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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

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.

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.

Chronic low back pain (CLBP) is linked to reduced excitability in the primary motor (M1) and sensory (S1) cortices. Combining sensory-motor exercises with transcranial direct current stimulation (tDCS) to boost M1 and S1 excitability may improve treatment outcomes. This combined approach aligns with the neurophysiological mechanisms underlying CLBP and may target the neuroplastic changes induced by low back pain. This study aimed to assess whether enhancing M1 and S1 excitability via tDCS, alongside sensory-motor exercises, offers additional benefits for CLBP patients. Participants were randomly assigned to receive either real or sham tDCS alongside sensory-motor exercises. Outcome measures included pain intensity, disability level, motor control ability, amplitudes of N80 and N150, and the amplitude of motor-evoked potential (MEP) and active motor threshold (AMT) for the multifidus (MF) and transversus abdominis/internal oblique (TrA/IO) muscles. A linear mixed-effects model (LMM) analyzed group, time, and interaction effects, while Spearman's correlation assessed relationships between neurophysiological and clinical outcomes. The results showed significant reductions in pain intensity and disability levels (P < 0.001) and improved motor control (P < 0.001) in both groups. Both groups also exhibited increase in MF MEP amplitude (P = 0.042) and N150 amplitude (P = 0.028). The tDCS group demonstrated a significant decrease in AMT of MF and TrA/IO muscles (P < 0.05) and an increase in N80 amplitude (P = 0.027), with no significant changes in the control group. Additionally, the tDCS group had significantly lower AMT for the TrA/IO muscle in the post-test compared to the sham group (P = 0.001). Increased N150 amplitude was correlated with improved motor control. The findings showed that sensory-motor exercises combined with either tDCS or sham tDCS effectively reduced pain intensity, decreased disability, and improved lumbar motor control in lumbosacral radiculopathy patients. No significant differences were observed between groups, indicating no added clinical benefit from tDCS over exercises alone. However, both groups demonstrated increased N150 and MF MEP amplitudes, suggesting enhanced cortical excitability in motor and sensory regions. While clinical outcomes were similar, neurophysiological data indicate that sensory-motor exercises play a central role in boosting cortical excitability, with tDCS further amplifying this effect, as evidenced by a significant AMT reduction in MF and TrA/IO muscles and an increase in N80 amplitude.

Isolated lumbar extension resistance exercise (ILEX) has been shown to effectively address chronic low back pain (LBP) and paraspinal deconditioning. However, its role within the widely recommended multimodal management approaches remains unclear. This study aimed to: (1) closely monitor the effects of ILEX throughout the course of a 16-weeks intervention, applied as a stand-alone approach in patients with nociceptive and/or neuropathic pain and (2) to compare this intervention with a multimodal treatment program including general exercise (GE) and manual therapy (MT). Fifty-eight LBP patients were enrolled in this single-center (Wuerzburg, Germany), prospective, non-randomized controlled trial. The ILEX-only group ( Powerspine Back [ PSB] : n = 29) completed 25 sessions of ILEX, whereas the integrative group ( PSB + : n = 29) also received GE (added to each session) and MT (5 to 7 sessions). Outcome measures were assessed at baseline, 3, 6, 9 and 16 weeks including lumbar multifidus cross-sectional area (CSA), muscle thickness (MT), echointensity (EI) (ultrasound-derived), isometric lumbar strength (isokinetic device) and validated questionnaires (Visual Analog Scale [VAS]; Oswestry Disability Index [ODI]; Short-Form 36). Between-subjects repeated measures ANOVA and correlation analyses were performed. Both groups (PSB: m = 16, f = 15, Ø40.26 (± 13.71) years, BMI 25.16 (± 4.07) kg/m 2 ; PSB+ : m = 16, f = 13, Ø42.00 (± 12.69) years, BMI 25.20 (± 3.29) kg/m 2 ) demonstrated comparable linear improvements in multifidus CSA (PSB: Δ0.59 [95% CI 0.36–0.82] cm 2 ; PSB+ : Δ0.72 [95% CI 0.49–0.96] cm 2 , both p  < 0.001; main effect (group): p  = 0.52) along with similar strength gains (PSB: Δ96.79 [95% CI 57.64–135.93] Nm; PSB+ : Δ86.88 [95% CI 48.70–125.06] Nm; both p  < 0.001; main effect (group): p  = 0.91) over time. EI remained unchanged in both groups. No-between group differences were observed for self-reported measures, while all outcomes significantly improved (ODI: PSB: − 15.0 [95% CI − 19.3 to − 10.8], PSB+ : − 11.7 [95% CI − 16.0 to − 7.4]; VAS: PSB: − 29.30 [95% CI − 37.73 to − 20.86], PSB+ : − 29.34 [95% CI − 37.78 to − 20.91], both p  < 0.001). Only PSB+ showed correlations between multifidus changes and clinical outcomes. Stand-alone and combined isolated lumbar extension resistance exercise interventions are effective in reversing muscle deconditioning and produce comparable clinical outcomes. The results inform clinical decision-making and support the development of targeted, resource-efficient rehabilitation strategies. ClinicalTrials.gov Identifier NCT06890052 (20/03/2025) ( https://clinicaltrials.gov/study/NCT06890052?cond=NCT06890052%20&rank=1 )

The objective of the study was to compare the effectiveness of neural mobilization technique with conservative treatment on pain intensity, cervical range of motion, and disability. It was a randomized clinical trial; data was collected from Mayo Hospital, Lahore. Eighty-eight patients fulfilling the sample selection criteria were randomly assigned into group 1 (neural mobilization) and group 2 (conventional treatment). Pain intensity was measured on a numeric pain rating scale, range of motion with an inclinometer, and functional status with neck disability index (NDI). Data were analyzed using SPSS, repeated measure ANOVA for cervical ranges and the Friedman test for NPRS and NDI were used for within-group analysis. Independent samples t-test for cervical ranges and Mann-Whitney U test for NPRS and NDI were used for between-group comparisons. There was a significant improvement in pain, disability, and cervical range of motion after the treatment in both groups compared to the pre-treatment status (p < 0.001), and when both groups were compared neural mobilization was more effective than conventional treatment in reducing pain and neck disability (p < 0.001), but there was no significant difference present in the mean score of cervical range of motion between both groups. (p>0.05). The present study concluded that both neural mobilization and conservative treatment were effective as an exercise program for patients with cervical radiculopathy, however, neural mobilization was more effective in reducing pain and neck disability in cervical radiculopathy. RCT20190325043109N1.

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.

Background Cervical radiculopathy is usually caused by disc herniation or spondylosis. The prognosis is expected to be good in most patients, but there is limited scientific evidence on the indications for nonsurgical and surgical treatments. The aim of the present study is to evaluate and compare the effectiveness of surgical and nonsurgical treatment in two trials – including disc herniation and spondylosis, respectively, and to evaluate factors that contribute to better decision making. Methods/design Patients with disabling radicular arm pain and MRI-proven cervical disc herniation or spondylosis will be randomised to receive nonsurgical or surgical treatment. The follow-up period is one year and the sample size is estimated to be 50 for each arm in the two trials, giving a total of 200 patients. The primary outcomes are the Neck Disability Index and arm pain. Secondary outcomes include neck pain; EQ-5D and costs to evaluate cost-effectiveness; prognostic factors; CT and MRI scans, to estimate intervertebral foraminal area and nerve root compression; and the expected minimal improvement for willingness to undergo treatment. Discussion The outcomes of this study will contribute to better decision making in the treatment of cervical radiculopathy. Trial registration This study has been registered at ClinicalTrials.gov as NCT03674619 , on September 17, 2018.

Objectives: To observe the clinical efficacy of Tiaokou acupoint‐penetrating Chengshan combined with conventional therapy for C5 nerve root palsy after posterior cervical decompression surgery. Methods: A total of 52 patients undergoing posterior cervical decompression surgery at Tianjin Union Medical Center from March 2020 to March 2023 were grouped using computer‐generated random numbers. Group A ( n  = 26) received the treatment of acupuncture combined with conventional therapy. Group B ( n  = 26) received only conventional therapy. Results: The VAS scores of the two groups after treatment were significantly lower than scores before treatment ( p < 0.01). The JOA scores, Lovett muscle strength grade, and shoulder ROM of the two groups after treatment were significantly higher than those before treatment ( p < 0.01). After treatment, the VAS scores of Group A were significantly lower than those in Group B ( p < 0.01) while the JOA scores, Lovett muscle strength grade, and shoulder ROM were significantly higher than those in Group B ( p < 0.01). There were significant differences in VAS difference ( p < 0.01) and JOA difference ( p < 0.01) after 2 weeks of intervention treatment in Group A compared to Group B. There was a significant difference in the improvement of shoulder ROM in Group A after 2 weeks of intervention compared to Group B. Conclusions: The acupuncture method of Tiaokou acupoint‐penetrating Chengshan combined with conventional nutritional support therapy was more effective in patients with C5 nerve root palsy after posterior cervical decompression surgery compared to conventional nutritional support therapy. Trial Registration: Clinical Trial Registry identifier: ChiCTR2300073583

BACKGROUND: Lumbar radicular pain (LRP) is a common but challenging clinical symptom. Pulsed radiofrequency (PRF), a neuromodulation technique that uses short pulses of radiofrequency current, is effective in treating various pain disorders. However, few studies have been conducted on the effects of PRF and its modifying parameters. OBJECTIVES: Our study aimed to determine the intraoperative parameters of PRF of the lumbar dorsal root ganglion (DRG) that are related to clinical effects in patients with LRP unresponsive to transforaminal epidural steroid injections (TFESI). STUDY DESIGN: Prospective double-blind randomized controlled trial, pilot study. SETTING: Single medical center in the Republic of Korea. METHODS: Patients were allocated to one of 2 groups, high-voltage (60 V) or standard-voltage (45 V), according to the preset maximum voltage at which the active tip temperature does not exceed 42°C. Intraoperative parameters, such as output current, sensory threshold, and impedance, were measured. The primary outcomes were radicular pain intensity, physical functioning, global improvement and satisfaction with treatment, and adverse events. The assessments were performed up to 3 months postprocedure. RESULTS: The patients in the standard-voltage group showed significant improvements in the Numeric Rating Scale pain score (P = 0.007) and Oswestry Disability Index (ODI) (P = 0.008) scores at 3 months post-PRF; however, no difference was observed in the high-voltage group. Among the intraoperative parameters, the output current showed a significant negative linear relationship with analgesic efficacy. The output current also showed a significant association with pain intensity (P = 0.005, R2 = 0.422) and ODI score (P = 0.004, R2 = 0.427) at 3 months postprocedure in a multiple regression analysis. The optimal cut-off value of the output current to lower pain intensity after 3 months was 163.5 mA with a sensitivity of 87.5%, specificity of 100%, and an area under the receiver operating characteristic curve value of 0.92 (95% CI. 0.76 – 1.00). LIMITATIONS: Limitations of our study include an imbalance of baseline characteristics, small sample sizes, and short follow-up periods CONCLUSIONS: Lower output currents during PRF application to the lumbar DRG were associated with greater analgesic effects in patients who did not respond to therapeutic TFESI. KEY WORDS: Lumbar radicular pain, pulsed radiofrequency, dorsal root ganglion