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OpenTrials
Completed

NCT Number: NCT04676022

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitamed Research, Palm Desert, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WaveWriter

Device

To receive Spinal Cord Stimulation programming

Conventional Medical Managament

Other

To receive conventional medical management

Primary outcomes

  1. Responder Rate

    Time frame: 3 months post-activation

    Proportion of subjects with 50% or greater reduction in overall pain relief

Secondary outcomes

  1. Change in Disability (Oswestry Disability Index)

    Time frame: 3-Months post activation

    Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries

Acronym: SOLIS

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Dec 19, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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