Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Back Pain; Pain in Leg, Unspecified; Failed Back Surgery Syndrome

Treatments: Device: Spinal Cord Stimulation (SCS); Drug: Optimal Medical Management (OMM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697358

1665

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Full description

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

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SCS candidate with the Specify 5-6-5 surgical lead
• 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)
• Average low back pain is ≥ 5 as assessed by the baseline NPRS
• Average low back pain is greater than leg pain
• Subject has persistent moderate to severe low back and leg pain despite other treatments

Exclusion criteria

• Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
• Most recent back surgery < 6 months ago
• Low back pain only (no leg pain)
• Investigator suspects substance abuse that might confound the study results
• Radiographic evidence of instability requiring fusion
• Pain relieved completely by lying down
• Life expectancy of < 24 months
• Subject is pregnant or planning to become pregnant during the course of the study
• Subject is unable to undergo study assessments or complete questionnaires independently

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

SCS + OMM

Active Comparator group

Description:

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

Treatment:

Drug: Optimal Medical Management (OMM)

Device: Spinal Cord Stimulation (SCS)

OMM alone

Active Comparator group

Description:

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

Treatment:

Drug: Optimal Medical Management (OMM)