SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)

Not Applicable

Completed

Conditions: Chronic Back Pain

Interventions: Device: Conventional SCS programming
Device: DTM Programming

Registration Number: NCT04571242

Lead Sponsor: SGX Nova LLC

Brief Summary: This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.

Detailed Description: This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.

Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

* Test treatment group with DTM-SCS programming approach

* Control treatment group with Conventional SCS programming approach

Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.

Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization.

This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint.

The expected total duration of this study is approximately 32 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

Inclusion Criteria

Be a candidate for SCS system (trial and implant) per labeled indication (back pain with or without leg pain)
Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent.
Be 18 years of age or older at the time of enrollment
Be on a stable pain medication regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study
Be willing to not increase pain medications from baseline through the 3-Month Visit
Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria

Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, as determined by the Investigator
Be concurrently participating in another clinical study
Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc.
Has a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Has mechanical spine instability as determined by the Investigator
Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional SCS programming	Conventional SCS programming	This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Control treatments, which may identify the type of treatment to study participants. Conventional SCS programming is stimulation parameters in the 40-250 Hz frequency range and will be trialed according to standard practice as described in the Intellis labeling/manuals
DTM-SCS programming	DTM Programming	This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test treatments, which may identify the type of treatment to study participants. DTM-SCS programming has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy	3 months	The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.

Secondary Outcome Measures