Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spinal cord stimulation | Failed back surgery syndrome patients will receive high density spinal cord stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal cord stimulation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity with the Numeric Rating Scale (NRS) | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | |
| Pain relief by pain medication | Questionnaire regarding the amount of pain relief by pain medication | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| The abilities in daily living | The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire. | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| The current health status | The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire. | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| Subjective sleep quality | Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| Patient's satisfaction | Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain area coverage | The patient has to draw the areas of pain coverage on a body shape figure | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| Paresthesia threshold |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26344573 | Background | Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6. | |
| 26481726 | Background | Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Patient indicates the threshold at which he experiences paresthesia
| The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| HD stim parameters | Questionnaire towards the clinician regarding the ideal high density parameters for this patient | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| Battery efficiency of the neurostimulator | The battery usage will be measured by frequencies to recharge the battery. | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| AdaptiveStim use (in case of Restore Sensor) | Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| MRI need | Questionnaire regarding the need for MR scans for other medical conditions | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. |
| 35551868 | Derived | Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10. |
| 32910099 | Derived | Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |