Spinal Cord Stimulation Versus Instrumentation for FBSS (PROMISE)

University Hospital Augsburg

Status: Enrolling

Conditions: Spinal Fusion; Spinal Cord Stimulation; Neuromodulation; Low Back Pain; SCS; Failed Back Surgery Syndrome

Treatments: Device: Spinal Cord Stimulation; Procedure: Spinal Fusion Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05466110

22-0221

Details and patient eligibility

About

Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Symptomatic degenerative disc disease with LBP as a predominant symptom for at least 6 months following pervious surgery for disc herniation
• ODI score at least 21
• Correctly signed informed consent form

Exclusion criteria

• Spinal stenosis resulting in spinal claudication or neurological deficits
• Spinal Instability (> 3 mm Motion on dynamic Lumbar X-rays)
• Major psychiatric disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Spinal Cord Stimulation Device

Experimental group

Description:

The spinal cord stimulators WaveWriter AlphaTM (Boston Scientific) are designed to treat chronic back or leg pain by electrically stimulating the spinal cord. It is a well established worldwide licensed device. Percutaneous lead(-s) are implanted in the epidural space of the thoracic spine during the initial procedure. After discharge a trial phase is initiated and performed according to local preferences and standard of operations (SOPs). Patients are monitored for any complications and pain reduction. If a significant pain reduction (\>50 % on the NRS scale for back pain) is achieved, the permanent implantable pulse generator (IPG) is implanted. Otherwise if the therapy remains non-beneficial throughout the trial phase, the leads will be explanted. Patients are allowed to crossover in the fusion group at any point of time.

Treatment:

Device: Spinal Cord Stimulation

Control - Lumbar Fusion surgery

Active Comparator group

Description:

The control group needs to represent the standard of care of current practice. Gold standard is lumbar fusion surgery \[Resnik 2005\]. Surgical instrumentation will be performed according to local preferences and SOPs. Safety and efficacy of these fusion techniques have been repeatedly proven

Treatment:

Procedure: Spinal Fusion Surgery