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Background: Extensive decompression with laminectomy, where appropriate, is often still described as the method of choice when operating on degenerative lumbar spinal stenosis. Nonetheless, tissue-sparing procedures are becoming more common. Endoscopic techniques have become the standard in many areas because of the surgical advantages they offer and the benefits for rehabilitation. One key issue when operating on the spine was the development of instruments to provide sufficient bone resection under continuous visual control. This was achieved by using endoscopes for operations carried out in cases of spinal canal stenosis. Objective: This study of patients with degenerative lumbar central spinal stenosis compares the results of spinal decompression using the full-endoscopic interlaminar technique (FI) with a conventional microsurgical laminotomy technique (MI). Study Design: Prospective, randomized, controlled study. Settings: 135 patients with microsurgical or full-endoscopic decompression were followed up for 2 years. Alongside general and specific parameters, the following measuring instruments were also used for the investigation: Visual Analog Scale (VAS), German version of the North American Spine Society Instrument (NASS), Oswestry Low-Back-Pain-Disability Questionnaire (ODI). Results: Postoperatively 72 % of the patients no longer had leg pain or the pain was almost completely reduced and 21.2 % experienced occasional pain. The clinical results were the same in both groups. The rate of complications and revisions was significantly reduced in the FI Group. The full-endoscopic techniques brought advantages in the following areas: operation, complications, traumatization, rehabilitation. Limitations: Lack of placebo control group. Conclusions: The recorded results demonstrate that the full-endoscopic interlaminar bilateral decompression adopting a unilateral approach provides an adequate and safe supplement and alternative to the conventional microsurgical bilateral laminotomy technique when the indication criteria are fulfilled. At the same time, it offers the advantages of a minimally invasive intervention. Key words: Spinal stenosis, central stenosis, spinal decompression, endoscopic spinal decompression, minimally invasive spine surgery

PurposeTo evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP.MethodsA total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25–69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months.ResultsAt 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.ConclusionPatients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.

Introduction The Desarda autologous tissue repair is comparable to the Lichtenstein hernioplasty for inguinal hernia regarding recurrence, chronic groin pain, and return to work activities. This study was designed to establish the outcomes of Desarda's repair versus Lichtenstein's hernioplasty concerning post-operative recovery to normal gait and its feasibility under local anesthesia (LA). Materials and methods This study was a single-center, prospective, double-blinded, non-inferiority, randomized trial. Patients undergoing open hernia repair for primary inguinal hernia were included. Patients were randomly assigned and followed up for 2 years. The primary endpoint was the time to return to normal gait post-surgery with comfort (non-inferiority margin fixed as 0.5 days). The secondary outcomes studied were post-operative pain score, the time required to return to work (all previously performed activities), and surgical-site occurrences (SSO). Results One hundred ten eligible patients were randomly assigned [56 patients (50.9%) in the Desarda group and 54 patients (49.1%) in the Lichtenstein group]. All the procedures were safely performed under LA. The median (interquartile range) time for resuming gait post-surgery with comfort was 5 days in the Desarda vs 4 days in Lichtenstein's arm ( P  = 0.16), thereby failing to demonstrate non-inferiority of Desarda against Lichtenstein hernioplasty. However, there were no significant differences in days to return to work, SSO, chronic groin pain, and recurrence within two years of surgery. Conclusions and relevance This study could not demonstrate the non-inferiority of the Desarda repair versus Lichtenstein hernioplasty regarding the time taken to return to normal gait. Comparing the days to return to work, pain score, SSO, and chronic groin pain, including recurrence rate, Desarda repair faired equally with Lichtenstein hernioplasty, thereby highlighting its feasibility and efficacy under LA. Trial registration ClinicalTrials.gov Identifier: NCT03512366.

Background The objective of this review is to evaluate the efficacy of Pulsed Radiofrequency (PRF) treatment in chronic pain management in randomized clinical trials (RCTs) and well-designed observational studies. The physics, mechanisms of action, and biological effects are discussed to provide the scientific basis for this promising modality. Methods We systematically searched for clinical studies on PRF. We searched the MEDLINE (PubMed) and EMBASE database, using the free text terms: pulsed radiofrequency, radio frequency, radiation, isothermal radiofrequency, and combination of these. We classified the information in two tables, one focusing only on RCTs, and another, containing prospective studies. Date of last electronic search was 30 May 2010. The methodological quality of the presented reports was scored using the original criteria proposed by Jadad et al. Findings We found six RCTs that evaluated the efficacy of PRF, one against corticosteroid injection, one against sham intervention, and the rest against conventional RF thermocoagulation. Two trials were conducted in patients with lower back pain due to lumbar zygapophyseal joint pain, one in cervical radicular pain, one in lumbosacral radicular pain, one in trigeminal neuralgia, and another in chronic shoulder pain. Conclusion From the available evidence, the use of PRF to the dorsal root ganglion in cervical radicular pain is compelling. With regards to its lumbosacral counterpart, the use of PRF cannot be similarly advocated in view of the methodological quality of the included study. PRF application to the supracapular nerve was found to be as efficacious as intra-articular corticosteroid in patients with chronic shoulder pain. The use of PRF in lumbar facet arthropathy and trigeminal neuralgia was found to be less effective than conventional RF thermocoagulation techniques.

Chronic low back pain (CLBP) is a common condition that can be treated with radiofrequency ablation (RFA). However, RFA can be destructive to tissue surrounding the targeted nerves. Cryoneurolysis is an alternative to RFA that applies cold temperatures to disrupt nerve conduction pathways via Wallerian degeneration, allowing for nerve regrowth. To compare the safety and efficacy of cryoneurolysis to RFA for treatment for CLBP. A randomized pilot study (NCT06016127) that received institutional review board approval from Advarra, Inc. (Pro00062787). A single center in the United States. Eligible patients with facet-mediated CLBP underwent lumbar RFA or cryoneurolysis of the lumbar medial branch nerve. The patients were originally followed for 180 days after treatment, with an optional study extension to 360 days. Study outcomes included pain scores on the numeric rating scale (NRS), functional disability status on the Oswestry Disability Index (ODI), Patient Global Impression of Change (PGIC) score, and safety. Analyses were adjusted for baseline NRS score, gender, and tobacco use. Age, body mass index, low back pain duration, and baseline ODI scores were similarly distributed between the cryoneurolysis and RFA groups (n = 15 each). At Days 180 and 360, cryoneurolysis was associated with significantly lower NRS pain scores vs. RFA (Day 180: least squares mean [LSM; 95% confidence interval (CI)], 3.1 [2.1-4.1] vs. 5.4 [4.3-6.4]; LSM difference [95% CI], -2.1 [-3.6, -0.5]; P = 0.01; Day 360: LSM [95% CI], 3.0 [1.4-4.7] vs. 6.1 [4.5-7.7]; LSM difference [95% CI], -2.7 [-4.7, -0.7]; P = 0.01). ODI scores were numerically lower in the cryoneurolysis group than in the RFA group at Day 180 (LSM [95% CI], 13.3 [8.9-17.7] vs. 18.1 [13.6-22.6]; LSM difference [95% CI], -4.8 [-11.4, 1.9]; P = 0.15) and significantly lower at Day 360 (LSM [95% CI], 10.1 [6.0-14.3] vs. 20.6 [16.5-24.7]; LSM difference [95% CI], -10.5 [-16.6, -4.3]; P = 0.002). The mean percent decrease in ODI score from the baseline was greatest at Day 360 in the cryoneurolysis group than in the RFA group (-21.7% vs. -4.0%; P = 0.42). More cryoneurolysis-treated patients than RFA-treated patients had \"no disability\" or \"mild disability\" at Day 360 (6/11 vs. 5/12). Cryoneurolysis was associated with lower PGIC scores vs. RFA at Day 180 (LSM [95% CI], 2.6 [1.6-3.7] vs. 3.6 [2.6-4.7]; LSM difference [95% CI], -0.98 [-2.5, 0.6]; P = 0.2) and Day 360 (LSM [95% CI], 1.7 [0.7-2.8] vs. 4.4 [3.3-5.4]; LSM difference [95% CI], -2.6 [-4.2, -1.1]; P = 0.002). After Day 180, 45.5% of patients (5/11) who underwent cryoneurolysis and 75% (9/12) who underwent RFA required more than one additional spinal injection. No serious adverse events were observed. One mild adverse event considered unrelated to study treatment was reported (a compression fracture in the cryoneurolysis group). The study was not blinded, and the short tip of the cryoneurolysis device restricted its use to patients with low body mass indexes. Longer device tips are in development. At 12 months after treatment for CLBP, cryoneurolysis had a favorable safety profile and led to more significant improvements in pain and functional disability than did RFA. A large multicenter trial is warranted to further investigate the effects of cryoneurolysis on CLBP.

BackgroundThe majority of patients experience uncomfortable stimulation associated with posture changes, especially when lying down. The spinal cord moves within the intrathecal space in response to positional changes affecting the size of the stimulated area accordingly and causing overstimulation or understimulation. To accommodate for positional changes, patients have to manually adjust the stimulation parameters; therefore, an automatic position-adaptive SCS was designed to address these issues. The primary objective of this study was to establish the extent of position-related variations in SCS stimulation parameters experienced by chronic pain patients implanted with surgical, laminectomy-type leads under both automatic and manual SCS conditions.MethodsA total of 18 patients completed a single-center, prospective, non-blinded, randomized (1:1), feasibility clinical study with a two-arm crossover design. All patients undergoing SCS treatment for chronic refractory back and or leg pain associated with failed back surgery, post-laminectomy, or radicular pain syndromes that were refractory to conservative and surgical interventions were eligible for enrollment. After the manual stimulation mode, the patients were randomized to one of two study arms: manual or automatic position-adaptive stimulation and then crossed over to a different arm. All patients were followed for a total of 5 months (± 2 weeks).ResultsAnalysis indicated statistically significant differences between therapeutic and threshold stimulation intensity for the supine position compared with all other body positions when using either automatic position-adaptive stimulation or manual stimulation, except for threshold amplitudes in the prone position for automatic stimulation.ConclusionSimilar variations were reported for manual and automatic stimulation intensity in response to positional changes.

Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference −1·3 points (95% CI −3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5–5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8–6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group). Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process. Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).

New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590. Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design –4·2 [95% CI –8·2 to –0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups. In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears. Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership

AbstractObjectiveTo assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation.DesignMulticentre randomised controlled trial with non-inferiority design.SettingFour hospitals in the Netherlands.Participants613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial.InterventionsPTED (n=179) compared with open microdiscectomy (n=309).Main outcome measuresThe primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses.ResultsAt 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis.ConclusionsPTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica.Trial registrationNCT02602093ClinicalTrials.gov NCT02602093.

Background Endometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain. Methods We plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons’ preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants’ preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference. Discussion This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE. Trial registration ISRCTN registry ISRCTN27244948. Registered 6 April 2021.