Mean Roland-Morris Disability Questionnaire Score Research Articles

An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry

PurposeTo evaluate the efficacy of sacroplasty for treating sacral insufficiency fractures, including the effect on pain relief, patient function and adverse event rates in an as-treated on-label prospective data registry. Materials and MethodsObservational data including patient reported outcomes (PROs), patient characteristics, osteoporosis treatment, fracture duration, cause of sacral fractures and image guidance used for treatment were collected for patients undergoing sacroplasty. The PROs were collected at baseline then at one, three, and at six months following the procedure. The primary outcomes were pain as measured by the Numerical Rating Scale (NRS) and function as measured by the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included adverse events, cement leakage, new neurologic events, readmissions and death. ResultsThe interim results for the first 102 patients included significant pain reduction with mean pain improvement scores at six months decreasing from 7.8 to 0.9 (P < .001) and significant improvement in function with mean RMDQ scores improving from 17.7 to 5.2 (P < .001). Most procedures were performed under fluoroscopy (58%). There was cement leakage in 17.7% of the subjects but only one adverse event which was a new neurologic deficit related to cement extravasation. The readmission rate was 16% mostly due to additional back pain and fractures and there were no subject deaths. ConclusionsSacroplasty with cement augmentation for acute, subacute and chronic painful sacral insufficiency fractures caused by osteoporosis or neoplastic disorders results in highly significant improvements in pain and function with very low rate of procedural related adverse events.

Back Pain According to Roland-Morris Low Back Pain Scale After Abdominoplasty With Plication: A Prospective Case Series.

Chronic back pain is a physically debilitating condition that affects more than 80% of adults in the United States. A recent case series highlighted how abdominoplasty with plication can offer an alternative surgical approach for treating chronic back pain. These results have been corroborated by a large prospective series. However, this study excluded male and nulliparous subjects, who may also benefit from this surgery. Our group aims to investigate the effect of abdominoplasty on back pain in a more diverse patient population. Subjects older than 18 years undergoing abdominoplasty with plication were recruited. An initial survey called the Roland-Morris Disability Questionnaire (RMQ) was administered at the preoperative visit. This questionnaire inquiries about and grades the patient's history of back pain and surgery. Demographic, medical, and social history was also obtained. A follow-up survey and RMQ was then given 6 months after surgery. Thirty subjects were enrolled. Subjects had a mean age of 43.4 ± 14.3 years. Twenty-eight subjects were female and 26 were postpartum. Twenty-one subjects reported initial back pain on the RMQ scale. Of these, 19 reported a decrease in RMQ score after surgery, including male and nulliparous subjects. A significant decrease in mean RMQ score was demonstrated 6 months after surgery (2.94-0.44, P < 0.001). Further subgroup analysis of female subjects demonstrated significantly decreased final RMQ score in parous women, vaginal or cesarean section delivery, and absence of twin gestation. Abdominoplasty with plication significantly decreases self-reported back pain 6 months after surgery. These results support that abdominoplasty is not purely a cosmetic procedure but can also be applied therapeutically to improve functional symptoms of back pain.

Co-existence of Lumbar Disc Herniation and Posterior Ring Apophyseal Fracture: It Is Not Rare and Computed Tomography Is Useful.

Introduction Posterior ring apophyseal fracture (PRAF) is characterized by the separation of bone fragments and sometimes coexists with lumbar disc herniation (LDH). However, how often these conditions coexist and the details of the clinical course remain unclear. Methods We analyzed 200 patients who underwent surgical treatment for LDH at our hospital from January 2016 to December 2020. Among these, we reviewed 21 patients who underwent microendoscopic surgery to treat PRAF. They consisted of 11 male and 10 female patients, ranging in age from 15 to 63 years. The average age was 32.8 months, and the average follow-up period was 39.8 years. We performed simple roentgenography and magnetic resonance imaging for all patients and computed tomography for about 80% of the patients. We evaluated the type of PRAF fragment (Takata classification), disease level, Japanese Orthopedic Association (JOA) score, Roland-Morris Disability Questionnaire (RDQ) score, operating time, intraoperative blood loss, and perioperative complications. Results A total of 10.5% of patients with LDH also had PRAF. The mean JOA score significantly improved from 10.6 ± 5.7 points before surgery to 21.4 ± 5.1 points at the final observation (p < 0.05). The mean RDQ score significantly improved from 17.1 ± 4.5 preoperatively to 5.5 ± 0.5 at the final observation (p < 0.05). The average operation time was 88.6 minutes. There were no complications requiring early surgery that were due to postoperative infection or epidural hematoma, but one patient required reoperation. Conclusion This study showed that PRAF coexisted with LDH in about 10% of cases, and the outcomes of surgical treatment were generally good. Computed tomography is recommended to improve the diagnostic rate and assist with surgical planning and intraoperative decision-making.

Psychophysiologic symptom relief therapy for chronic back pain: a pilot randomized controlled trial.

Chronic back pain is the leading cause of disability in the United States. Based on the hypothesis that nonspecific back pain may be rooted in a psychophysiologic etiology, we propose a new approach to chronic back pain. A pilot study was conducted to assess whether psychophysiologic symptom relief therapy (PSRT) can reduce disability and back pain bothersomeness for patients with chronic back pain. This was a three-armed, randomized trial for adults with nonspecific chronic back pain that compared PSRT with usual care and an active comparator (mindfulness-based stress reduction [MBSR]). Psychophysiologic symptom relief therapy-randomized participants received a 12-week (36 hours) course based on the psychophysiological model of pain. All groups were administered validated questionnaires at baseline and at 4, 8, 13, and 26 weeks. The primary outcome was the reduction in pain disability measured by the Roland-Morris Disability Questionnaire. The mean Roland-Morris Disability Questionnaire score for the PSRT group (n = 11) decreased from 9.5 (±4.3 SDs) to 3.3 (±5.1) after 26 weeks which was statistically significant compared with both MBSR (n = 12) (P = 0.04) and usual care (n = 12) (P = 0.03). Pain bothersomeness scores and pain-related anxiety decreased significantly over 26 weeks in PSRT compared with MBSR and usual care (data in manuscript). At 26 weeks, 63.6% of the PSRT arm reported being pain free (0/10 pain) compared with 25.0% and 16.7% in MBSR and usual care arms, respectively. Psychophysiologic symptom relief therapy attendance was 76%, and there was 100% follow-up of all groups. Psychophysiologic symptom relief therapy is a feasible and potentially highly beneficial treatment for patients with nonspecific back pain.

Using percutaneous parapedicle screw vertebroplasty to treat transpedicle screw loosening.

Pedicle screw loosening (PSL) is a postsurgical complication of spinal fusion surgery that can result in morbidity. The aim of this study was to evaluate the efficacy and safety of percutaneous parapedicle screw vertebroplasty (PPSV) for pain reduction and motility improvement in patients with PSL. The postsurgical solid inter-body fusion with inter-body bone mass formation of 32 patients who underwent lumbar-sacrum spinal fusion surgery was confirmed with plain films and CT scans. Each patient had one or two screws with symptomatic PSL and was treated with PPSV. All the patients were then followed up for 12 to 24 months. The visual analog scale (VAS) and Roland-Morris Disability Questionnaire (RMDQ) were used to evaluate each patient before the operation, after the operation, and during the follow-up period. A total of 32 patients with a total of 47 screws with PSL were treated with PPSV and experienced different results in terms of pain reduction (with the mean VAS score dropping from 7.97 ± 0.74 to 2.34 ± 1.59, p < 0.001) and motility improvement (with the mean RMDQ score dropping from 16.75 ± 1.84 to 7.21 ± 4.08, p < 0.001). The motility improvement was significantly correlated with pain reduction (r = 0.42, p = 0.018), with the mean follow-up period being 19.3 ± 6.2 months (range: 8-36 months). However, five patients who experienced moderate improvements had eventually received a revision operation after undergoing PPSV. The PPSV procedure is effective and safe for the reduction of pain and improvement of life quality in patients with PSL. It can thus be considered as a possible option for the revision of spinal fusion surgery.

