Wireless Spinal Cord Stimulation for Chronic Pain
- Conditions
- Back Pain
- Interventions
- Device: Freedom SCS System
- Registration Number
- NCT02514590
- Lead Sponsor
- Curonix LLC
- Brief Summary
The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Subject is ≥ 18 years of age at time of informed consent;
- Subjects have been diagnosed with chronic back or back and leg pain with an average VAS > 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary;
- Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
- Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
- Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- Subject is male or non-pregnant female;
- Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
- Subject is capable of giving informed consent;
- Subject lives within reasonable distance from the study site (circumference of 50 miles).
- Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
- Unresolved Malignancies in last six months;
- Subject has post-herpetic neuralgia (shingles);
- Subject has an active systemic infection or is immune-compromised;
- Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
- Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
- Bleeding complications or coagulopathy issues;
- Pregnant/lactating or not using adequate birth control;
- A life expectancy of less than one year;
- Any active implanted device whether turned off or on;
- A previous SCS experience;
- Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Freedom SCS System - 1500 HZ Freedom SCS System Epidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area.
- Primary Outcome Measures
Name Time Method Pain Score 6 Months A 50% reduction in VAS scores when compared to baseline.
- Secondary Outcome Measures
Name Time Method Oswestry Disability Index (ODI) Score 6 Months The change from baseline in functionality using the ODI
Sleep Quality 6 Months Frequency of sleep disturbances reported from diary
Procedure time 7 Days post implant The time measured to implant the device from operative notes
Patient Satisfaction 6 Months The change in satisfaction as measured by Patient Global Impression of Change
Disability Score 6 Months The change in European Quality of Life 5 Dimension
Opioid Reduction 6 Months The reduction in opioids as reported by patient prescription
Adverse Events 6 Months The incidence of device related adverse events
Percentage change in VAS Back from baseline 6 Months The percentage reduction in VAS back pain
Percentage change in VAS Leg from baseline 6 Months The percentage reduction in VAS leg pain
Trial Locations
- Locations (7)
USC Spine Center, Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Compass Research
🇺🇸Orlando, Florida, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Nuvo Spine and Sports Institute & Ortho Regenerative Center
🇺🇸Beverly Hills, California, United States
Anesthesia Pain Care Consultants
🇺🇸Tamarac, Florida, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States