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Background Most patients with cervical radiculopathy improve within the first months without treatment or with non-surgical treatment. A systematic review concluded that these patients improve, regardless of their intervention. Still, many patients are offered surgery, despite limited evidence regarding the indications for surgical treatments. The aim of this article is to describe the intervention that is going to be followed in the non-surgical treatment arm of a randomised controlled trial (RCT) comparing the effectiveness of surgical and non-surgical treatment for patients with cervical radiculopathy. Methods The non-surgical intervention is a functional intervention within a cognitive approach founded on previous experiences, and current recommendations for best practice care of musculoskeletal pain and cervical radiculopathy. It is based on the biopsychosocial rather than a biomedical perspective, comprises an interdisciplinary approach (physicians, physiotherapy specialists), and includes brief intervention and graded activities. The intervention consists of 6 sessions over 12 weeks. The primary goals are first, to validate the patients´ symptoms and build a therapeutic alliance, second, to explore the understanding and promote alternatives, and third, to explore problems and opportunities based on patients´ symptoms and function. Motivational factors toward self-management are challenging. We will attempt shared decision-making in planning progress for the individual patient and emphasise learning of practical self-help strategies and encouragement to stay active (reinforcing the positive natural course). General physical activities such as walking will be promoted along with simple functional exercises for the neck- and shoulder region. We will also explore social activity, comorbidities, pain location, sleep, and work-related factors. The health providers will set individualised goals together with each patient. Discussion The aim of the intervention is to describe a functional intervention within a cognitive approach for patients with chronic cervical radiculopathy. The effectiveness of the present program will be compared to surgery in a randomised controlled trial.

BACKGROUND:Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10 therapy) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy. OBJECTIVE:To compare long-term results of HF10 therapy and traditional low-frequency SCS. METHODS:A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ≥5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ≥50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority. RESULTS:In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < .001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P < .001 for non-inferiority and superiority; leg pain72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P < .001 for non-inferiority and P = .003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P < .001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P < .001 for non-inferiority and P = .002 for superiority). CONCLUSION:This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially. ABBREVIATIONS:IPG, implantable pulse generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog Scale

The aim of this present clinical trial is to evaluate the effectiveness of a multicomponent prehabilitation programme administered through educational videos versus another programme based on written exercise recommendations, in patients scheduled for lumbar radiculopathy surgery. This study will be a multicentre, controlled, randomised, parallel clinical trial. One hundred participants undergoing lumbar radiculopathy surgery who meet the established inclusion criteria will be recruited at different Spanish hospitals. The experimental group will follow a 4-week prehabilitation programme combining therapeutic exercise, back care education, and pain neuroscience education delivered through videos designed for consumption at home. The control group will be provided with written instructions to perform therapeutic exercises during the same prehabilitation time period. The primary outcome of the study will be disability, assessed using the Spanish version of the Oswestry Disability Index. The secondary outcomes will be pain perception, health-related quality of life, fear avoidance, kinesiophobia, catastrophising, anxiety, depression, physical activity, and the treatment satisfaction of the patients. This study will provide evidence for the effectiveness of a home-based multicomponent prehabilitation programme that addresses some already identified barriers to patient attendance in face-to-face programmes. Understanding the medium and long-term effects of pre-surgery lumbar muscle training and pain neuroscience education administered via instructional videos watched by patients at home, will help improve the design of prehabilitation programmes in this population while also improving the cost-effectiveness of such interventions.

