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
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
The purpose of this study is to characterize the real-world outcomes of spinal cord stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation (SCS) System | Experimental | Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation (SCS) System | Device | Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Low Back Pain Responders | Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation | 3 months |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivek Mehta | St Bartholomew's Hospital, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schreiber Klinik | München | Germany | ||||
| Azienda Ospedale Monaldi |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation (SCS) System | Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulation (SCS) System | Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology |
| 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 | Percentage of Low Back Pain Responders | Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation | For " All subjects without outlier sites", data for those sites with outlier subjects were removed. | Posted | Count of Participants | Participants | 3 months |
|
|
Up to 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Cord Stimulation (SCS) System | Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology Spinal Cord Stimulation (SCS) System: Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roshini Jain, Director of Clinical Sciences | Boston Scientific | 6619494350 | roshini.jain@bsci.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2016 | Sep 20, 2019 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Naples |
| Italy |
| Ziekenhuis Rijnstate | Velp | Netherlands |
| Southmead Hospital Bristol | Bristol | United Kingdom |
| St. Bartholomews Hospital | London | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Average Low Back Pain Scores (NRS) | Average low back pain will be based on the 0-10 Numerical Pain Rating Scale (NRS) where 0 indicates no pain and 10 is worst pain (higher scores indicate more pain) | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| 0 |
| 73 |
| 6 |
| 73 |
| 4 |
| 73 |
| Coronary Artery Disease | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Circulatory Collapse | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D004358 |
| Drug Therapy |