Objectives
Bladder pain syndrome (BPS) is a debilitating condition which can be difficult to diagnose and treat due to the lack of consensus on aetiology, definition, and management. The aim of this ...review is to summarise the findings from major national and international guidelines on the management of BPS, highlighting areas of disagreement and uncertainty.
Methods
We performed a Medline/PubMed search from 1st January 2000 to 31st December 2017 in order to identify relevant guidelines addressing BPS/interstitial cystitis. We also manually searched the websites of major national and international societies. The following guidelines were included in this review: European Association of Urology, American Urological Association, International Society for the Study of BPS, International Consultation on Incontinence, International Continence Society, East Asian guideline, Royal College of Obstetricians and Gynaecologists/British Society of Urogynaecology, and the Canadian Urological Association.
Results
There is disagreement between guidelines on the exact definition of BPS and the nomenclature to use to describe this condition. However, all agree that the diagnosis is dependent on the presence of pain, pressure, or discomfort, in addition to at least one urinary symptom, in the absence of other diseases that could cause pain. Exclusion of other pathology that could cause similar symptoms requires thorough evaluation, and is recommended in all guidelines. There is also disparity in the recommended diagnostic investigation of BPS, with hydrodistension and bladder biopsy either recommended, considered optional, or not recommended, by different guidelines. It is accepted that BPS can be diagnosed clinically, without invasive investigation, but cystoscopy and diagnostic hydrodistension aids sub‐typing of patients and may help direct treatment strategies. Patients should be phenotyped in order to direct multimodal treatment (including behavioural, physical, emotional, and psychological therapy), and treatments should follow a stepwise approach starting with the most conservative. Although widely performed, hydrodistension as a therapeutic strategy has a limited evidence base and is unlikely to provide long‐term resolution of symptoms
Conclusion
There are multiple national and international guidelines for the diagnosis and management of BPS, and this review has highlighted the differences in nomenclature, definitions, and recommended diagnostic tests between guidelines. The overall evidence base for the majority of treatments for BPS/IC is of low‐quality, and larger randomised trials are required to more accurately inform guideline recommendations and clinical management of this complex group of patients.
The increasing use of high frequency paresthesia-free spinal cord stimulation has been associated with improved outcomes in the therapy of neuropathic pain. What is unknown is the effect of varying ...frequency on pain relief and the placebo effect.
This is a prospective, randomized, sham-controlled double blind crossover study. Subjects with predominantly axial low back pain undergoing spinal cord stimulation therapy for failed back surgery syndrome were randomized to sham, 1200 Hz, 3030 Hz, and 5882 Hz with a four-phase crossover design over 12 weeks.
Twenty-four patients were randomized in the study. The mean low back pain score at baseline was 7.75. The mean low back pain scores on a 10 cm visual analog scale during the randomized crossover phase were 4.83, 4.51, 4.57, and 3.22, for sham, 1200 Hz, 3030 Hz, and 5882 Hz, respectively, with the lowest low back pain score observed in the 5882 Hz frequency group (p = 0.002). Of note, sham stimulation resulted in a reduction of pain by -2.92 cm and was not significantly different from stimulation at 1200 Hz and 3030 Hz.
This randomized crossover study demonstrated that 5882 Hz stimulation can produce significant pain relief for axial low back pain compared with lower frequencies and sham stimulation. Sham stimulation produced similar analgesic effects to 1200 Hz and 3030 Hz and this effect may influence future neuromodulation clinical trial designs.
Chronic pain is a common condition that affects the physical, emotional, and mental well‐being of patients and can significantly diminish their quality of life. Due to growing concerns about the ...substantial risks of long‐term opioid use, both governmental agencies and professional societies have recommended prioritizing the use of nonpharmacologic treatments, when suitable, in order to reduce or eliminate the need for opioid use. The use of 10 kHz spinal cord stimulation (10 kHz SCS) is one such nonpharmacologic alternative for the treatment of chronic, intractable pain of the trunk and limbs. This review examines published clinical data regarding the efficacy of 10 kHz SCS for decreasing chronic pain in patients and its potential to reduce or eliminate opioid usage. Multiple prospective and retrospective studies in patients with intractable pain demonstrated that 10 kHz SCS treatment provided ≥50% pain relief in >70% patients after at least 1 year of treatment. Pain relief with 10 kHz SCS therapy ranged from 54% to 87% in the studies. More importantly, the mean daily dose of opioids required by patients in these studies was reduced after 10 kHz SCS treatment, and on average over 60% patients in studies either reduced or eliminated opioids at the last follow‐up.
The use of 10 kHz spinal cord stimulation (10 kHz SCS) is a nonpharmacologic alternative for the treatment of chronic, intractable pain of the trunk and limbs. This review examines published clinical data regarding the efficacy of 10 kHz SCS for decreasing chronic pain in patients and its potential to reduce or eliminate opioid usage.
Objective
The aim of this study was to investigate the long‐term efficacy and safety of paresthesia‐free high‐frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic, intractable ...pain of the low back and legs.
Design
Prospective, multicenter, observational study.
Method
Patients with significant chronic low back pain underwent implantation of a spinal cord stimulator capable of HF10 SCS. Patients' pain ratings, disability, sleep disturbances, opioid use, satisfaction, and adverse events were assessed for 24 months.
Results
After a trial period, 88% (72 of 82) of patients reported a significant improvement in pain scores and underwent the permanent implantation of the system. Ninety percent (65 of 72) of patients attended a 24‐month follow‐up visit. Mean back pain was reduced from 8.4 ± 0.1 at baseline to 3.3 ± 0.3 at 24 months (P < 0.001), and mean leg pain from 5.4 ± 0.4 to 2.3 ± 0.3 (P < 0.001). Concomitantly to the pain relief, there were significant decreases in opioid use, Oswestry Disability Index score, and sleep disturbances. Patients' satisfaction and recommendation ratings were high. Adverse Events were similar in type and frequency to those observed with traditional SCS systems.
Conclusions
In patients with chronic low back pain, HF10 SCS resulted in clinically significant and sustained back and leg pain relief, functional and sleep improvements, opioid use reduction, and high patient satisfaction. These results support the long‐term safety and sustained efficacy of HF10 SCS.
Objective
The objective of this prospective, open‐label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes ...high‐frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs.
Material and Methods
Eighty‐three patients, with significant back pain, were recruited for a trial of high‐frequency stimulation through two percutaneous eight‐contact epidural leads. Patients' pain ratings, disability, sleep disturbances, and satisfaction, as well as complication rates, were assessed for up to six months.
Results
After a trial period, 88% (72 out of 82) of patients reported a significant improvement in visual analog scale (VAS) scores and underwent permanent implantation of the high‐frequency SCS system. Mean back pain VAS of 8.4 was reduced to 2.7 at six months (p< 0.001). Mean leg pain VAS of 5.4 was reduced to 1.4 at six months (p< 0.001). Seventy‐four percent of patients had greater than 50% back pain relief at six months. There were significant improvements in Oswestry disability score and sleep, and reductions in pain medication use. Adverse events observed were those seen with conventional SCS therapy—lead migration, wound infection, and pain around implant site.
Conclusions
In a cohort of patients with difficult‐to‐treat chronic back pain, high‐frequency SCS provided significant and sustained low back pain and leg pain relief to more than 70% of treated subjects. Notably, this was achieved without paresthesia. Patients also experienced significant improvement in disability and sleep. Overall, the results confirm a favorable safety and efficacy profile of the high‐frequency SCS system.
Objectives
We aimed to evaluate the safety and effectiveness of sphenopalatine ganglion pulsed radiofrequency (SPG‐PRF) for the treatment of patients with refractory chronic short‐lasting unilateral ...neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and with cranial autonomic symptoms (SUNA).
Background
SPG‐PRF is a minimally invasive, non‐neurodestructive procedure already tested in refractory chronic cluster headache with mixed outcomes. However, no data have been produced in SUNCT/SUNA.
Methods
This was a prospective clinical audit of outcomes. Consecutive patients with chronic SUNCT/SUNA refractory to medical treatments and treated with SPG‐PRF, were included in the analysis. The SPG‐PRF was performed percutaneously via a lateral, infra‐zygomatic approach. Responders were defined as patients with a reduction in number and/or severity of headache episodes by ≥30% for ≥3 months. Responders to the first procedure were offered to have the treatment repeated.
Results
Nine patients (6 female) were analyzed. After a median follow‐up of 30 months (range 2‐30), 7 patients were considered responders to the treatment (77.8%) for a median of 6 months (range: 4‐10), 1 patient obtained 40% improvement for 2 months, and 1 patient did experience any improvement. No procedure‐related immediate or delayed side effects were reported. Three patients (33.3%) experienced a worsening of the head pain for 2‐4 weeks immediately after the procedure. Four responders had SPG‐PRF repeated; a reproducible response was obtained in two of them.
Conclusions
In our small series of patients with refractory chronic SUNCT/SUNA, SPG‐PRF was a safe and effective treatment modality. The potential reproducible positive effect of subsequent treatments may prevent or delay the use of more invasive and costly interventions for at least a proportion of these patients.
Abstract
Objective
This prospective, open-label study was designed to evaluate the long-term effectiveness of 10-kHz high-frequency spinal cord stimulation (SCS) in the treatment of chronic axial low ...back pain with no history of spinal surgery.
Methods
Patients with chronic low back pain without previous spinal surgery underwent assessment by a multidisciplinary pain and surgical team to confirm eligibility. After a successful temporary trial of 10-kHz HF-SCS therapy, defined by ≥50% back pain reduction, enrolled subjects underwent permanent system implantation and were followed up for 36 months. Outcome measures consisted of a 100-mm visual analog scale (VAS) for pain intensity, the Oswestry Disability Index (ODI), and a standard measure of health-related quality of life.
Results
Twenty-one patients satisfied the inclusion/exclusion criteria. Following a temporary trial, 20 of 21 (95%) subjects were implanted with a pulse generator, and 17 of 20 reached the 36-month time point. From baseline to 36 months, the average VAS pain intensity decreased from 79 ± 12 mm to 10 ± 12 mm, the average ODI score decreased from 53 ± 13 to 19.8 ± 13, and use of opioids decreased from 18 subjects to two subjects. One subject was deceased, unrelated to the study, one subject was explanted due to loss of effectiveness, and one subject was lost to follow-up.
Conclusions
These results suggest that 10-kHz high-frequency SCS may provide significant, long-term back pain relief, improvement in disability and quality of life, and reduction in opioids for nonsurgical refractory back pain.
Ten kilohertz spinal cord stimulation (SCS) is usually initiated in a single-bipolar configuration over the radiological reference point T9/T10 intervertebral disc space for neuropathic back and leg ...pain. Cascade is a duty-cycled, multi-bipolar contact configuration across an entire eight-contact lead. Potential advantages by using a broader area of SCS coverage include mitigation against minor lead migration and a reduction in the need for reprogramming. We report here the results of a retrospective case series of 114 patients using Cascade.
Retrospective data were collected over two years. We selected patients with neuropathic back with or without/leg pain who had a trial of SCS. Pain assessments using Numerical Rating Scales (NRS) and Patient Global Impression of Change (PGIC) scores were collected at baseline, six months, and last follow-up beyond 12 months (mean 15.1 months). Patients were programmed with 10 kHz SCS using Cascade during the trial, which was continued unless reporting inadequate pain relief. Morbidity and deviations from Cascade programming were also obtained.
At six months, 87 of 97 (90.6%) patients with active devices were using Cascade and 58 of 72 (81%) patients at the last follow-up >12 months. There was a significant reduction in back NRS (8.3 vs. 3.9 p < 0.0001, N = 97) and leg pain (7.53 vs. 3.83 p < 0.0001, N = 77) at 6 months and last follow-up >12 months back (8.3 vs. 3.95 p < 0.0001 N = 72), leg (7.53 vs. 3.534 p < 0.0001, N = 58). The PGIC score was 6 of 7 or all of 7 in 72% of patients (70/97) at six months and in 68% (49/72) of patients at the last follow-up beyond 12 months.
Cascade is an effective programming methodology that may have benefits over a single-bipole configuration for 10 kHz SCS, particularly during a trial of stimulation. Results from this study suggest it is a durable program for patients with neuropathic back and leg pain.
Introduction
In this prospective, multicenter, double‐blinded, randomized, crossover study, we compared the therapeutic efficacy of burst SCS delivered using a lead implanted with the paresthesia ...mapping approach to a lead implanted with an anatomic placement approach.
Materials and Methods
Subjects with chronic low back pain were implanted with two leads, one using paresthesia‐mapping approach (PM) and the second using anatomical placement procedure (AP). Stimulation contacts were chosen using the standard intraoperative paresthesia‐testing procedure for the paresthesia‐mapped lead or an activated bipole overlapping the T9‐T10 junction for the anatomical lead. Amplitude for either lead was selected such that no sensory percepts were generated. Subjects were assessed at baseline and after a trial period during which they tested each lead for two weeks in random order. Eligible subjects had the option to receive permanent implants using their preferred AP or PM approach at end‐of‐trial.
Results
Of the 53 subjects who completed both trial periods, 43 (81.1%) experienced at least 50% back pain relief with at least one lead. Nearly half of these (20; 46.5%) were profound responders who experienced at least 80% back pain relief with either leads. Primary and secondary outcomes, at the end of trial, showed significant improvements for both AP and PM leads from baseline yet were not significantly different from each other.
Discussion
The trial results of this study suggest that similar clinical outcomes can be achieved in burst SCS when performing lead placement either using paresthesia mapping or anatomical placement with imaging references.
To explore the effectiveness of 10 kHz high frequency spinal cord stimulation (HF10 therapy) treatment of chronic low back pain in patients who have not had spinal surgery.
Patients with chronic low ...back pain without prior spinal surgery were evaluated by a team of spine surgeons to rule out any spinal pathology amenable to surgical interventions and by a multidisciplinary pain team to confirm eligibility for the study. After a successful (>50% back pain reduction) trial of HF10 therapy, enrolled subjects underwent permanent system implantation and were followed-up one year post-implant.
About 95% of the enrolled subjects (20/21) received the permanent system. At 12 months post-implant, both back pain VAS score and ODI were significantly reduced compared with baseline values (by 73% and 48%, respectively); an estimated quality-adjusted life year gain of 0.47 and a reduction in opioid use by 64% was observed. Four more patients among those unable to work at baseline due to back pain were employed at 12 months post-implant. There were no serious adverse events.
HF10 therapy may provide significant back pain relief, reduction in disability, improvement quality of life, and reduction in opioid use in chronic low back pain not resulting from spinal surgery.
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