Clinical trial NCT05466110: Spinal Cord Stimulation Versus Instrumentation for FBSS
Official title: sPinal coRd stimulatiOn coMpared With Lumbar InStrumEntation for Low Back Pain After Previous Lumbar Decompression (PROMISE): a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Failed Back Surgery Syndrome
SCS
Neuromodulation
Spinal Cord Stimulation
Spinal Fusion
Low Back Pain
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2022-07-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oswestry disability index / ODI
timeFrame: 12 months after intervention
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months after intervention
measure: SF36
timeFrame: 12 months after intervention
measure: EuroQOL 5D
timeFrame: 12 months after intervention
measure: hospital length of stay
timeFrame: through study completion, an average of 2 years
measure: Crossover rates
timeFrame: 12 months after intervention
measure: Pain medication
timeFrame: 12 months after intervention
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg Department of Neurosurgery
state: Bavaria
Study officials:
References:
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citation: Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
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