Pain relief and quality-of-life improvement after spinal cord stimulation in painful diabetic polyneuropathy: a pilot study

Abstract OBJECTIVE: To present an in-depth analysis of clinical predictors of outcome including age, sex, etiology of pain, type of electrodes used, duration of pain, duration of treatment, development of tolerance, employment status, activities of daily living, psychological status, and quality of life. Suggestions for treatment of low back pain with a predominant axial component are addressed. We analyzed the complications and proposed remedial measures to improve the effectiveness of this modality. METHODS: Study group consists of 410 patients (252 men, 58 women) with a mean age of 54 years and a mean follow-up period of 97.6 months. All patients were gated through a multidisciplinary pain clinic. The study was conducted over 22 years. RESULTS: The early success rate was 80% (328 patients), whereas the long-term success rate of internalized patients was 74.1% (243 patients) after the mean follow-up period of 97.6 months. Hardware-related complications included displaced or fractured electrodes, infection, and hardware malfunction. Etiologies demonstrating efficacy included failed back syndrome, peripheral vascular disease, angina pain, complex regional pain syndrome I and II, peripheral neuropathy, lower limb pain caused by multiple sclerosis. Age, sex, laterality of pain or number of surgeries before implant did not play a role in predicting outcome. The percentage of pain relief was inversely related to the time interval between pain onset and time of implantation. Radicular pain with axial component responded better to dual Pisces electrode or Specify-Lead implantation. CONCLUSION: Spinal cord stimulation can provide significant long-term pain relief with improved quality of life and employment. Results of this study will be effective in better defining prognostic factors and reducing complications leading to higher success rates with spinal cord stimulation.

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Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

Quality of Life Research ◽

10.1007/s11136-018-1890-8 ◽

2018 ◽

Vol 27 (8) ◽

pp. 2035-2044 ◽

Cited By ~ 17

Author(s):

Kasra Amirdelfan ◽

Cong Yu ◽

Matthew W. Doust ◽

Bradford E. Gliner ◽

Donna M. Morgan ◽

...

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Spinal Cord Stimulation ◽

Leg Pain ◽

Life Improvement ◽

Pain Patients

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10 kHz spinal cord stimulation for the treatment of chronic back and/or leg pain: Summary of clinical studies

SAGE Open Medicine ◽

10.1177/2050312120951369 ◽

2020 ◽

Vol 8 ◽

pp. 205031212095136

Author(s):

Thorsten Luecke ◽

Deborah Edgar ◽

Daniel Huse

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Pain Relief ◽

Spinal Cord Stimulation ◽

Clinical Studies ◽

Response To Therapy ◽

Leg Pain ◽

Pubmed Database

Chronic pain has a major impact on sufferers and their families. The associated health care costs are substantial. In the context of increasing prevalence, effective treatment options are ever more important. 10 kHz spinal cord stimulation has been shown to effectively provide pain relief, aid in opioid reduction, and improve quality of life in patients with chronic intractable pain. The present review aims to summarize the clinical evidence related to the use of 10 kHz SCS in chronic back and/or leg pain. We searched the PubMed database between 2009 and 2 June 2020 for articles reporting clinical studies that included at least 10 human subjects permanently treated with a 10 kHz SCS system (Senza® system) for chronic back and/or leg pain for a minimum of 3 months. A randomized controlled trial (SENZA-RCT), as well as several prospective and retrospective studies, reported clinical outcomes in subjects with chronic back and leg pain treated with 10 kHz SCS. A high proportion of subjects (60%–80%) reported long-term response to therapy. Pain relief was provided without paresthesia. Other studies showed promising pain relief outcomes in subjects with back pain ineligible for spinal surgery, neuropathic limb pain, and in those with previously failed traditional low-frequency SCS. Most studies reported improved quality of life metrics and/or reduced opioid intake. Level 1 evidence has already been established for the use of 10 kHz SCS in treating chronic back and leg pain, corroborated by real-world, clinical experience. Exploratory studies also show the potential of the therapy in other refractory pain syndromes, although larger studies are desired to validate their findings. Overall, the literature suggests that 10 kHz SCS provides long-term pain relief in a high proportion of patients, along with improved quality of life and reduced opioid consumption.

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Duration of disability, functional independence, coping styles and the quality of life in patients with spinal cord injury – Pilot study

The European Journal of Psychiatry ◽

10.1016/j.ejpsy.2017.09.004 ◽

2018 ◽

Vol 32 (1) ◽

pp. 36-43

Author(s):

K. Nowakowska-Domagała ◽

T. Pietras ◽

K. Jabłkowska-Górecka ◽

P. Stecz

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Spinal Cord Injury ◽

Pilot Study ◽

Coping Styles ◽

Functional Independence ◽

Cord Injury

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Spinal Cord Stimulation With Nonlinear Burst Stimulation Design Improves Psychosocial Function Through the Medial Spinothalamic Tract

Neurosurgery ◽

10.1093/neuros/nyz310_355 ◽

2019 ◽

Vol 66 (Supplement_1) ◽

Author(s):

Steven M Falowski

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Physical Function ◽

Spinal Cord Stimulation ◽

Pain Catastrophizing ◽

Psychosocial Outcomes ◽

Burst Stimulation ◽

Spinothalamic Tract ◽

Population Norm

Abstract INTRODUCTION Tonic spinal cord stimulation (SCS) mainly modulates the lateral spinothalamic tract relaying information for quality and intensity of pain. In contrast, nonlinear burst stimulation affects the lateral, medial, and descending pain pathways. The medial spinothalamic tract has been associated with emotional and motivational aspects of pain, such as pain catastrophizing and suffering. The objective of this prospective, multi-center, single arm trial was to assess functional and psychosocial outcomes after SCS using a burst stimulation design. METHODS Eligible patients with chronic, intractable pain of the trunk and/or lower limbs were enrolled. After a successful trial period, patients received a permanent SCS implant and returned for follow-up at 6 mo. Quality of life (EQ-5D), mental health (PCS, PHQ-9), and physical function (TSK, PROMIS-8) were recorded. RESULTS 173 patients at 21 centers received a permanent implant. We observed an improvement in all functional and psychosocial outcomes compared to baseline (P < .0001). About 74% of patients achieved a result that was equal to (within 10%) or better than the population norm for at least one outcome measure. Specifically, overall quality of life (EQ-5D) improved from 0.4 to 0.7. Mean pain catastrophizing (PCS) score dropped below the population norm (14); 70% of patients who were clinically catastrophizing (score of ≥30) at baseline, were not at 6 mo. Patients who were moderately or severely depressed at baseline (n = 82) showed a clinically significant improvement to mild depression. Patients displayed an improved physical function and reduced kinesiophobia (TSK). Furthermore, 75% of patients were satisfied or very satisfied with their therapy. Finally, 68% (84/123) reduced their opioid usage at 6 mo. CONCLUSION Our study provides additional support for nonlinear burst SCS by showing this therapy improves patients' mental and physical health and quality of life. These results provide evidence that this stimulation design acts upon motivational-affective responses of pain through the medial spinothalamic tract.

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Spinal Cord Stimulation Is Effective in Management of Complex Regional Pain Syndrome I: Fact or Fiction

Neurosurgery ◽

10.1227/neu.0b013e3182181e60 ◽

2011 ◽

Vol 69 (3) ◽

pp. 566-580 ◽

Cited By ~ 71

Author(s):

Krishna Kumar ◽

Syed Rizvi ◽

Sharon Bishop Bnurs

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Functional Status ◽

Complex Regional Pain Syndrome ◽

Spinal Cord Stimulation ◽

Pain Syndrome ◽

Sf 36

Abstract BACKGROUND: Complex regional pain syndrome (CRPS) I is a debilitating neuropathic pain disorder characterized by burning pain and allodynia. Spinal cord stimulation (SCS) is effective in the treatment of CRPS I in the medium term but its long-term efficacy and ability to improve functional status remains controversial. OBJECTIVE: To evaluate the ability of SCS to improve pain, functional status, and quality of life in the long term. METHODS: We retrospectively analyzed 25 patients over a mean follow-up period of 88 months. The parameters for evaluation were visual analog scale (VAS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), EuroQoL-5D (EQ-5D) and Short Form 36 (SF-36), and drug consumption. Evaluations were conducted at point of entry, 3 months, 12 months, and last follow-up at 88 months (mean). RESULTS: At baseline, the mean scores were VAS 8.4, ODI 70%, BDI 28, EQ-5D 0.30, and SF-36 24. In general, maximum improvement was recorded at follow-up at 3 months (VAS 4.8, ODI 45%, BDI 15, EQ-5D 0.57, and SF-36 45). At last follow-up, scores were 5.6, 50%, 19, 0.57, and 40, respectively. Despite some regression, at last follow-up benefits were maintained and found to be statistically significant (P < .001) compared with baseline. Medication usage declined. SCS did not prevent disease spread to other limbs. Best results were achieved in stage I CRPS I, patients under 40 years of age, and those receiving SCS within 1 year of disease onset. CONCLUSION: SCS improves pain, quality of life, and functional status over the long term and consequently merits early consideration in the treatment continuum.

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A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation

Radiation Oncology ◽

10.1186/s13014-020-01710-4 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Elysia K. Donovan ◽

Jeffrey Greenspoon ◽

Kara L. Schnarr ◽

Timothy J. Whelan ◽

James R. Wright ◽

...

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Quality Assurance ◽

Pilot Study ◽

Spinal Cord Compression ◽

Cord Compression ◽

Significant Deterioration ◽

Advanced Malignancy ◽

Dosimetric Data

Abstract Purpose Metastatic epidural spinal cord compression (MESCC) is a devastating complication of advanced malignancy, which can result in neurologic complications and significant deterioration in overall function and quality of life. Most patients are not candidates for optimal surgical decompression and as a result, receive urgent 3D conformal radiotherapy (3DCRT) to prevent or attempt to reverse neurologic progression. Multiple trials indicate that response and ambulatory rates after 3DCRT are inferior to surgery. The advent of stereotactic body radiation therapy (SBRT) has created a method with which a “radiosurgical decompression” boost may facilitate improve outcomes for MESCC patients. Methods We are conducting a pilot study to investigate SBRT boost after urgent 3D CRT for patients with MESCC. The aim of the study is to establish feasibility of this two-phase treatment regimen, and secondarily to characterize post-treatment ambulation status, motor response, pain control, quality of life and survival. Discussion We describe the study protocol and present a case report of one patient. A quality assurance review was conducted after the first seven patients, and resultant dose-constraints were revised to improve safety and feasibility of planning through more conservative organ at risk constraints. There have been no severe adverse events (grade 3–5) to date. We have illustrated clinical and dosimetric data of an example case, where a patient regained full strength and ambulatory capacity. Conclusions Our study aims to determine if SBRT is a feasible option in addition to standard 3DCRT for MESCC patients, with the goal to consider future randomized trials if successful. Having a robust quality assurance process in this study ensures translatability going forward if future trials with multicenter and increased patient representation are to be considered. Trial registration clinicaltrials.gov; registration no. NCT03529708; https://clinicaltrials.gov/ct2/show/NCT03529708; First posted May 18, 2018.

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