Effects of ozone applied by spinal endoscopy in patients with chronic pain related to failed back surgery syndrome: a pilot study

Abstract Objective For many medical professionals dealing with patients with persistent pain following spine surgery, the term failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading and potentially troublesome. It misrepresents causation. Alternative terms have been suggested but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS. Methods This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established. Results 14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option – Persistent spinal pain syndrome – was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification. Conclusions This project is important to those in the fields of pain management, spine surgery and neuromodulation, as well as patients labelled with FBSS. Through a shift in perspective it could facilitate the application of the new ICD-11 classification and allow clearer discussion amongst medical professionals, industry, funding organisations, academia, and the legal profession.

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Treatment Options for Failed Back Surgery Syndrome Patients With Refractory Chronic Pain

Spine ◽

10.1097/brs.0000000000002217 ◽

2017 ◽

Vol 42 ◽

pp. S41-S52 ◽

Cited By ~ 17

Author(s):

Kasra Amirdelfan ◽

Lynn Webster ◽

Lawrence Poree ◽

Vishad Sukul ◽

Porter McRoberts

Keyword(s):

Chronic Pain ◽

Treatment Options ◽

Failed Back Surgery Syndrome ◽

Failed Back Surgery ◽

Back Surgery

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Views of patients suffering from Failed Back Surgery Syndrome on their health and their ability to adapt to daily life and self-management: A qualitative exploration

PLoS ONE ◽

10.1371/journal.pone.0243329 ◽

2020 ◽

Vol 15 (12) ◽

pp. e0243329

Author(s):

Tanja E. Hamm-Faber ◽

Yvonne Engels ◽

Kris C. P. Vissers ◽

Dylan J. H. A. Henssen

Keyword(s):

Quality Of Life ◽

Chronic Pain ◽

Daily Life ◽

Failed Back Surgery Syndrome ◽

Personal Health ◽

Positive Health ◽

Failed Back Surgery ◽

Back Surgery ◽

The Web

Background The clinical outcomes of Spinal Cord Stimulation (SCS) therapy in patients with a Failed Back Surgery Syndrome (FBSS) is mostly done by standardized pain and quality of life measurements instruments and hardly account for personal feelings and needs as a basis for a patient-centred approach and shared decision making. Objectives The objective of this study is to explore perspectives on personal health and quality of life (QoL) in FBSS patients concerning their physical-, psychological and spiritual well-being prior to receiving an SCS system. Methods We performed face-to-face, semi-structured, in-depth interviews to obtain descriptive and detailed data on personal health, guided by the Web diagram of Positive Health (Huber et al.) and a topic list. The following main topics were assessed qualitatively: 1) Bodily functioning, 2) Mental function and perception 3) Spiritual dimension, 4) Quality of life, 5) Social and societal participation and 6) Daily functioning. Results Seventeen FBSS patients (eight male, nine female) were included from April–November 2019 at the department of pain medicine in the Albert Schweitzer Hospital in the Netherlands. Median age 49 years; range 28 to 67 years, and patients underwent between one and five lumbar surgical operations. The duration of their chronic pain was between four and 22 years. After analyzing the interviews, three themes emerged: 1) dealing with chronic pain, 2) the current situation regarding aspects of positive health, and 3) future perspectives on health and quality of life. These themes arose from eleven categories and a hundred ninety codes. Conclusion This qualitative study explored FBSS patients ‘views on their health and the ability to adapt to daily life having complex chronic pain, and showed that patients experienced shortcomings in daily life within the six dimensions of the Web diagram of Positive Health before the SCS implant.

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Complex Regional Pain Syndrome and Failed Back Surgery Syndrome With Failed High-Frequency Spinal Cord Stimulation Salvaged With Arthrodesis Revision Surgery and Burst Therapy

Neurosurgery ◽

10.1093/neuros/nyz310_418 ◽

2019 ◽

Vol 66 (Supplement_1) ◽

Author(s):

Erin McCormack ◽

Mansour H Mathkour ◽

Lora Wallis Kahn ◽

Maged Guirguis ◽

Gassan Chaiban ◽

...

Keyword(s):

