ClinicalTrials.Veeva

Menu
The trial is taking place at:
M

MedPharmics, LLC | Metairie, LA

Veeva-enabled site

SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery (SOLIS)

Boston Scientific logo

Boston Scientific

Status

Active, not recruiting

Conditions

Chronic Pain

Treatments

Other: Conventional Medical Managament
Device: WaveWriter

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.

Enrollment

241 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Chronic low back pain, with or without leg pain, for at least 6 months
  • Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
  • If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
  • Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

  • Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
  • Require implantation of lead(s) in the cervical epidural space
  • Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
  • Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

241 participants in 2 patient groups

Spinal Cord Stimulation
Experimental group
Description:
To receive Spinal Cord Stimulation programming
Treatment:
Device: WaveWriter
Conventional Medical Management
Other group
Description:
To receive conventional medical management
Treatment:
Other: Conventional Medical Managament

Trial documents
1

Trial contacts and locations

23

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems