Roland Disability Questionnaire Research Articles

Functional Disability Due to Chronic Low Back Pain in the Geriatric Population of a Tertiary Care Hospital in North India: A Cross-Sectional Study.

Background Chronic low back pain (CLBP) is one of the painful and disabling conditions affecting the young as well as the geriatric population. There is a limited body of research to find out the impact of CLBP and functional disability on geriatric adults in the Indian region. Aim This study aims to determine the prevalence of functional disability due to CLBP in the geriatric population and to investigate the correlation between functional disability due to CLBP and other sociodemographic factors. Methodology A total of 157 geriatric adults were enrolled in the study, fulfilling the inclusion and exclusion criteria. Basic sociodemographic data, along with a clinical-radiological examination, was recorded. The Numeric Pain Rating Scale (NPRS), the Roland and Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale were used as study tools. Summary measures (frequency, mean, median, etc.) are calculated according to the level of measurement of variables. The point prevalence of functional disability due to CLBP in the geriatric population, along with 95% confidence intervals, has been calculated. The prevalence estimates were estimated and calculated with SD variables using a t-test, chi-square test, or Fisher's exact test under bivariate analysis. The linear/logistic regression analysis was used to control for the effects of covariates. A significance level of 5% was set for all analyses due to the exploratory nature of the study. Statistical significance was considered at p < 0.05. Results According to the Roland and Morris Disability Questionnaire, 29% (N = 46) of the study geriatric participants had a severe disability, 45% (N = 70) had a moderate disability, and 26% (N = 41) had a mild disability. According to the Quebec Back Pain Disability Scale, 34% (N = 53) had scored more than 50, and 66% (N = 104) had scored less than 50. Statistically significant correlations have been found between the level of functional disability and intensity of pain (NPRS score), gender, associated illness, current and past occupation, and clinical diagnosis of CLBP (p < 0.05). Conclusion The prevalence of functional disability due to CLBP is higher in the geriatric population. It is associated with many influencing sociodemographic factors like gender, occupation, associated musculoskeletal illness, the intensity of low back pain, and clinico-radiological diagnosis. Early identification and timely interventions to reduce functional disability due to CLBP and associated risk factors are the need of the hour. Regular back muscle exercises, ergonomic modifications, and modification of activities of daily life are recommended to prevent functional disability due to CLBP.

Unilateral biportal endoscopy vs. open decompression for lumbar epidural lipomatosis-cohort study using a prospective registry.

This study aimed to compare the outcomes of unilateral biportal endoscopy, unilateral laminectomy bilateral decompression (UBE-ULBD), and open lumbar decompression (OLD) in patients with lumbar epidural lipomatosis (LEL). This prospective observational study was conducted from March 2019 to May 2022 and encompassed 33 patients with LEL who underwent lumbar decompression. The study included 15 cases of UBE-ULBD decompression and 18 cases of open decompression, which were followed up for 1 year. The baseline characteristics, initial clinical manifestations, and surgical details [including estimated blood loss (EBL) and preoperative complications] of all patients were recorded. Radiographic evaluation included the cross-sectional area (CSA) of the thecal sac and paraspinal muscles on MRI. Clinical results were analyzed using the Short Form-36 Score (SF-36), the Numeric Pain Rating Scale (NRS) for lumbar and leg pain, creatine kinase, the Roland and Morris Disability Questionnaire (RMDQ), and the Oswestry Disability Index (ODI). The dural sac CSA increased considerably at the 1-year postoperative follow-up in both groups (p < 0.001). The operative duration in the OLD group (48.2 ± 7.2 min) was shorter than that in the UBE-ULBD group (67.7 ± 6.3 min, p < 0.001). The OLD group (97.2 ± 19.8 mL) was associated with more EBL than the UBE-ULBD group (40.6 ± 13.6 mL, p < 0.001). The duration of hospitalization in the OLD group (5.4 ± 1.3 days) was significantly longer compared with the UBE-ULBD group (3.5 ± 1.2 days, p < 0.01). The SF-36, NRS, RMDQ, and ODI scores improved in both groups postoperatively (p < 0.001). Serum creatine kinase values in the UBE-ULBD group (101.7 ± 15.5) were significantly lower than those in the OLD group (330.8 ± 28.1 U/L) 1 day after surgery (p < 0.001). The degree of paraspinal muscle atrophy in the UBE-ULBD group (4.81 ± 1.94) was significantly lower than that in the OLD group (12.15 ± 6.99) at 1 year (p < 0.001). UBE-ULBD and OLD demonstrated comparable clinical outcomes in treating LEL. However, UBE-ULBD surgery was associated with shorter hospital stays, lower rates of incision infection, lighter paravertebral muscle injury, and lower EBL than OLD surgery. Consequently, UBE-ULBD can be recommended in patients with LEL if conservative treatment fails.

Long-term impact of self-compassion training with core stability exercise on patients with nonspecific chronic low back pain: A randomized controlled trial

ObjectiveTo compare the long-term effectiveness of self-compassion therapy (SCT) combined with core stability exercise (CSE) versus CSE alone in managing nonspecific chronic low back pain (NCLBP). MethodsThe combined group received SCT and CSE, while the exercise group only received CSE. Treatment was administered once weekly for four weeks, followed by one year of follow-up. The primary outcomes were changes in functional limitations (measured by Roland and Morris Disability Questionnaire scores[RMDQ]) and self-reported back pain (measured by the Numeric Pain Rating Scale[NRS]) at 52 weeks, with assessments also conducted at 2, 4, and 16 weeks. Results52 (83.9%) completed the follow-up assessments and were included in the analysis (42 women [80.8%]; mean [SD] age,35.3 [10.0] years). In the combined group, the baseline mean (SD) RMDQ score was 9.3 (4.1),5.7 (5.8) at 2 weeks, 3.8 (3.4) at 4 weeks, 3.8 (3.7) at 16 weeks, and 2.4 (2.7) at 52 weeks. For the exercise group, the RMDQ scores were 8.2 (3.3) at baseline, 6.2 (4.2) at 2 weeks, 5.5 (4.7) at 4 weeks, 4.4 (4.5) at 16 weeks, and 5.2 (5.6) at 52 weeks. The estimated mean difference between the groups at 52 weeks was −3.356 points (95% CI, −5.835 to −0.878; P = 0.009), favoring the combined group. NRS scores showed similar changes. ConclusionThe addition of self-compassion therapy enhances the long-term efficacy of core stability training for NCLBP (Preregistered at chictr.org.cn:ChiCTR2100042810).

An Assessment of the Longitudinal Construct Validity of the Pain Behavioral Scale (PaBS) in a Saudi Population with Chronic Low Back Pain: A Preliminary Study.

Background: The Pain Behavioral Scale (PaBS) measures the presence and severity of pain behavior. We examine the longitudinal construct validity of the PaBS using convergent and known-groups approaches on a population of 23 participants with chronic lower back pain (LBP) undergoing routine physiotherapy care and pain neuroscience education. Methods: Participants who satisfied study inclusion and exclusion criteria were recruited from patients who attended two testing sessions at physiotherapy clinics in Saudi Arabia. Participant pain behavior was initially measured using the PaBS scale; participants performed standardized physical tests (e.g., repeated trunk flexion) and provided baseline demographic, clinical data, and self-reported measurements using the Modified Roland and Morris disability questionnaire (MODI), fear-avoidance questionnaire (FABQ), and pain catastrophizing scale (PCS). In subsequent visits, a physiotherapist provided usual care to participants, and weekly sessions were established for online pain-neuroscience education. During week six, participants repeated the same questionnaires and physical performance tests with the PaBS. Paired t-tests are used to compare changes in health characteristics from baseline responses to those in week six. Correlations between changes in PaBS from baseline to week six, with changes in outcome measures (i.e., disability, pain intensity, fear-avoidance beliefs, catastrophizing), were determined. To assess known-group validity, we also used a general linear model. Results: A total of 23 participants completed the PNE and follow-up data collection. The mean change from baseline in the PaBS score was statistically significant, as were changes in MODI, FABQ, and PCS. Almost 70% of participants improved their PaBS scores over the six-week period, with PaBS scores of almost 40% of them improving by three units or more. The change in PaBS score correlated significantly with changes in the PCS-rumination subscale, supporting a proposed approach to estimate convergent validity (r = 0.44, 95% CI = 0.04-0.72, p = 0.035). Conclusions: The mean change from baseline in the PaBS score is statistically significant, as are changes in MODI, FABQ, and PCS, supporting its convergent validity. According to our STarT Back groups, the medium to low-risk group had a lower PaBS score, and high-risk group had a higher PaBS score, indicating that PaBS use in clinical assessment may identify people according to pain-behavior severity, or those at increased risk of developing disability.

Moderators and Nonspecific Predictors of Treatment Benefits in a Randomized Trial of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy vs Usual Care for Chronic Low Back Pain

Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP), but little is known regarding who might benefit more from one than the other. Using data from a randomized trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with CLBP (N = 297), we examined baseline characteristics that moderated treatment effects or were associated with improvement regardless of treatment. Outcomes included 8-week function (modified Roland Disability Questionnaire), pain bothersomeness (0–10 numerical rating scale), and depression (Patient Health Questionnaire-8). There were differences in the effects of CBT versus MBSR on pain based on participant gender (P = .03) and baseline depressive symptoms (P = .01), but the only statistically significant moderator after Bonferroni correction was the nonjudging dimension of mindfulness. Scores on this measure moderated the effects of CBT versus MBSR on both function (P = .001) and pain (P = .04). Pain control beliefs (P <.001) and lower anxiety (P < .001) predicted improvement regardless of treatment. Replication of these findings is needed to guide treatment decision-making for CLBP. Trial RegistrationThe trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843). PerspectiveAlthough few potential moderators and nonspecific predictors of benefits from CBT or MBSR for CLBP were statistically significant after adjustment for multiple comparisons, these findings suggest potentially fruitful directions for confirmatory research while providing reassurance that patients could reasonably expect to benefit from either treatment.

Does m-health-based exercise (guidance plus education) improve efficacy in patients with chronic low-back pain? A preliminary report on the intervention’s significance

BackgroundThe utilization of mobile health (m-health) has rapidly expanded during the COVID-19 pandemic, and there is still a lack of relevant clinical data pertaining to chronic low-back pain (CLBP) management. This study was designed to compare the effectiveness of m-health-based exercise (via guidance plus education) versus exercise (via guidance) during CLBP management.MethodsParticipants (n = 40) were randomly assigned to intervention and control groups. The intervention group received m-health-based exercise (via guidance plus education), whereas the control group received m-health-based exercise (via guidance). The exercise prescription video and educational content were sent to participants by the application (app), Ding Talk. Repeated-measures analysis of variance was used to test the baseline’s intervention effects, 6-week follow-up, and 18-week follow-up. We selected function (Roland and Morris Disability Questionnaire) and pain intensity (current, mean, and most severe Numeric Rating Scale in the last 2 weeks) as the primary outcomes, changes of negative emotion (depression, anxious), and quality of life as the secondary outcomes.ResultsTime’s significant effect was found in pain, function, and health-related quality of life in both groups, but time did not show significant interaction effects. Participants were able to use m-based education with their anxiety and depression after treatment, but the relief only lasted until week 6. No differences were found on the aspect of mental health-related quality of life.ConclusionPreliminary findings suggest that m-health-based exercise (via guidance) may be a convenient and effective method to treat CLBP. However, additional health education didn't help more. More rigorous controlled trials are needed to improve the therapeutic effect in future studies.Trial registrationChinese Clinical Trials Registry Number ChiCTR2000041459. Registered on December 26, 2020.

Proprioceptive neuromuscular facilitation exercises versus lumbar stabilization exercises for chronic low back pain patients: A randomized interventional study

Background: Chronic low back pain causes discomfort and disturbance in the mechanoreceptor and proprioception centers. Exercises improve muscle strength, flexibility, endurance, and ability to perform life activities. Proprioceptive neuromuscular facilitation (PNF) involves stretching, resisted movements which improves muscle disharmony, atrophy, and joint movement limitation. Lumbar stabilization exercises (LSE) develop the awareness of muscle contraction and control from simple to complex patterns. Both exercises are effective individually in chronic low back pain patients. This study was conducted to find out which technique is better. Objectives: The objective of the study is to determine the efficacy of PNF versus LSE program in chronic low back pain patients. Study Design: A Randomized study was conducted. Methods: A prospective, interventional study was conducted on patients with mechanical low back pain of more than 3 months, in both males and females, of age 20–45 years. Patients having systemic illness, central or peripheral neurologic signs, and specific causes of low back pain were excluded. Individuals having systemic illness and psychiatric illness were also excluded from the study. Twenty-two patients were selected and divided into two groups. Patients were assessed on the Visual Analog Scale (VAS), modified Schober's test, Modified Oswestry Low Back Pain Disability Questionnaire (ODI), Roland and Morris Low Back Pain and Disability Questionnaire (RMDQ). Patients in the PNF Group received concentric and eccentric contractions of agonist and antagonist muscles, patterns such as chopping, lifting, bilateral leg, and trunk lateral flexion. LSE Group received core strengthening exercises. Both group received 3 treatment sessions per week for 4 weeks, each session lasting for 45 min. Results: PNF group showed significant improvement in pain on VAS (P = 0.003; 95% confidence interval [CI[, 2.15–3.01), in disability on ODI (P = 0.001, 95% CI, 12.09–20.1), and in lumbar flexibility Modified Schober's test (P = 0.000, 95% CI, 5.15–5.93) On RMDQ, there was no statistically significant difference between PNF and LSE groups (P = 0.061, 95% CI, 6.87–8.97). Conclusion: There was a significant improvement seen in the pain and disability which was assessed on VAS and ODI in the PNF group over LSE. Hence, PNF exercises can be incorporated with LSE in the treatment of LBP.

Decompression alone versus decompression and instrumented fusion for the treatment of isthmic spondylolisthesis: a randomized controlled trial.

The most advocated surgical technique to treat symptoms of isthmic spondylolisthesis is decompression with instrumented fusion. A less-invasive classical approach has also been reported, which consists of decompression only. In this study the authors compared the clinical outcomes of decompression only with those of decompression with instrumented fusion in patients with isthmic spondylolisthesis. Eighty-four patients with lumbar radiculopathy or neurogenic claudication secondary to low-grade isthmic spondylolisthesis were randomly assigned to decompression only (n = 43) or decompression with instrumented fusion (n = 41). Primary outcome parameters were scores on the Roland Disability Questionnaire (RDQ), separate visual analog scales (VASs) for back pain and leg pain, and patient report of perceived recovery at 12-week and 2-year follow-ups. The proportion of reoperations was scored as a secondary outcome measure. Repeated measures ANOVA according to the intention-to-treat principle was performed. Decompression alone did not show superiority in terms of disability scores at 12-week follow-up (p = 0.32, 95% CI -4.02 to 1.34), nor in any other outcome measure. At 2-year follow-up, RDQ disability scores improved more in the fusion group (10.3, 95% CI 3.9-8.2, vs 6.0, 95% CI 8.2-12.4; p = 0.006, 95% CI -7.3 to -1.3). Likewise, back pain decreased more in the fusion group (difference: -18.3 mm, CI -32.1 to -4.4, p = 0.01) on a 100-mm VAS scale, and a higher proportion of patients perceived recovery as showing "good results" (44% vs 74%, p = 0.01). Cumulative probabilities for reoperation were 47% in the decompression and 13% in the fusion group (p < 0.001) at the 2-year follow-up. In patients with isthmic spondylolisthesis, decompression with instrumented fusion resulted in comparable short-term results, significantly better long-term outcomes, and fewer reoperations than decompression alone. Decompression with instrumented fusion is a superior surgical technique that should in general be offered as a first treatment option for isthmic spondylolisthesis, but not for degenerative spondylolisthesis, which has a different etiology.

Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial.

The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomized 63 patients with aLBP 1:1 into two groups receiving either rESWT (intervention) or sham rESWT (placebo) with a manipulated shockwave head not delivering any shockwaves. Both, rESWT and sham procedure were carried out eight times for four weeks. Both groups received additional analgesics and physiotherapy twice a week. Primary patient-reported outcome measure (PROM) was the visual analogue scale for aLBP (VAS-LBP). Secondary PROMs included the Oswestry disability index (ODI), Roland and Morris Disability Questionnaire (RDQ), EuroQol EQ-5D-3L, and the Beck Depression Index (BDI-II). Primary endpoint was a between-arm comparison of mean changes in VAS-LBP from baseline to final FU. At randomization, there were no differences between the two groups in relation to age and PROMs. Both groups showed significant improvement in all PROMs at final FU. VAS-LBP declined by 60.7% (p < 0.001) in the intervention and by 86.4% (p < 0.001) in the sham group. The intervention group showed significantly less pain relief after 4 and 12 weeks. The EQ-5D submodality pain showed significantly inferior results for the intervention (1.5 (0.58)) compared to the sham group (1.1 (0.33)) (p < 0.014) after eight weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II. Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life. To the best of our knowledge, this is the first study with a high level of evidence reporting the efficacy of rESWT in aLBP treatment and will be a future basis for decision-making.

Efficacy and safety of thread embedding acupuncture combined with acupuncture for chronic low back pain: A randomized, controlled, assessor-blinded, multicenter clinical trial.

Background:Low back pain is a very common disease. Many patients with chronic low back pain (CLBP) have been treated by complementary and alternative medicine such as acupuncture (AT) treatment. A type of AT, thread embedding acupuncture (TEA), consists of a thread that can continually stimulate at the AT points and has mechanical and chemical effects. Although TEA was widely used in clinical practice, there was little evidence of its efficacy and safety for CLBP.Methods:This clinical trial was randomized, controlled, assessor-blinded, two-armed, parallel, and conducted in multiple centers. Four Korean medical institutions recruited 38 outpatients with CLBP. The participants were randomly allocated to a treatment group (TEA combined with AT) or a control group (only AT) in a 1:1 ratio. All participants received conventional AT twice a week for 8 weeks (16 sessions) at 15 AT points (GV3 and bilateral BL23, BL24, BL25, BL26, BL40, BL60, and EX-B5) and the treatment group participants additionally received TEA once a week for 8 weeks (8 sessions) on 10 AT points in the multifidus, spinal erector, and lumbar quadrate muscles. The primary outcome measure of this study was the change of visual analog scale (VAS) from baseline (0 week) to the end of intervention (8 weeks). Secondary outcome measures included clinically relevant improvement (minimal clinically important difference) and 3% to 50% decrease on VAS, disability level (Korean version of Roland and Morris disability questionnaire), quality of life (Korean version of European quality of life 5dimension), global assessment (patient global impression of change), economic analysis, credibility test, and safety assessment.Results:The treatment group showed a significant reduction in VAS scores when compared with the control group (–33.7 ± 25.1 vs –15.6 ± 17.0, P = .013). As for the secondary outcome measures, the treatment group showed significant difference in 50% decrease on VAS and patient global impression of change. There was no serious adverse event associated with TEA and AT.Conclusion:This clinical trial documents the efficacy and safety of TEA combined with AT for the management of CLBP.

Use of a Spinal Thermal Massage Device for Anti-oxidative Function and Pain Alleviation.

Background: Elderly people are vulnerable to a variety of diseases, including chronic pain, which reduces their levels of physical fitness. Thermal massage has been shown to relieve pain and activate antioxidant enzymes. The objective of this study was to determine whether thermal massaging of the spinal column can reduce muscle pain and induce antioxidant function.Methods: This study included participants aged ≥60 years with lower back pain. The participants were assigned to either an experimental group who received spinal column thermal massage and standard rehabilitative treatment or a control group who received standard rehabilitative treatment only. Data from a total of 116 participants (61 and 55 in the control and experimental groups, respectively) were used for analysis. Participants were assessed before treatment and at 4 (POST1) and 8 weeks (POST2) post-treatment, using a pain numeric rating scale (PNRS) and the Roland and Morris Disability Questionnaire (RMDQ), and by measuring the serum levels of superoxide dismutase (SOD), serum glutathione-peroxidase (GPx), and serum catalase (CAT).Results: The extent of pain reduction, as measured by the PNRS, was greater in the experimental group. The RMDQ score in the control group decreased at POST1, but the decrease was not maintained at POST2, whereas the decrease in POST1 in the experimental group continued until POST2. SOD concentrations were significantly higher in the experimental group at POST1 and POST2, and GPx levels were significantly higher in the experimental group at POST2; however, there were no changes in CAT concentrations. Incidentally, there was a significant correlation between antioxidant activity and pain perception in the experimental group.Conclusions: The study findings suggest that spinal column thermal massage reduces pain more effectively, improves self-reported levels of disability, and increases the antioxidant enzyme levels. Thermal massage may, therefore, be useful in the prevention and treatment of diseases associated with oxidation.