Spinal Cord ◽

Chronic Pain ◽

Back Pain ◽

Pain Relief ◽

High Frequency ◽

Pain Syndrome ◽

Failed Back Surgery Syndrome ◽

Foot Pain ◽

Failed Back Surgery ◽

Back Surgery

Abstract INTRODUCTION Complex regional pain syndrome (CRPS) is a disabling form of constant and intense chronic pain involving a limb. Failed back surgery syndrome (FBSS) is chronic back pain following back surgery. Burst stimulation is a novel concept applied recently to treat chronic pain through spinal cord stimulation (SCS). The impulses are thought to travel to the thalamus to treat sensory, affective, and attentional components of neuropathic pain by targeting both the somatosensory cortex and the limbic system. METHODS A 50-yr-old female presented 1 yr after L5-S1 posterior instrumentation and posterolateral arthrodesis for spondylolisthesis with disabling Type I CRPS of her left foot and back pain. Postoperative improvement in back pain was noted but her left leg pain became worse despite SCS reprogramming. Two months later, she underwent placement of a different paddle lead at T12 and a new pulse generator using burst therapy. This resulted in complete resolution of foot pain. She remains pain-free 5 mo postoperatively. RESULTS Our patient underwent a T9-T10 high frequency (10 kHz) SCS trial followed by permanent paddle lead placement at T9-10 which provided more than 50% foot pain relief resulting in improved range of motion. However, worsening back pain and pseudoarthrosis mandated a revision of her prior arthrodesis 6 mo after SCS surgery. CONCLUSION In selected patients with FBSS and CRPS, revision of arthrodesis combined with SCS may be needed to achieve adequate pain relief. Burst therapy may be superior to high frequency stimulation in select patients.

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Treatment of Failed Back Surgery Syndrome Patients with Low Back and Leg Pain: A Pilot Study of a New Dual Lead Spinal Cord Stimulation System

Neuromodulation Technology at the Neural Interface ◽

10.1046/j.1525-1403.1999.00258.x ◽

1999 ◽

Vol 2 (4) ◽

pp. 258-265 ◽

Cited By ~ 53

Author(s):

Jean-Pierre Buyten ◽

Jan Zundert ◽

Germain Milbouw

Keyword(s):

Spinal Cord ◽

Pilot Study ◽

Spinal Cord Stimulation ◽

Failed Back Surgery Syndrome ◽

Leg Pain ◽

Low Back ◽

Failed Back Surgery ◽

Back Surgery ◽

Stimulation System ◽

Dual Lead

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Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study

Pain Medicine ◽

10.1093/pm/pnz019 ◽

2019 ◽

Vol 20 (10) ◽

pp. 1971-1979 ◽

Cited By ~ 3

Author(s):

Robert Bolash ◽

Michael Creamer ◽

Richard Rauck ◽

Payam Vahedifar ◽

Aaron Calodney ◽

...

Keyword(s):

Spinal Cord ◽

Chronic Pain ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Low Frequency ◽

Failed Back Surgery Syndrome ◽

Leg Pain ◽

Trial Period ◽

Failed Back Surgery ◽

Back Surgery

Abstract Background This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treatment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10–1,500-Hz stimulation (low-frequency [LF]) waveforms. Methods Ninety-nine subjects were randomized in a 1:1 ratio to receive either HF or LF stimulation waveforms utilizing the same Freedom WSCS System. All subjects were implanted with two 8-electrode arrays in the exact same anatomical positions within the dorsal epidural spinal column, with the top electrode positioned at the T8 and T9 vertebrae levels, respectively, and the wireless receiver placed under the skin in a subcutaneous pocket. Results Seventy-two (HF: N = 38; LF: N = 34) subjects had completed the six-month follow-up after an initial 30-day trial period at the time of this report. For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm. In addition, most subjects experienced significant improvements in VAS, Oswestry Disability Index, European Quality of Life 5 Dimension questionnaire, Patient Global Impression of Change, and sleep duration. Conclusions These preliminary results demonstrate that WSCS devices can reduce FBSS chronic pain substantially with both LF and HF stimulation waveforms over a seven-month period (30-day trial period and six-month post-trial evaluation).

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Exhaled-Breath Testing Using an Electronic Nose during Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: An Experimental Pilot Study

Journal of Clinical Medicine ◽

10.3390/jcm10132921 ◽

2021 ◽

Vol 10 (13) ◽

pp. 2921

Author(s):

Lisa Goudman ◽

Julie Jansen ◽

Nieke Vets ◽

Ann De Smedt ◽

Maarten Moens

Keyword(s):

Spinal Cord ◽

Pilot Study ◽

Random Forest ◽

Electronic Nose ◽

Spinal Cord Stimulation ◽

Failed Back Surgery Syndrome ◽

Exhaled Breath ◽

Outcome Measurements ◽

Failed Back Surgery ◽

Back Surgery

The increased awareness of discrepancies between self-reporting outcome measurements and objective outcome measurements within the field of neuromodulation has accelerated the search towards more objective measurements. The aim of this study was to evaluate whether an electronic nose can differentiate between chronic pain patients in whom Spinal Cord Stimulation (SCS) was activated versus deactivated. Twenty-seven patients with Failed Back Surgery Syndrome (FBSS) participated in this prospective pilot study. Volatile organic compounds in exhaled breath were measured with electronic nose technology (AeonoseTM) during SCS on and off states. Random forest was used with a leave-10%-out cross-validation method to determine accuracy of discriminating between SCS on and off states. Our random forest showed an accuracy of 0.56, with an area under the curve of 0.62, a sensitivity of 62% (95% CI: 41–79%) and a specificity of 50% (95% CI: 30–70%). Pain intensity scores were significantly different between both SCS states. Our findings indicate that we cannot discriminate between SCS off and on states based on exhaled breath with the AeonoseTM in patients with FBSS. In clinical practice, these findings imply that with a noninvasive electronic nose, exhaled breath cannot be used as an additional marker of the effect of neuromodulation.

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