Wireless Spinal Cord Stimulation for Chronic Pain

Back Pain Clinical Trial

Official title:

Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514590
• Other study ID #: 30-00113
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: October 2021
• Source: Stimwave Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Nuvo Spine and Sports Institute & Ortho Regenerative Center	Beverly Hills	California
United States	Cleveland Clinic	Cleveland	Ohio
United States	USC Spine Center, Keck Hospital of USC	Los Angeles	California
United States	Compass Research	Orlando	Florida
United States	Anesthesia Pain Care Consultants	Tamarac	Florida
United States	Precision Spine Care	Tyler	Texas
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (8)

Lead Sponsor	Collaborator
Stimwave Technologies	Anesthesia Pain Care Consultants, Tamarac, FL, USA, Compass Research LLC, Orlando, FL, USA, Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA, Precision Spine Care, Tyler, TX, USA, The Center for Clinical Research, Winston-Salem, NC, The Cleveland Clinic, USC Spine, Keck hospital of USC, Los Angeles, CA, USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	A 50% reduction in VAS scores when compared to baseline.	6 Months
Secondary	Percentage change in VAS Back from baseline	The percentage reduction in VAS back pain	6 Months
Secondary	Percentage change in VAS Leg from baseline	The percentage reduction in VAS leg pain	6 Months
Secondary	Oswestry Disability Index (ODI) Score	The change from baseline in functionality using the ODI	6 Months
Secondary	Patient Satisfaction	The change in satisfaction as measured by Patient Global Impression of Change	6 Months
Secondary	Disability Score	The change in European Quality of Life 5 Dimension	6 Months
Secondary	Sleep Quality	Frequency of sleep disturbances reported from diary	6 Months
Secondary	Procedure time	The time measured to implant the device from operative notes	7 Days post implant
Secondary	Opioid Reduction	The reduction in opioids as reported by patient prescription	6 Months
Secondary	Adverse Events	The incidence of device related adverse events	6 Months