Setting - 5882 Hz Receives: Device: 5882 Hz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adnan Al-Kaisy, Dr., Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750229
- Sponsor's protocol ID
- 1668
- Status last verified
- May 2017
- First submitted
- 19 Nov 2012
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
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.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01750229
- Acronym / sponsor ID
- 1668
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: ShamFrequency Setting - Sham |
| 1200 Hz | Experimental | Device: 1200 HzFrequency Setting - 1200 Hz |
| 3030 Hz | Experimental | Device: 3030 HzFrequency Setting - 3030 Hz |
| 5882 Hz | Experimental | Device: 5882 HzFrequency Setting - 5882 Hz |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShamFrequency Setting - Sham | Device | Sham |
| 1200 HzFrequency Setting - 1200 Hz | Device | 1200 Hz |
| 3030 HzFrequency Setting - 3030 Hz | Device | 3030 Hz |
| 5882 HzFrequency Setting - 5882 Hz | Device | 5882 Hz |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34854473O'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.
- Individual participant dataSharing planned: No
Related trials for Failed Back Surgery Syndrome
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Failed Back Surgery Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Al-Kaisy, Dr. principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1200 Hz, 3030 Hz and 5882 Hz in people with Failed Back Surgery Syndrome, run by MedtronicNeuro at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) on Back Pain (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.