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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).
Prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 Hz, 3030 Hz, and 5882 Hz.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | Frequency Setting - Sham |
|
| 1200 Hz | Experimental | Frequency Setting - 1200 Hz |
|
| 3030 Hz | Experimental | Frequency Setting - 3030 Hz |
|
| 5882 Hz | Experimental | Frequency Setting - 5882 Hz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham | Device | Frequency Setting - Sham |
| |
| 1200 Hz |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adnan Al-Kaisy, Dr. | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St. Thomas' NHS Foundation Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34854473 | Derived | 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. |
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A total of 23 subjects discontinued prior to randomization due to eligibility criteria not met or withdrawal from the study.
A total of 53 subjects were recruited between January 2013 and April 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Randomized Subjects | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Crossover Phase |
|
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| Long-term Follow-up Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Phase Subjects | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per-protocol population, subjects who followed the protocol and provided data for all four randomized crossover period were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
Randomized crossover phase of 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neuro Clinical Trials | Medtronic Neuromodulation | medtronicneurotrials@medtronic.com |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| Device |
Frequency Setting - 1200 Hz |
|
| 3030 Hz | Device | Frequency Setting - 3030 Hz |
|
| 5882 Hz | Device | Frequency Setting - 5882 Hz |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline VAS back pain score | 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 7 days in the diary were used for summary. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 1200 Hz | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. |
| OG002 | 3030 Hz | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. |
| OG003 | 5882 Hz | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 1200 Hz | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. | 0 | 24 | 1 | 24 | 0 | 24 |
| EG002 | 3030 Hz | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. | 0 | 24 | 0 | 24 | 2 | 24 |
| EG003 | 5882 Hz | Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. | 0 | 24 | 1 | 24 | 0 | 24 |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
The Trust and/or the PI may prepare the data derived from the study for publication. Data will be submitted to the Sponsor for review and comment prior to publication and at least sixty (60) days prior to submission for publication, public dissemination, or review by a publication committee.
All reasonable comments made by the Sponsor in relation to a proposed publication will be incorporated by the Trust and/or the Investigator into the publication.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |