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AbstractObjectiveTo assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes).DesignDouble blind, parallel group, placebo controlled, multicentre trial.SettingHospital outpatient clinics at six hospitals in Norway.Participants180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017.InterventionsPatients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription.Main outcome measuresThe primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4.ResultsIn the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was −1.6 (95% confidence interval −3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was −2.3 (−4.2 to−0.4, P=0.02) for patients with type 1 Modic changes and −0.1 (−2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group.ConclusionsIn this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes.Trial registrationClinicalTrials.gov NCT02323412.

Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control). 1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406. 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06–2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25–1·86]), equating to effect sizes of 0·32 (0·19–0·45) and 0·19 (0·04–0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group. The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care. Arthritis Research UK.

BACKGROUND AND OBJECTIVESThis study is a meta-analysis of randomized controlled trials comparing the efficacy of transcutaneous electrical nerve stimulation (TENS) to a control and to other nerve stimulation therapies (NSTs) for the treatment of chronic back pain. METHODSCitations were identified in MEDLINE, the Cochrane Library, Google Scholar, and ClinicalTrials.gov through June 2014 using the following keywordsnerve stimulation therapy, transcutaneous electrical nerve stimulation, back pain, chronic pain. Control treatments included sham, placebo, or medication only. Other NSTs included electroacupuncture, percutaneous electrical nerve stimulation, and percutaneous neuromodulation therapy. RESULTSTwelve randomized controlled trials including 700 patients were included in the analysis. The efficacy of TENS was similar to that of control treatment for providing pain relief (standardized difference in means [SDM] = −0.20; 95% confidence interval [CI], −0.58 to 0.18; P = 0.293). Other types of NSTs were more effective than TENS in providing pain relief (SDM = 0.86; 95% CI, 0.15–1.57; P = 0.017). Transcutaneous electrical nerve stimulation was more effective than control treatment in improving functional disability only in patients with follow-up of less than 6 weeks (SDM = −1.24; 95% CI, −1.83 to −0.65; P < 0.001). There was no difference in functional disability outcomes between TENS and other NSTs. CONCLUSIONSThese results suggest that TENS does not improve symptoms of lower back pain, but may offer short-term improvement of functional disability.

Objective. To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). Design. 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). Setting. Outpatient. Subjects. Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. Methods. The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). Results. Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen’s d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. Conclusions. Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP.

Background Patients with chronic low back pain (CLBP) usually demonstrate poor postural control due to impaired core muscle function. Dynamic neuromuscular stabilization (DNS) is based on developmental kinesiology principles, utilizing infant motor patterns to treat motor disorders. DNS has been shown to improve postural control in cerebral palsy patients by activating core muscle. However, whether the DNS approach is superior for enhancing core muscle contractility and postural control in CLBP patients still remains unclear. Objectives This study aimed to compare the effects of DNS training and conventional core exercises on core muscle contractility and standing postural control in CLBP patients. Methods Sixty CLBP patients were randomly assigned to a DNS group or a control group. Participants in the DNS group received DNS training, while those in the control group completed conventional core exercises. Both groups completed 12 sessions over 4 weeks (3 sessions/week, 50 min/session). Pre- and post-intervention evaluations included diagnostic musculoskeletal ultrasound to assess the change rate of core muscles (transversus abdominis (TrA), lumbar multifidus, and diaphragm), a balance assessment system to evaluate postural control performance (center of pressure displacement (COP)), and clinical questionnaires (Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Roland-Morris Disability Questionnaire (RDQ)) for pain intensity and disability. Results After 4 weeks, comparisons between both groups revealed significant statistical differences in the interaction effects of time*group. These differences were observed in the change rates of the left and right TrA (F 1,58 =4.820 and 3.964, p  = 0.032 and 0.041), diaphragm change rate (F 1,58 =11.945, p  = 0.001), as well as COP velocity (F 1,58 =5.283, p  = 0.025), variability (F 1,58 =13.189, p  = 0.001) in the anterior-posterior (AP) direction, COP path length (F 1,58 =6.395, p  = 0.014), and COP area (F 1,58 =5.038, p  = 0.029) in the eye-closed condition. DNS participants showed significantly greater muscle change rates and reduced COP ( p  < 0.05). The scores of VAS (F 1,58 =173.929, p  = 0.001), ODI (F 1,58 =60.871, p  = 0.001), and RDQ (F 1,58 =60.015, p  = 0.001) decreased significantly over time, although no group differences were found between both groups ( p  > 0.05). Conclusions DNS is superior to conventional core exercises in enhancing core muscle contractility and standing postural control in CLBP patients, showing potential to reduce pain and improve disability. Its mechanism may involve the enhancement of proprioceptive feedback, particularly when visual feedback is blocked. Trial registration This study was registered in the Chinese Clinical Trial Registry (ChiCTR) with the registration number ChiCTR2300074595 on 10 August 2023.

Background Multidisciplinary programs are the first recommendation for non-specific chronic low-back pain, but implementing this type of program is complicated to get up and running. The primary aim of this study was to assess the feasibility and appropriateness of the PAINDOC multidisciplinary program for subjects with chronic low-back pain. The secondary objectives were to evaluate the decrease in pain intensity, pain-related disability and pain catastrophizing, as well as the improvement in quality of life with this program. Furthermore, another of the secondary objectives was to calculate the sample size for a future randomized clinical trial. Methods This study was conducted in a hospital pain unit using two successive recruitment waves. First, the feasibility outcomes (recruitment, completion, and drop-out rates) of a 5-month non-random prospective cohort ( n  = 227) were recorded. Then, the clinical outcomes (pain intensity, quality of life, disability, and pain catastrophizing) were recorded from a prospective, controlled, two-armed and single-blind feasibility study (ClinicalTrials.gov, NCT05974072). It included 41 participants that were randomly allocated to either the pharmacological treatment ( n  = 21) arm or PAINDOC program ( n  = 20) arm. Results The recruitment rate was 66%, with the completion rate standing at 80.7% and the drop-out rate at 19.3%. Significant differences and a medium size effect were observed between groups in terms of pain intensity ( p  = .017, r  = .408) at the 4-month follow-up. The intragroup analysis of the PAINDOC group revealed significant lessening in pain intensity ( p  = < 0.001) and improvements in quality of life ( p  = .030). Conclusions This study showed that the PAINDOC multidisciplinary program is a feasible treatment for patients with non-specific chronic low-back pain. Furthermore, the exploratory results of this study suggest that it could be an effective treatment to reduce pain intensity and improve on self-reported quality of life in these patients, although a future randomized clinical trial is needed to determine its effectiveness. Trial registration NCT05974072 (registration date July 11, 2023; retrospectively registered; ClinicalTrials.gov).

BackgroundThe McKenzie Method of Mechanical Diagnosis and Therapy (MDT) is one of the exercise approaches recommended by low back pain (LBP) guidelines. We investigated the efficacy of MDT compared with placebo in patients with chronic LBP.MethodsThis was a prospectively registered, two-arm randomised placebo controlled trial, with a blinded assessor. A total of 148 patients seeking care for chronic LBP were randomly allocated to either MDT (n=74) or placebo (n=74). Patients from both groups received 10 treatment sessions over 5 weeks. Patients from both groups also received an educational booklet. Clinical outcomes were obtained at the end of treatment (5 weeks) and 3, 6 and 12 months after randomisation. Primary outcomes were pain intensity and disability at the end of treatment (5 weeks). We also conducted a subgroup analysis to identify potential treatment effect modifiers that could predict a better response to MDT treatment.ResultsThe MDT group had greater improvements in pain intensity at the end of treatment (mean difference (MD) −1.00, 95% CI −2.09 to −0.01) but not for disability (MD −0.84, 95% CI −2.62 to 0.93). We did not detect between-group differences for any secondary outcomes, nor were any treatment effect modifiers identified. Patients did not report any adverse events.ConclusionWe found a small and likely not clinically relevant difference in pain intensity favouring the MDT method immediately at the end of 5 weeks of treatment but not for disability. No other difference was found for any of the primary or secondary outcomes at any follow-up times.Trial registration numberClinicalTrials.gov (NCT02123394)

IntroductionLow back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectiveness studies.MethodsIn this randomized, multicenter comparative effectiveness study, 210 patients with clinically suspected sacroiliac joint pain who obtained short-term benefit from diagnostic sacroiliac joint injections and prognostic lateral branch blocks were randomly assigned to receive cooled radiofrequency ablation of the L5 dorsal ramus and S1–S3 lateral branches or standard medical management consisting of pharmacotherapy, injections and integrative therapies. The primary outcome measure was mean reduction in low back pain score on a 0–10 Numeric Rating Scale at 3 months. Secondary outcomes included measures of quality of life and function.Results3 months post-treatment, the mean Numeric Rating Scale pain score for the cooled radiofrequency ablation group was 3.8±2.4 (mean reduction 2.5±2.5) compared with 5.9±1.7 (mean reduction 0.4±1.7) in the standard medical management group (p<0.0001). 52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard medical management patients (p<0.0001). Comparable improvements favoring cooled radiofrequency ablation were noted in Oswestry Disability Index score (mean 29.7±15.2 vs 41.5+13.6; p<0.0001) and quality of life (mean EuroQoL-5 score 0.68±0.22 vs 0.47±0.29; p<0.0001).ConclusionsIn patients with sacroiliac joint pain, cooled radiofrequency ablation provided statistically superior improvements across the spectrum of patient outcomes compared with standard medical management.Trial registration number NCT03601949.

Background As a leading cause of disability, chronic low back pain (CLBP) is a musculoskeletal condition often associated with impaired physical and cognitive functions. Due to its multi-factorial facets, the application of multimodal interventions is recommended. MultiMove is a multimodal intervention designed for CLBP patients, which combines motor-cognitive and dancing exercises. This study aimed to assess the effects of an additional MultiMove intervention to a standard inpatient rehabilitation on clinical and functional outcomes in CLBP patients. Methods For this prospective, two-arm, controlled pilot trial, 27 CLBP patients (17 females, 10 males) undergoing a 3-week inpatient rehabilitation, in a rehabilitation clinic in Germany, were recruited. The intervention group (IG, n  = 15, 61.6 ± 1.8 years) received a daily MultiMove session in addition to the standard rehabilitation, while the control group (CG, n  = 12, 63.8 ± 2.2 years) followed the standard rehabilitation. Physical (Timed Up and Go (TUG) [primary outcome], Five-Repetition Sit-to-Stand (FRSTS), and Six-Minute Walk Test (6MWT), trunk range of motion, single and dual task walking)), clinical (acute/chronic pain intensity, Oswestry Disability Index, EQ-5D-5 L), cognitive (Stroop Color Word Test, Trail Making Test), and psychosocial outcomes (Tampa Scale of Kinesiophobia, Beck Depression Inventory-II, Coping Strategies Questionnaire) were assessed during the first (pre-test) and last day (post-test) of the inpatient rehabilitation. Results The statistical analyses revealed improvements in trunk range of motion (sagittal plane: p  = 0.018, d  = 1.00; transversal plane: p  = 0.006, d  = 1.18) and 6MWT performance ( p  = 0.003, d  = 1.30) in the IG compared to the CG. Moreover, lower dual task costs for a gait variability measure ( p  = 0.034, d  = 0.97) as well as reduced chronic pain intensity ( p  = 0.004, d  = 1.33), kinesiophobia ( p  = 0.035, d  = 1.15), and depression ( p  = 0.034, d  = 1.08) were found in favour of the IG. Conclusion Data indicate that the multimodal intervention MultiMove improved clinical and functional outcomes in CLBP patients during inpatient rehabilitation. Therefore, conducting a randomized controlled trial with a large sample size is recommended to verify and extent these results. Trial registration MultiMove project (German Clinical Trial Register, ID: DRKS00021696 / 10.07.2020, https://drks.de/drks_web/navigate.do?navigationId=trial.HTML26TRIAL_ID=DRKS00021696 ) and was carried out in the rehabilitation clinic Bad Salzelmen (Schönebeck, Germany).

Background Low back pain (LBP) is a major global health issue, affecting approximately two-thirds of the population at some point in their lives. Modic changes (MCs) in the vertebral endplates, as observed on MRI, are recognized contributors to LBP and may be linked to advanced stages of intervertebral disc degeneration (IDD). Prior research has shown a decrease in the genus Bifidobacterium in the endplate cartilage of patients with IDD and concurrent MCs. The potential link between reduced Bifidobacterium levels and MC-related LBP remains unclear. Methods This multicenter, double-blinded, randomized, placebo-controlled trial will be conducted at four hospitals in China, comparing the efficacy of orally administered Bifidobacterium adolescentis (BA) with that of a placebo. Participants will receive the treatment twice daily for a duration of three months. The study targets patients with chronic low back pain (LBP) and Modic type I or II. Eligible patients will be randomly assigned to receive either Bifidobacterium adolescentis or a placebo for three months. The primary outcome will be the change in the Simplified Chinese Roland-Morris Disability Questionnaire (SCRMDQ) score at 3, 6, and 12 months post-treatment. Secondary outcomes include changes in DASS-21 scores, MRI imaging, bone density measurements, and serum biomarker analysis. Discussion This study will provide valuable insights into the therapeutic potential of Bifidobacterium adolescentis in managing chronic LBP associated with Modic changes, potentially offering a novel approach to treating this common and debilitating condition. Trial registration The trial has been registered with China Clinical Trial Registry, under the registration number ChiCTR2400088577. Registered on 21 August. The study was prospectively registered.