Spinal Cord Stimulation Versus Instrumentation for FBSS

Not Applicable

Recruiting

• Conditions: SCS; Failed Back Surgery Syndrome; Neuromodulation; Low Back Pain; Spinal Cord Stimulation; Spinal Fusion
• Interventions: Device: Spinal Cord Stimulation; Procedure: Spinal Fusion Surgery

• Registration Number: NCT05466110
• Lead Sponsor: University Hospital Augsburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-20
• Study Start: 2023-03-20
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14
• Primary Completion: 2024-11
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation Device	Spinal Cord Stimulation	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.
Control - Lumbar Fusion surgery	Spinal Fusion Surgery	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

Primary Outcome Measures

Name	Time	Method
Oswestry disability index / ODI	12 months after intervention	A patient reported outcome measure to rate pain and disability

Secondary Outcome Measures

Name	Time	Method
hospital length of stay	through study completion, an average of 2 years	Time measured in days, counting from the first day of hospitalization until the day of discharge of the hospitalization the surgical intervention was performed. If surgery is performed as staged procedure in two separate hospitalizations (SCS) both hospitalizations are counted as described above and days are summed up.
Adverse events	12 months after intervention	Comparison of complication rates
SF36	12 months after intervention	Score to assess quality of life
EuroQOL 5D	12 months after intervention	Score to assess quality of life
Crossover rates	12 months after intervention	Rates of crossover to another therapy arm
Pain medication	12 months after intervention	Amount of analgesics taken (drug, dose, mode of application)

Trial Locations

Locations (1)

University Hospital Augsburg Department of Neurosurgery; 🇩🇪 Augsburg, Bavaria, Germany