Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2012-12-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Sham
Frequency Setting - Sham
Sham
Frequency Setting - Sham
1200 Hz
Frequency Setting - 1200 Hz
1200 Hz
Frequency Setting - 1200 Hz
3030 Hz
Frequency Setting - 3030 Hz
3030 Hz
Frequency Setting - 3030 Hz
5882 Hz
Frequency Setting - 5882 Hz
5882 Hz
Frequency Setting - 5882 Hz
Interventions
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Sham
Frequency Setting - Sham
1200 Hz
Frequency Setting - 1200 Hz
3030 Hz
Frequency Setting - 3030 Hz
5882 Hz
Frequency Setting - 5882 Hz
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Adnan Al-Kaisy, Dr.
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Guy's and St. Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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1668
Identifier Type: -
Identifier Source: org_study_id