Completed

PROMISEProspective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Spinal Cord Stimulation (SCS)

+ Optimal Medical Management (OMM)

+ Optimal Medical Management (OMM)

DeviceDrug
Who is being recruted

Neurologic Manifestations+5

+ Pain

+ Pathologic Processes

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorMedtronicNeuro
Last updated: July 21, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 8, 2013

Actual date on which the first participant was enrolled.

The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments: SCS group (SCS+OMM) OMM group

NCT01697358
Principal SponsorMedtronicNeuro
Last updated: July 21, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

278 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainFailed Back Surgery Syndrome

Criteria

5 inclusion criteria required to participate
Average low back pain is >= 5 as assessed by the baseline NPRS
Average low back pain is greater than leg pain
Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
SCS candidate with the Specify 5-6-5 surgical lead
Show More Criteria
9 exclusion criteria prevent from participating
Investigator suspects substance abuse that might confound the study results
Life expectancy of < 24 months
Low back pain only (no leg pain)
Most recent back surgery < 6 months ago
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan

Group II

Active Comparator
The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 28 locations

Pain Care LLC

Stockbridge, United StatesOpen Pain Care LLC in Google Maps

The Neuroscience Center

Ocean Springs, United States

Kozmary Center for Pain Management

Las Vegas, United States

Albany Medical College

Albany, United States
Completed28 Study Centers