Single vertebral manipulative therapy (Kitchener’s Technique): a new technique for treatment of acute and subacute spinal root compression

Introduction: Spinal Root Compression Syndromes (SRCS) are common, costly, and significant cause of long-term sick leave and work loss. There is No consensus on the best approach. One intervention often used is manipulative therapy. Objective: The aim of this study was to determine if Single Vertebral Manipulative Therapy (Kitchener’s Technique) (SVMT) is effective in alleviating pain levels and regaining physical functioning in comparison to standard medical care (SMC), among 18-55-year-old active working personnel. Methods: Prospective, longitudinal, 2-arm controlled study comparing SMC plus SVMT (32 patients) with only SMC (21 patients). The primary outcome measures were changes in root-related pain on the numerical rating scale and physical functioning at 6 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). Results: Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus SVMT group than in the SMC group at both week 2 (P&lt;0.001) and week 6 (P=0.001). Mean numerical rating scale pain scores were also significantly better in the group that received SVMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus SVMT group than in the SMC group at both week 2 (P&lt;0.001) and week 6 (P=0.001). Conclusion: Results suggest that SVMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only SMC, for patients aged 18-55 years with SRCS.

CORRELATION BETWEEN CHRONIC LOW BACK PAIN AND FEMALE SEXUAL FUNCTION

ABSTRACT Objective To correlate chronic low back pain with female sexual function. Methods This is a cross-sectional study. Thirty-two women aged between 18 and 44 years old, with body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2, with a medical diagnosis of chronic low back pain and sexually active in the last six months were selected. The patients underwent a physical therapy evaluation and responded to two questionnaires: the Roland-Morris Disability Questionnaire and the Female Sexual Quotient (QS-F). Pearson’s correlation test was used to assess the impact of chronic low back pain on sexual activity. Results The mean age was 30.31 years old (±.7.10) and the mean BMI was 24.54 Kg/m2 (±3.06). The mean Roland-Morris Disability Questionnaire score was 5.2 ( ± 3.28), indicating that the patients did not have significant disability. The mean QS-F score was 60.37 (±14.48), classified as “unfavorable to normal”. The correlation test showed a low correlation between chronic low back pain and female sexual function (r = 0.027). Conclusion There was a low correlation between chronic low back pain and female sexual function in the study population, but the moderate correlation between the “comfort” domain and the Roland-Morris Disability Questionnaire score was significant. Level of evidence II ; Cross-sectional clinical study.

Oedema on STIR modified the effect of amoxicillin as treatment for chronic low back pain with Modic changes\u2014subgroup analysis of a randomized trial

ObjectiveTo evaluate potential MRI-defined effect modifiers of amoxicillin treatment in patients with chronic low back pain and type 1 or 2 Modic changes (MCs) at the level of a previous lumbar disc herniation (index level).MethodsIn a prospective trial (AIM), 180 patients (25–64 years; mean age 45; 105 women) were randomised to receive amoxicillin or placebo for 3 months. Primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (0–24 scale) at 1 year. Mean RMDQ score difference between the groups at 1 year defined the treatment effect; 4 RMDQ points defined the minimal clinically important effect. Predefined baseline MRI features of MCs at the index level(s) were investigated as potential effect modifiers. The predefined primary hypothesis was a better effect of amoxicillin when short tau inversion recovery (STIR) shows more MC-related high signal. To evaluate this hypothesis, we pre-constructed a composite variable with three categories (STIR1/2/3). STIR3 implied MC-related STIR signal increases with volume ≥ 25% and height > 50% of vertebral body and maximum intensity increase ≥ 25% and presence on both sides of the disc. As pre-planned, interaction with treatment was analysed using ANCOVA in the per protocol population (n = 155).ResultsThe STIR3 composite group (n = 41) and STIR signal volume ≥ 25% alone (n = 45) modified the treatment effect of amoxicillin. As hypothesised, STIR3 patients reported the largest effect (− 5.1 RMDQ points; 95% CI − 8.2 to − 1.9; p for interaction = 0.008).ConclusionsPredefined subgroups with abundant MC-related index-level oedema on STIR modified the effect of amoxicillin. This finding needs replication and further support.Key Points• In the primary analysis of the AIM trial, the effect of amoxicillin in patients with chronic low back pain and type 1 or 2 MCs did not reach the predefined cut-off for clinical importance.• In the present MRI subgroup analysis of AIM, predefined subgroups with abundant MC-related oedema on STIR reported an effect of amoxicillin.• This finding requires replication and further support.

Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain

Chronic low back pain has high societal and personal impact but remains challenging to treat. Electroacupuncture has demonstrated superior analgesia compared with placebo in animal studies but has not been extensively studied in human chronic pain conditions. To evaluate the treatment effect of real electroacupuncture vs placebo in pain and disability among adults with chronic low back pain and to explore psychophysical, affective, and demographic factors associated with response to electroacupuncture vs placebo in treating chronic low back pain. This double-blind randomized clinical trial was conducted between August 2, 2016, and December 18, 2018, at a single center in Stanford, California. Primary outcomes were collected at approximately 2 weeks before and after intervention. Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy. Data analyses for this intent-to-treat study were conducted from June 2019 to June 2020. Twelve sessions of real or placebo (sham) electroacupuncture administered twice a week over 6 weeks. The main outcome was change in pain severity from baseline to 2 weeks after completion of treatment, measured by the National Institutes of Health PROMIS pain intensity scale. A secondary outcome was change in the Roland Morris Disability Questionnaire (RMDQ). Baseline factors potentially associated with these outcomes included psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant's self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race). A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women) were randomized to real electroacupuncture and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women) were randomized to sham electroacupuncture. At baseline, the mean (SD) PROMIS T-score was 50.49 (3.36) in the real electroacupuncture group and 51.71 (4.70) in the sham acupuncture group, and the mean (SD) RMDQ score was 10.16 (4.76) in the real electroacupuncture group and 10.03 (5.45) in the sham acupuncture group. After adjusting for baseline pain scores, there was no statistically significant difference between groups in change in T-scores 2 weeks after completion of treatment (real electroacupuncture: -4.33; 95% CI, -6.36 to -2.30; sham acupuncture: -2.90; 95% CI, -4.85 to -0.95; difference: -2.09; 95% CI, -4.27 to 0.09; P = .06). After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01). Within the real electroacupuncture group, effective coping at baseline was associated with greater RMDQ reduction (r = -0.32; 95% CI, -0.54 to -0.05; P = .02), and White race was associated with worse outcomes in PROMIS score (β = 3.791; 95% CI, 0.616 to 6.965; P = .02) and RMDQ (β = 2.878; 95% CI, 0.506 to 5.250; P = .02). This randomized clinical trial found no statistically significant difference in change in PROMIS pain score in real electroacupuncture vs sham electroacupuncture. There was a statistically significant treatment effect for the secondary outcome of RMDQ compared with sham electroacupuncture. Effective coping skills and non-White race were associated with response to electroacupuncture. ClinicalTrials.gov Identifier: NCT02890810.

Appropriate Management of Vertebral Fragility Fractures: Development of a Pathway Based on a Vertebral Compression Fracture Registry

The BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments. The purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry. Prospective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure. The VCF Registry is a national ongoing registry with no specified end time or designated sample size. Primary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death. The VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation. The nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings. Cement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population. Vertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.

Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study)

BackgroundRandomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation.MethodsWe performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms.ResultsNone of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis).ConclusionsWe did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies.Trial registrationClinicalTrials.gov NCT02323412, First registered 23 December 2014.

The IMPACT study: A clustered randomized controlled trial to assess the effect of a referral algorithm for axial spondyloarthritis.

BackgroundA substantial number of patients with chronic low back pain (CLBP) have axial spondyloarthritis (axSpA), but early recognition of these patients is difficult for general practitioners (GPs). The Case Finding Axial Spondyloarthritis (CaFaSpA) referral strategy has shown to be able to identify patients with CLBP at risk for axSpA, but its impact on clinical daily practice is yet unknown.ObjectiveTo assess the effect of the CaFaSpA referral strategy on pain caused by disability in primary care patients with CLBP.MethodsWithin this clustered randomized controlled trial 93 general practices were randomized to either the CaFaSpA referral model (intervention) or usual primary care (control). In each group primary care patients between 18 and 45 years with CLBP were included. The primary outcome was disability caused by CLBP, measured with the Roland Morris Disability Questionnaire (RMDQ) at baseline and four months. Secondary outcome was the frequency of new axSpA diagnosis. Descriptive analyses were performed, and a linear mixed-effects model was used.ResultsIn total 679 CLBP patients were included of which 333 patients were allocated to the intervention group and 346 to the control group. Sixty-four percent were female and mean age was 36.2 years. The mean RMDQ score at baseline was 8.39 in the intervention group and 8.61 in the control group. At four months mean RMDQ score was 7.65 in the intervention group and 8.15 in the control group. This difference was not statistically significant (p = 0.50). Six (8%) out of the 75 finally referred patients, were diagnosed with axSpA by their rheumatologist.ConclusionsThe CaFaSpA referral strategy for axSpA did not have an effect on disability after four months caused by CLBP. However, the strategy is able to detect the axSpA patient within the large CLBP population sufficiently.Trial registration number: NCT01944163, Clinicaltrials.gov.

Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial

ObjectiveTo 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,...

The Fear Reduction Exercised Early (FREE) approach to management of low back pain in general practice: A pragmatic cluster-randomised controlled trial

BackgroundEffective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world’s most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control).Methods and findingsThis pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI −0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices.ConclusionsFindings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP.Trial registrationACTRN12616000888460

A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain

Patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and skeletal muscle relaxants. We compare functional outcomes and pain among patients with acute low back pain who were randomized to a 1-week course of ibuprofen plus placebo versus ibuprofen plus 1 of 3 skeletal muscle relaxants: baclofen, metaxalone, and tizanidine. This was a randomized, double-blind, parallel-group, 4-arm study conducted in 2 urban emergency departments (EDs). Patients with nonradicular low back pain for less than or equal to 2 weeks were eligible if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a 24-item inventory of functional impairment caused by low back pain. All participants received 21 tablets of ibuprofen 600 mg, to be taken 3 times a day as needed. Additionally, they were randomized to baclofen 10 mg, metaxalone 400 mg, tizanidine 2 mg, or placebo. Participants were instructed to take 1 or 2 of these capsules 3 times a day as needed. All participants received a 10-minute educational session. The primary outcome was improvement on the Roland-Morris Disability Questionnaire between ED discharge and 1week later. Secondary outcomes included pain intensity 1 week after ED discharge (severe, moderate, mild, or none). Three hundred twenty patients were randomized. One week later, the mean Roland-Morris Disability Questionnaire score of patients randomized to placebo improved by 11.1 points (95% confidence interval [CI] 9.0 to 13.3), baclofen by 10.6 points (95% CI 8.6 to 12.7), metaxalone by 10.1 points (95% CI 8.0 to 12.3), and tizanidine by 11.2 points (95% CI 9.2 to 13.2). At 1-week follow-up, 30% of placebo patients (95% CI 21% to 41%) reported moderate to severe low back pain versus 33% of baclofen patients (95% CI 24% to 44%), 37% of metaxalone patients (95% CI 27% to 48%), and 33% of tizanidine patients (95% CI 23% to 44%). Adding baclofen, metaxalone, or tizanidine to ibuprofen does not appear to improve functioning or pain any more than placebo plus ibuprofen by 1 week after an ED visit for acute low back pain.

Outcomes of direct lateral interbody fusion (DLIF) in an Australian cohort.

Direct lateral interbody fusion (DLIF) mitigates many of the vascular complications and bony resections associated with other interbody fusion techniques. However, there are concerns regarding postoperative neural complications and that indirect decompression of the foramen has not been consistently demonstrated. This study prospectively assessed the clinical and radiological outcomes and the complication rates of the DLIF approach. A prospective review was conducted of the first 50 consecutive DLIF cases of a single neurosurgeon between 2010 and 2014. Clinical outcomes were assessed using Visual Analogue Scale (VAS), Oswestry Disability Index (ODI) and Roland Morris Disability Questionnaire (RMDQ) surveys. Radiological outcomes, including spondylolisthesis, disc height, local disc angle, lumbar lordosis and foraminal height and width, were measured using Surgimap Spine software at the preoperative, 6 weeks, 6 months, and 12 months postoperative follow-up. Complication rates were also reported. A total of 50 patients (84 levels) were treated with DLIF. The mean patient age was 68.2±9.8 years and 62.0% were female. At latest follow-up, mean VAS pain score improved from 7.7±1.5 to 1.9±0.9 (P<0.0001), mean ODI improved from 42.1±14.5 to 16.9±6.7 (P<0.0001) and mean RMDQ score improved from 12.1±5.2 to 6.2±4.7 (P<0.0001). Mean spondylolisthesis reduced from 7.5%±6.5% to 1.3%±1.1% at 6 weeks (P<0.0001), 0.95%±0.74% at 6 months (P<0.0001) and recurred to 1.9%±1.7% at 12 months postoperatively (P=0.0006). Mean anterior disc height improved from 7.3±3.2 to 11.6±2.5 mm at 6 weeks (P<0.0001), 12.2±3.3 mm at 6 months (P<0.0001) and 9.8±2.1 mm at 12 months (P=0.0032) postoperatively. Mean posterior disc height improved from 4.4±2.0 to 6.8±2.1 mm at 6 weeks (P<0.0001), 6.6±2.5 mm at 6 months (P=0.0003), and 5.9±1.4 mm at 12 months (P=0.0039) postoperatively. Mean local disc angle improved from 7.0°±3.7° to 9.2°±3.3° at 6 weeks (P=0.0072), 10.4°±3.9° at 6 months (P=0.0013) and 8.2°±2.9° at 12 months (P=0.2487) postoperatively. No significant postoperative changes in lumbar lordosis were observed. Mean foraminal height improved from 18.3±3.5 to 21.5±3.9 mm at 6 weeks (P=0.0004), 20.6±3.4 mm at 6 months (P=0.0266), and 18.7±1.9 mm at 12 months (P=0.8021) postoperatively. Mean foraminal width improved from 7.9±2.0 to 10.2±2.8 mm at 6 weeks (P=0.0001), 9.4±2.6 mm at 6 months (P=0.0219) and 8.3±1.6 mm at 12 months (P=0.5734) postoperatively. Fusion rate at 6 and 12 months was 62.2% and 89.2%, respectively. A total of 6 patients (12%) had postoperative complications. Three patients (6%) had pain-related psoas muscle weakness and 3 patients (6%) had sensory neural complications that had resolved entirely by 8 and 16 weeks postoperatively, respectively. The study provides encouraging short and medium-term clinical and radiological results for DLIF. In this patient series, there was a low complication rate with no permanent neural injury reported.

Factors influencing disability in patients with chronic low back pain attending a tertiary hospital in sub-Saharan Africa

BackgroundVery little is known about the burden of chronic low back pain in Africa. This study aimed at assessing disability and associated factors in chronic low back patients in Cameroon.MethodsWe carried a hospital-based cross-sectional study including patients suffering from low back pain (LBP) of at least 12 weeks’ duration. Disability was assessed using the Roland Morris Disability Questionnaire (RMDQ). RMDQ > 4 described persons with dysfunctional levels of disability.Multivariable linear regression was used to investigate factors associated with higher RMDQ scores hence greater disability. Variables investigated included; gender, age, marital status, employment status and type, smoking history, alcohol consumption, income, pain intensity, LBP duration, psychological wellbeing, sleep satisfaction, leg pain, numbness/paresthesia, bowel/bladder dysfunction symptoms (BBDS), body mass index (BMI), and days of work absence.ResultsA sample of 136 adults (64% female) with a mean age of 50.6 ± 12.2 years participated in the study. Median duration of LBP was 33 (25th – 75th percentile: 12–81) months. Mean RMDQ score was 12.8 ± 6. In multivariable linear regression, pain intensity (β = 0.07, p = 0.002), longer days of work absence (β = 0.15, p = 0.003) and BBDS (β =2.33, p = 0.029) were associated with greater disability. Factors such as consumption of alcohol (β = − 3.55, p = 0.005) and higher psychological wellbeing scores (β = − 0.10, p = 0.004) significantly contributed to less disability (lower RMDQ scores). Dysfunctional levels of disability were present in 88.1% of patients.ConclusionCLBP is associated with significant disability and this relationship is driven by several factors. Multidisciplinary management strategies especially those targeted to improve pain control, manage BBDS and improve psychological wellbeing could reduce disability and improve quality of life.