Community Pharmacist’s Role in Detecting Low Back Pain, and Patient Attitudes—A Cross-Sectional Observational Study in Italian Community Pharmacies

Background: Low back pain (LBP) is one of the most frequent diseases for which patients seek advice in a community pharmacy. The study aimed to evaluate the feasibility of the administration by community pharmacists of questionnaires to assess the LBP intensity and disability degree in patients entering community pharmacies and the attitudes they have toward pain management by pharmacological and non-pharmacological strategies. Methods: An explorative, cross-sectional, observational, and quantitative study was performed. Twelve Italian community pharmacists were asked to submit a questionnaire on LBP to patients visiting their pharmacies. The questionnaire included a pain intensity scale, and two validated tools: the Roland and Morris Disability Questionnaire (RMDQ) and the Start Back Screening Tool (SBST) to determine the degree and risk of patient disability, respectively. Results: 872 patients filled out the questionnaires in 6 months. No statistical differences between genders (p > 0.30) were recorded for pain intensity (Female: median score 6, IQR 4–7; Male: median scores 5, IQR 4–7; p > 0.30) and disability associated with LBP (RMDQ high-disability level: Females, 14.7%, Males, 15.0%; p > 0.90). Most of the patients (69%) reported a low degree of disability, but the risk of disability was medium and high in 36% and 18% of them, respectively (p < 0.05). About 14% of patients declare to never seek for physician’s advice despite their medium-high degree of disability. Conclusion: The study demonstrated the feasibility of validated tools for assessing the degree and risk of disability in LBP patients administrable in community pharmacies. Moreover, the community pharmacy resulted in an important care portal for patients suffering from moderate LBP and for intercepting patients who suffered from severe LBP but had never reported their problem to their physician.

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support...

Efficacy of Early Decompression Surgery Versus Epidural Injection in Management of Sciatica Due to Lumbar Disc Herniation–A Randomised Control Trial

Introduction: Sciatica is one of the most excruciating type of pain resulting due to irritation of the sciatic nerve in the lower back. Pain radiates along the distribution of the sciatic nerve in the lower limb. Lumbar disc herniation is commonly implicated as a cause of sciatica. Treatment options include initial conservative approach with epidural injection and analgesics and in patients with no relief decompression surgery performed. The short-term efficacy of the epidural injections is well established but the long-term outcome remains controversial. Even, spinal decompression surgeries have shown significant relief of symptoms at short term but in long term remain doubtful. This study attempts to compare both these treatment options in people with disabling chronic sciatic pain. Materials and Method: This prospective randomized controlled trial conducted on 25 patients for duration of 1 year with sciatica symptoms lasting for more than 6 weeks. Complete history and examination with imaging studies was carried out with pain assessment done by using a Roland Disability Questionnaire (RDQ) and Visual Analogue Scale (VAS). Follow up Assessment of the patient’s were done at regular interval of 0, 2, 4, 12, 26, 52 weeks post intervention. Results: Of the 25 patients 12 were assigned randomly to early surgery group and 13 to epidural injection group. Immediate post-op and follow up assessment showed significant improvement in pain and disability scores for patients randomized to early surgery group with a significant difference between areas under the curve. The short-term benefit of early surgery was no longer significant by 6 months and by the end of 1 year outcomes were similar between the two groups. Conclusion: Early surgery achieved more rapid relief of sciatica than conservative care, but outcomes were similar by one year in patients of both groups.

Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial

BackgroundLow back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP.MethodsThis study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed.DiscussionThe results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation.Trial registrationClinical Research Information Service, KCT0002998. Registered on 12 July 2018.

Therapeutic Efficacy and the Impact of the "Dose" Effect of Acupuncture to Treat Sciatica: A Randomized Controlled Pilot Study.

PurposeTo investigate the required sample size for and feasibility of a full-scale randomized controlled trial examining the impact of the “dose” effect of acupuncture in treating sciatica.Patients and methodsFifty-seven patients with sciatica, aged 35–70 years, were recruited and screened. Thirty-one participants were randomly assigned to receive “low-dose” manual acupuncture (MAL) (n= 15) or “high-dose” manual acupuncture (MAH) (n=16). The acupuncture treatment was administered twice weekly for 4 weeks. The primary outcome was the visual analog scale (VAS) score at baseline and after 4 weeks of acupuncture treatment. Secondary outcomes included the Roland Disability Questionnaire for Sciatica (RDQS), the Sciatica Bothersomeness Index (SBI), and the World Health Organization Quality of Life in the Brief Edition (WHOQOL-BREF) scores at baseline and after 4 weeks of acupuncture treatment.ResultsThirty patients completed the study. For all patients, acupuncture achieved significant improvement in the VAS (5.48±2.0, p<0.001), RDQS (3.18±2.83, p=0.004), and SBI (2.85±3.23, p=0.008) scores, but not in the WHOQOL-BREF scores. In the between-group analysis, the assessed scales showed no significant differences between the MAL and MAH groups. However, based on the level of chronicity, the MAH group demonstrated greater improvement in the outcomes and a significant benefit in the physical subscale of the WHOQOL-BREF (p<0.05).ConclusionResults of this pilot study indicate that acupuncture is safe and may effectively relieve symptoms and disability in patients with non-acute sciatica. MAL was as effective as MAH in treating sciatica. A subsequent trial with a larger sample size (estimated at n=96) is required to confirm whether patients with a high level of chronicity would benefit from MAH treatment.Trial registrationNCT03489681.

Is there a relationship between self-efficacy, disability, pain and sociodemographic characteristics in chronic low back pain? A multicenter retrospective analysis

BackgroundPain-related self-efficacy is defined as the beliefs held by people with chronic pain that certain activities can be carried out despite the pain. Poor self-efficacy is an obstacle to the recovery and predicts long-term disability. The aims of this study are to investigate the prevalence of poor pain self-efficacy in Italian subjects with chronic low back pain (LBP), and to inquire the relationships between self-efficacy, disability, pain, and main demographic and clinical characteristics.MethodsA secondary multicenter retrospective analysis was done on 310 outpatients with chronic non-specific LBP. The pain self-efficacy measured with the Pain Self-Efficacy Questionnaire (PSEQ), the disability measured with the Roland & Morris Disability Questionnaire, and the pain intensity measured with the Numerical Rating Scale were considered variables to investigate, whereas demographic and clinical variables were considered predictors or potential confounders. A 40/60 PSEQ score was adopted as cut-off to distinguish between good and poor self-efficacy.Results199 subjects (64.2% of the sample) showed poor self-efficacy. The odds of having poor self-efficacy appeared significantly related to female gender (OR = 1.80, 95%CI [1.12;2.90]; p = 0.015) and drugs use (OR = 1.68, 95%CI [1.06;2.70]; p = 0.029). Significant relationships also emerged between disability and higher age (β = 0.07, 95%CI [0.01; 0.12]; p = 0.02), being female (β = 1.80, 95%CI [0.32;3.29]; p = 0.018), low educational level (β = − 1.68, 95%CI [− 2.59;-3.29]; p < 0.001), higher height (β = − 0.08, 95%CI [− 0.158;-0.002]; p = 0.045), pain duration [mos] (β = 0.01, 95%CI [0.001;0.021]; p = 0.041), and drugs use (β = 2.86, 95%CI [1.44;4.27]; p < 0.001). The amount of pain appeared significantly related to educational level (β = − 0.47, 95%CI [− 0.76;-0.182]; p < 0.001), smoking (β = 0.56, 95%CI [0.09; 1.03]; p = 0.021), height (β = − 0.03, 95%CI [− 0.05; − 0.002]; p = 0.036), and drugs use (β = 0.81, 95%CI [0.399;1.22]; p < 0.001). No significant correlation appeared among weight, body mass index, and referred pain neither in relation to self-efficacy, nor in relation to pain/disability.ConclusionsThe majority of our sample, composed of Italian people complained of chronic LBP, shows poor self-efficacy. Female gender and drugs use are significantly related to poor self-efficacy, low educational level negatively influences the amount of perceived pain and disability, and older age and smoking are related to disability and pain intensity, respectively. The knowledge of these sociodemographic and clinical characteristics potentially influencing chronic LBP may be useful to address more efforts towards the most negatively impacted subjects, among the entire population complained of chronic LBP.

Disc inflammation and Modic changes show an interaction effect on recovery after surgery for lumbar disc herniation

PurposeTo study the interaction between Modic changes (MC) and inflammation by macrophages in the disc, in relation to clinical symptoms before and after discectomy for lumbar disc herniation.MethodsDisc tissue was embedded in paraffin and stained with haematoxylin and CD68. Subsequently, tissue samples were categorized for degree of inflammation. Type of MC was scored on MRI at baseline. Roland Disability Questionnaire (RDQ) score and visual analogue scale for back pain and leg pain separately were considered at baseline and 1-year follow-up post-surgery. Main and interaction effects of MC and inflammation were tested against clinical outcome questionnaires. In addition, this analysis was repeated in bulging and extruded discs separately.ResultsDisc material and MRI’s of 119 patients were retrieved and analysed. Forty-eight patients demonstrated mild inflammation, 45 showed moderate inflammation, and 26 showed considerable inflammation. In total, 49 out of 119 patients demonstrated MC. Grade of disc inflammation did not associate with the presence of MC. At baseline, no main or interaction effects of MC and inflammation were found on the clinical scores. However, during follow-up after discectomy, significant interaction effects were found for RDQ score: Only in patients with MC at baseline, patients remained significantly more disabled (3.2 points p = 0.006) if they showed considerable disc inflammation compared to patients with mild inflammation. The additional analysis showed similar results in extruded discs, but no significant effects in bulging discs.ConclusionsAn interaction effect of MC and disc inflammation by macrophages is present. Only in patients with MC, those with considerable inflammation recover less satisfactory during follow-up after surgery.Graphic abstractThese slides can be retrieved under Electronic Supplementary Material.

Effects of pulsed low-frequency magnetic field therapy on pain intensity in patients with musculoskeletal chronic low back pain: study protocol for a randomised double-blind placebo-controlled trial

IntroductionThe aim of the present study is to investigate the effectiveness of pulsed low-frequency magnetic field (PLFMF) on the management of chronic low back pain (CLBP).Methods and analysisA randomised double-blinded...

Outcome of unilateral versus standard open midline approach for bilateral decompression in lumbar spinal stenosis: is "over the top" really better? A Swiss prospective multicenter cohort study.

In this retrospective analysis of a prospective multicenter cohort study, the authors assessed which surgical approach, 1) the unilateral laminotomy with bilateral spinal canal decompression (ULBD; also called "over the top") or 2) the standard open bilateral decompression (SOBD), achieves better clinical outcomes in the long-term follow-up. The optimal surgical approach (ULBD vs SOBD) to treat lumbar spinal stenosis remains controversial. The main outcomes of this study were changes in a spinal stenosis measure (SSM) symptoms score, SSM function score, and quality of life (sum score of the 3-level version of the EQ-5D tool [EQ-5D-3L]) over time. These outcome parameters were measured at baseline and at 12-, 24-, and 36-month follow-ups. To obtain an unbiased result on the effect of ULBD compared to SOBD the authors used matching techniques relying on propensity scores. The latter were calculated based on a logistic regression model including relevant confounders. Additional outcomes of interest were raw changes in main outcomes and in the Roland and Morris Disability Questionnaire from baseline to 12, 24, and 36 months. For this study, 277 patients met the inclusion criteria. One hundred forty-nine patients were treated by ULBD, and 128 were treated by SOBD. After propensity score matching, 128 patients were left in each group. In the matched cohort, the mean (95% CI) estimated differences between ULBD and SOBD for change in SSM symptoms score from baseline to 12 months were -0.04 (-0.25 to 0.17), to 24 months -0.07 (-0.29 to 0.15), and to 36 months -0.04 (-0.28 to 0.21). For change in SSM function score, the estimated differences from baseline to 12 months were 0.06 (-0.08 to 0.21), to 24 months 0.08 (-0.07 to 0.22), and to 36 months 0.01 (-0.16 to 0.17). Differences in changes between groups in EQ-5D-3L sum scores were estimated to be -0.32 (-4.04 to 3.40), -0.89 (-4.76 to 2.98), and -2.71 (-7.16 to 1.74) from baseline to 12, 24, and 36 months, respectively. None of the group differences between ULBD and SOBD were statistically significant. Both surgical techniques, ULBD and SOBD, may provide effective treatment options for DLSS patients. The authors further determined that the patient outcome results for the technically more challenging ULBD seem not to be superior to those for the SOBD even after 3 years of follow-up.