Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial.

Rigoard, Philippe

Basu, Surajit

Desai, Mehul

Taylor, Rod

Annemans, Lieven

Tan, Ye

Johnson, Mary Jo

Van den Abeele, Carine

North, Richard

PROMISE Study Group

2022-08-02T03:46:39Z

2022-08-02T03:46:39Z

2019-06

2022-08-02T03:46:38Z

Despite optimal medical management (OMM), low back pain (LBP) can be disabling, particularly after spinal surgery. Spinal cord stimulation (SCS) is effective in reducing neuropathic leg pain; however, evidence is limited for LBP. This prospective, open-label, parallel-group trial randomized (1:1) failed back surgery syndrome (FBSS) patients with predominant LBP to SCS plus OMM (SCS group) or OMM alone (OMM group) at 28 sites in Europe and the Americas. If trial stimulation was successful, a multicolumn SCS system was implanted. Outcomes were assessed at baseline (before randomization) and at 1, 3, 6, and 12 months after randomization. Patients could change treatment groups at 6 months. The primary outcome was the proportion of patients with ≥50% reduction in LBP (responder) at 6 months. Secondary outcomes included change in pain intensity, functional disability, and health-related quality of life (HRQoL). The results are posted at ClinicalTrials.gov under registration number NCT01697358. In the intent-to-treat analysis, there were more responders in the SCS group than in the OMM group (13.6%, 15/110 vs 4.6%, 5/108, difference 9% with 95% confidence interval 0.6%-17.5%, P = 0.036) at 6 months. The SCS group improved in all secondary outcomes compared with the OMM group. The OMM group only improved in HRQoL. In the SCS group, 17.6% (18/102) experienced SCS-related adverse events through 6 months, with 11.8% (12/102) requiring surgical reintervention. Adding multicolumn SCS to OMM improved pain relief, HRQoL, and function in a traditionally difficult-to-treat population of failed back surgery syndrome patients with predominant LBP. Improvements were sustained at 12 and 24 months.

00006396-201906000-00016

0304-3959

1872-6623

https://hdl.handle.net/10161/25564

eng

Ovid Technologies (Wolters Kluwer Health)

Pain

10.1097/j.pain.0000000000001510

PROMISE Study Group

Humans

Back Pain

Low Back Pain

Neuralgia

Pain Measurement

Neurosurgical Procedures

Prospective Studies

Quality of Life

Adult

Middle Aged

Female

Male

Failed Back Surgery Syndrome

Pain Management

Spinal Cord Stimulation

Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial.

Journal article

1410

1420

6

Duke

Fuqua School of Business

Pratt School of Engineering

School of Medicine

Clinical Science Departments

Thomas Lord Department of Mechanical Engineering and Materials Science

Institutes and Provost's Academic Units

University Institutes and Centers

Duke Institute for Brain Sciences

Initiatives

Neurosurgery

Duke Innovation & Entrepreneurship

Duke - Margolis Center for Health Policy

Innovation & Entrepreneurship Initiative

Published

160