A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain

In US emergency departments (EDs), patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and muscle relaxants. We compare functional outcomes among patients randomized to a 1-week course of naproxen+placebo versus naproxen+orphenadrine or naproxen+methocarbamol. This was a randomized, double-blind, comparative effectiveness trial conducted in 2 urban EDs. Patients presenting with acute, nontraumatic, nonradicular low back pain were enrolled. The primary outcome was improvement on the Roland-Morris Disability Questionnaire (RMDQ) between ED discharge and 1 week later. All patients were given 14 tablets of naproxen 500 mg, to be used twice a day, as needed for low back pain. Additionally, patients were randomized to receive a 1-week supply of orphenadrine 100 mg, to be used twice a day as needed, methocarbamol 750 mg, to be used as 1 or 2 tablets 3 times per day as needed, or placebo. All patients received a standardized 10-minute low back pain educational session before discharge. Two hundred forty patients were randomized. Baseline demographic characteristics were comparable. The mean RMDQ score of patients randomized to naproxen+placebo improved by 10.9 points (95% confidence interval [CI] 8.9 to 12.9). The mean RMDQ score of patients randomized to naproxen+orphenadrine improved by 9.4 points (95% CI7.4 to 11.5). The mean RMDQ score of patients randomized to naproxen+methocarbamol improved by 8.1 points (95% CI 6.1 to 10.1). None of the between-group differences surpassed our threshold for clinical significance. Adverse events were reported by 17% (95% CI 10% to 28%) of placebo patients, 9% (95% CI 4% to 19%) of orphenadrine patients, and 19% (95% CI 11% to 29%) of methocarbamol patients. Among ED patients with acute, nontraumatic, nonradicular low back pain, combining naproxen with either orphenadrine or methocarbamol did not improve functional outcomes compared with naproxen+placebo.

Diazepam Is No Better Than Placebo When Added to Naproxen for Acute Low Back Pain

Low back pain causes more than 2.5 million visits to US emergency departments (EDs) annually. Low back pain patients are often treated with nonsteroidal anti-inflammatory drugs and benzodiazepines. The former is an evidence-based intervention, whereas the efficacy of the latter has not been established. We compare pain and functional outcomes 1 week and 3 months after ED discharge among patients randomized to a 1-week course of naproxen+diazepam versus naproxen+placebo. This was a randomized, double-blind, comparative efficacy clinical trial conducted in an urban health care system. Patients presenting with acute, nontraumatic, nonradicular low back pain of no more than a duration of 2 weeks were eligible for enrollment immediately before discharge from an ED if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a validated 24-item inventory of functional impairment caused by low back pain. Higher scores on the questionnaire indicate greater functional disability. The primary outcome in the trial was improvement in the score between ED discharge and 1 week later. Secondary outcomes included pain intensity 1 week and 3 months after ED discharge, as measured on a 4-point descriptive scale (severe, moderate, mild, and none). All patients were given 20 tablets of naproxen 500 mg, to be taken twice a day as needed for low back pain. Additionally, patients were randomized to receive either 28 tablets of diazepam 5 mg or identical placebo, to be received as 1 or 2 tablets every 12 hours as needed for low back pain. All patients received a standardized 10-minute low back pain educational session before discharge. Using a between-group mean difference of 5 Roland-Morris Disability Questionnaire points, a previously validated threshold for clinical significance, we calculated the need for at least 100 patients with primary outcome data. Enrollment began in June 2015 and continued for 9 months. Five hundred forty-five patients were screened for eligibility. One hundred fourteen patients met selection criteria and were randomized. Baseline demographic characteristics were not substantially different between the 2 groups. One hundred twelve patients (98%) provided 1-week outcome data. The mean Roland-Morris Disability Questionnaire score of patients randomized to naproxen+diazepam improved by 11 (95% confidence interval [CI] 9 to 13), as did the mean score of patients randomized to naproxen+placebo (11; 95% CI 8 to 13). At 1-week follow-up, 18 of 57 diazepam patients (32%; 95% CI 21% to 45%) reported moderate or severe low back pain versus 12 of 55 placebo patients (22%; 95% CI 13% to 35%). At 3-month follow-up, 6 of 50 diazepam patients (12%; 95% CI 5% to 24%) reported moderate or severe low back pain versus 5 of 53 placebo patients (9%; 95% CI 4% to 21%). Adverse events were reported by 12 of 57 diazepam patients (21%; 95% CI 12% to 33%) and 8 of 55 placebo patients (15%; 95% CI 7% to 26%). Among ED patients with acute, nontraumatic, nonradicular low back pain, naproxen+diazepam did notimprove functional outcomes or pain compared with naproxen+placebo 1 week and 3 months after ED discharge.

Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures

BackgroundWe present the results of a randomized controlled trial evaluating the efficacy of vertebroplasty versus kyphoplasty in treating vertebral body compression fractures.MethodsPatients with vertebral body compression fractures were randomly assigned...