Wireless Spinal Cord Stimulation for Chronic Pain
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|ClinicalTrials.gov Identifier: NCT02514590|
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : October 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Back Pain||Device: Freedom SCS System||Not Applicable|
This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted.
Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system.
Stimulators will be placed at the following sites to target the painful area:
• Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||July 2019|
Experimental: Freedom SCS System - 1500 HZ
Epidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area.
Device: Freedom SCS System
This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy.
- Pain Score [ Time Frame: 6 Months ]A 50% reduction in VAS scores when compared to baseline.
- Percentage change in VAS Back from baseline [ Time Frame: 6 Months ]The percentage reduction in VAS back pain
- Percentage change in VAS Leg from baseline [ Time Frame: 6 Months ]The percentage reduction in VAS leg pain
- Oswestry Disability Index (ODI) Score [ Time Frame: 6 Months ]The change from baseline in functionality using the ODI
- Patient Satisfaction [ Time Frame: 6 Months ]The change in satisfaction as measured by Patient Global Impression of Change
- Disability Score [ Time Frame: 6 Months ]The change in European Quality of Life 5 Dimension
- Sleep Quality [ Time Frame: 6 Months ]Frequency of sleep disturbances reported from diary
- Procedure time [ Time Frame: 7 Days post implant ]The time measured to implant the device from operative notes
- Opioid Reduction [ Time Frame: 6 Months ]The reduction in opioids as reported by patient prescription
- Adverse Events [ Time Frame: 6 Months ]The incidence of device related adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514590
|United States, California|
|Nuvo Spine and Sports Institute & Ortho Regenerative Center|
|Beverly Hills, California, United States, 90212|
|USC Spine Center, Keck Hospital of USC|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Orlando, Florida, United States, 32806|
|Anesthesia Pain Care Consultants|
|Tamarac, Florida, United States, 33301|
|United States, North Carolina|
|The Center for Clinical Research|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Precision Spine Care|
|Tyler, Texas, United States, 75701|
|Principal Investigator:||Nagy Mekhail||The Cleveland Clinic|