Epidural fibrosis (EF) is one of the leading causes of post lumbar surgery syndrome (PLSS). Although there are studies in the literature suggesting that lumbar epidural steroid injections are an effective method in the pain management of PLSS caused by EF, no study is available comparing the effectiveness and safety of caudal and transforaminal approaches. To investigate the efficacy of caudal epidural steroid injection (CESI) versus transforaminal epidural steroid injection (TFESI) in patients with PLSS. A prospective, randomized, assessor-blind study. Interventional pain management center at a tertiary care center. Patients with low back and radicular pain related to EF following single-level lumbar discectomy were included. The patients were randomly divided into 2 groups: a CESI group and a TFESI group. All patients were assessed before the procedure (baseline) and at one hour, 3 weeks, and 3 months after the procedure using the Numeric Rating Scale (NRS-11) and at baseline, 3 weeks, and 3 months using the modified Oswestry Disability Index (mODI). Treatment success was defined as a >= 50% decrease in the NRS-11 scores compared to baseline. A total of 56 patients (n = 26 CESI group; n = 30 TFESI group) were included. NRS-11 and mODI scores showed a significant decline in both groups at all follow-ups (P < 0.001). At 3 weeks, the improvement in the mODI scores was significantly higher in the TFESI group (P = 0.020). In all follow-ups, the NRS-11 scores were similar between the groups. At 3 weeks, the rates of patients with a >= 50% decrease in NRS-11 scores were 53.8% and 60% in the CESI group and TFESI group, respectively, while these rates were 30% and 26.7%, respectively, at 3 months. This study had no placebo-control group and a relatively short follow-up. Both CESI and TFESI are effective and safe methods in the treatment of PLSS caused by EF following lumbar discectomy. These methods can reduce pain and disability. Although both methods have similar treatment success rates, TFESI seems to be a more effective treatment method in reducing disability at 3-week follow-up.

Background Although glucocorticoid therapy has been used in patients with lumbar radiculopathy for many years, the results of studies in literature are inconsistent. The aim of the study was to evaluate the effects of intramuscular betamethasone injection on pain, disability, quality of life and electroneuromyography (ENMG) findings in patients with lumbar radicular pain (LRP). Methods Patients with LRP ( n  = 98) were evaluated between July 2022 and June 2023. Sixty patients who met the inclusion criteria were randomized into two groups. Glucocorticoid group (GC) received intramuscular injection of betamethasone and Placebo group (PB) received isotonic sodium chloride. Visual analog scale (VAS), Oswestry disability index (ODI), Nottingham health profile (NHP) and ENMG were applied to both groups. Patients were evaluated before treatment and after first week, first month and third month of treatment. Results Significant improvements were seen in all clinical parameters in GC group. At the end of third month, VAS and NHP-Pain subscale scores improved significantly in both groups ( p  < 0.001) but the change of these values over time was statistically significant in favor of GC group ( p  = 0.03 and p  = 0.044, respectively). The significant improvements observed in ODI, Energy and Physical Mobility subscales and Total scores of NHP in both groups ( p  < 0.05) revealed no significant difference between the groups over time. The ENMG data revealed no significant difference within the groups except the fibrillation potentials, which disappeared in both groups. Conclusion Intramuscular glucocorticoid administration provided improvements on pain, disability and quality of life of patients with LRP. Especially the effects on pain scores were superior to placebo. No superiority over placebo on ENMG findings has been demonstrated and further studies are needed in this regard. Clinical trial registration The study protocol was registered to Clinicaltrials.gov with the number NCT05571046 (retrospectively registered on 30/09/2022).

Purpose For cervical nerve root compression, anterior cervical discectomy with fusion (anterior surgery) or posterior foraminotomy (posterior surgery) are safe and effective options. Posterior surgery might have a more beneficial economic profile compared to anterior surgery. The purpose of this study was to analyse if posterior surgery is cost-effective compared to anterior surgery. Methods An economic evaluation was performed as part of a multicentre, noninferiority randomised clinical trial (Foraminotomy ACDF Cost-effectiveness Trial) with a follow-up of 2 years. Primary outcomes were cost-effectiveness based on arm pain (Visual Analogue Scale (VAS; 0–100)) and cost-utility (quality adjusted life years (QALYs)). Missing values were estimated with multiple imputations and bootstrap simulations were used to obtain confidence intervals (CIs). Results In total, 265 patients were randomised and 243 included in the analyses. The pooled mean decrease in VAS arm at 2-year follow-up was 44.2 in the posterior and 40.0 in the anterior group (mean difference, 4.2; 95% CI, − 4.7 to 12.9). Pooled mean QALYs were 1.58 (posterior) and 1.56 (anterior) (mean difference, 0.02; 95% CI, − 0.05 to 0.08). Societal costs were €28,046 for posterior and €30,086 for the anterior group, with lower health care costs for posterior (€12,248) versus anterior (€16,055). Bootstrapped results demonstrated similar effectiveness between groups with in general lower costs associated with posterior surgery. Conclusion In patients with cervical radiculopathy, arm pain and QALYs were similar between posterior and anterior surgery. Posterior surgery was associated with lower costs and is therefore likely to be cost-effective compared with anterior surgery.

Background Acute lumbosacral radiculopathy from disc herniation is common and particularly painful. The challenge is to provide sufficient relief to patients until the natural regression of the herniated disc allows them to heal, primarily using conservative medical treatment combining physical measures, antinociceptive analgesics, and systemic anti-inflammatory drugs. Nerve root impingement is likely to cause acute neuropathic pain, which is not currently managed by standard conservative medical treatment. We hypothesised that a short course of gabapentin could improve pain management in acute lumbosacral radiculopathy from disc herniation. Methods The GRADE (Gabapentin versus placebo for the treatment of acute lumbosacral RAdicular pain caused by Disc hErniation) study is a prospective, randomized, multicenter, double-blind, superiority phase III trial comparing a 3-day regimen of gabapentin to placebo with a 1:1 ratio. Patients with acute lumbosacral radiculopathy from disc herniation with symptoms of less than 3 months are included in 6 centres in France. The primary outcome is the change in the radicular pain Visual Analogue Scale between Day 1 and Day 4. Intention-to-treat analysis will be applied primarily. Discussion Ethics approval was obtained from the committee for the protection of persons (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 1: 1-21-023 ID 11548). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the pain management in acute lomboradicular pain. Trial registration number EudraCT: 2020-002849-42 Clinicaltrials NCT04865042. 19 April 2021.

Background Cervical spondylosis (CS), including myelopathy and radiculopathy, is the most common degenerative cervical spine disease. This study aims to evaluate the clinical outcomes of unilateral biportal endoscopy (UBE) compared to those of conventional anterior cervical decompression and fusion (ACDF) for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs. Methods A prospective, randomized, controlled, noninferiority trial was conducted. The sample consisted of 131 patients who underwent UBE or ACDF was conducted between September 2021 and September 2022. Patients with cervical nerve roots or coexisting spinal cord compression symptoms and imaging-defined unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs were randomized into two groups: a UBE group ( n  = 63) and an ACDF group ( n  = 68). The operative time, blood loss, length of hospital stay after surgery, and perioperative complications were recorded. Preoperative and postoperative modified Japanese Orthopaedic Association (mJOA) scale scores, visual analog scale (VAS) scores, neck disability index (NDI) scores, and recovery rate (RR) of the mJOA were utilized to evaluate clinical outcomes. Results The hospital stay after surgery was significantly shorter in patients treated with UBE than in those treated with ACDF ( p  < 0.05). There were no significant differences in the neck or arm VAS score, NDI score, mJOA score, or mean RR of the mJOA between the two groups ( p  < 0.05). Only mild complications were observed in both groups, with no significant difference ( p  = 0.30). Conclusion UBE can significantly relieve pain and disability without severe complications, and most patients are satisfied with this technique. Consequently, this procedure can be used safely and effectively as an alternative to ACDF for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs. Trial registration This study was registered in the Chinese Clinical Trial Registry on 02/08/2023 ( http://www.chictr.org.cn , #ChiCTR2300074273).

Background Lumbar disc herniation (LDH) is a common chronic musculoskeletal disorder that seriously affects quality of life. The percutaneous endoscopic lumbar diskectomy (PELD) technique was developed to address spinal nerve root compression through direct visualization of pathological findings while minimizing tissue destruction upon exposure. It is an effective and safe treatment for LDH. However, recurrent LDH is a major concern after lumbar discectomy for primary LDH. A considerable number of clinical studies have reported that patients with LDH with radiculopathy could benefit from manual therapy. Shi’s manual therapy (SMT) was established based on traditional Chinese medicine (TCM) theory and has been shown to have a superior effect in alleviating muscle tension and loosening joints to improve lumbar and leg pain, radiculopathy, stiffness, activity discomfort, and related disorders. However, there is a lack of high-quality clinical evidence to support this conclusion. The purpose of this study is to evaluate the efficacy and safety of the combination of Shi’s manual therapy (SMT) and PELD for LDH with radiculopathy. Methods/design A multicenter randomized controlled trial (RCT) with a 1-year follow-up period will be performed. A total of 510 participants with LDH with radiculopathy will be recruited from four clinical centers. The sample size was estimated, and statistical analysis will be performed and supervised by biostatisticians from an independent third-party research institution. Two hundred fifty-five subjects will be randomly allocated to each group. The subjects in the control group will undergo PELD. Participants in the intervention group will be treated with a combination of SMT and PELD. Recurrence rate is the primary endpoint and the survival analysis of recurrence rate is the secondary endpoint, and the primary analysis of recurrence rate is the chi-square test and the secondary analysis of recurrence rate is survival analysis. The primary outcome measure is the recurrence rate of LDH with radiculopathy at the 1-year follow-up after treatment. The secondary outcome measures will be the ODI score, the VAS score for pain for the lumbar spine and lower limbs, the straight leg raise angle, the stability of the operated lumbar segment, and the SF-36 scores. Assessments will occur at baseline, postoperation, and 1 week, 4 weeks, 13 weeks, 26 weeks, and 1 year postoperation. In addition, adverse events related to clinical symptoms and signs and the results of laboratory tests will be documented during the clinical trials. Discussion This study will provide reliable evidence of the effectiveness and safety of the combination of SMT and PELD for LDH with radiculopathy. If the results are favorable, it is expected that patients with LDH with radiculopathy will benefit from this study, and many patients could gain a good alternative treatment for LDH with radiculopathy. Trial registration China Registered Clinical Trial Registration Center ChiCTR2000036515 . Registered on 13 November 2020.

Background Cervical radiculopathy (CR) is a common condition, often associated with cervicogenic headache (CGH), a secondary headache arising from cervical spine disorders. Mechanical intermittent cervical traction (MICT) is frequently prescribed to treat CR symptoms. The purpose of the study was to make a preliminary estimate of efficacy of adding MICT to conventional rehabilitation on CGH in patients with cervical radiculopathy. Methods A total of 36 CR patients with CGH were randomly allocated to 3 equally sized groups (A, B and C). The treatment consisted of twelve sessions of conventional rehabilitation (4 weeks) combined with MICT (2 kg for group A, 8 kg for group B and 12 kg for group C). Primary outcomes were CGH intensity (visual analog scale) and frequency (days per week). Secondary outcomes were radicular pain intensity (visual analog scale), cervical range of motion (cervical range of motion instrument), proprioception (cervical range of motion instrument) and muscle strength (MicroFET2 dynamometer), handgrip strength (handheld dynamometer), function (Neck Disability Index), kinesiophobia (Tampa Scale for KInesiophobia), anxiety and depression (Hospital Anxiety and Depresion questionnaire), and quality of life (World Health Organization Quality of Life). Patients were assessed at baseline, one, three and six months after the beginning of treatment. The post hoc Dunn testing was used to determine which traction load had the better effect on CGH symptoms. Results At one, three and six months follow-ups, Group C exhibited the highest improvement in CGH intensity and frequency compared to the other groups ( p  = 0.021 and p  = 0.023; p  = 0.012 and p  = 0.01; p  = 0.005 and p  = 0.005). Both groups C and B showed a significant improvement in radicular pain compared to group A at one month follow-up ( p  = 0.05).The improvement in group C was significantly better in terms of function ( p  = 0.049) and anxiety ( p  = 0.011) at three months and quality of life at six months (Psychological p  = 0.046 and Environment p  = 0.006). Conclusions The blend of conventional rehabilitation alongside 12 kg MICT seems to be efficacious in diminishing both the intensity and frequency of CGH in patients with CR. These advantages appear to last for up to six months following the treatment period, potentially leading to decreased CGH severity and occurrence rates, heightened functionality, reduced anxiety levels, and an overall enhancement in quality of life. These findings are preliminary and require confirmation in larger trials. Trial registration The study protocol was retrospectively registered at the Pan African Clinical Trial Registry (PACTR202401838955948). Date of registration is 16/01/2024.