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Status:

ACTIVE_NOT_RECRUITING

ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

Lead Sponsor:

Mainstay Medical

Conditions:

Chronic Low-back Pain

Eligibility:

All Genders

21+ years

Phase:

NA

Brief Summary

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM).

Detailed Description

This study is a prospective, randomized study comparing ReActiv8 Therapy to Optimal Medical Management (OMM), where OMM means the patient is managed according to available guideline-directed treatment...

Eligibility Criteria

Inclusion

  • Age ≥21 years
  • Evidence of lumbar multifidus muscle dysfunction
  • Intractable Chronic Low Back Pain that has persisted \>6 months resulting in pain most of the days in the past 12 months
  • Failed therapy including pain medications and physical therapy
  • Not a candidate for spine surgery
  • Low Back Pain NRS of ≥6 and ≤9
  • Oswestry Disability Index score ≥30 and ≤60
  • Willing and capable of giving Informed Consent
  • Able to comply with this protocol
  • On Optimal Medical Management per the Investigator

Exclusion

  • Contraindicated for the ReActiv8 System
  • BMI \> 35
  • Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis
  • An independent MRI assessment identifying a pathology that is likely the cause of the CLBP and is amenable to surgery
  • Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee
  • Any condition unrelated to CLBP which, in the opinion of the Investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy
  • Surgical and other procedure exclusions
  • Psycho-social exclusions
  • Protocol compliance exclusions
  • General exclusions

Key Trial Info

Start Date :

July 14 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2026

Estimated Enrollment :

203 Patients enrolled

Trial Details

Trial ID

NCT04803214

Start Date

July 14 2021

End Date

January 1 2026

Last Update

December 31 2025

Active Locations (28)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 7 (28 locations)

1

Barrow Brain & Spine

Phoenix, Arizona, United States, 85013

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

3

SoCal Sport and Spine

Newport Beach, California, United States, 92660

4

Pacific Research Institute

Santa Rosa, California, United States, 95403