The Effects of Quality Assurance System Implementation on Work Well-Being and Patient Safety: Protocol for a Mixed Methods Study.

BACKGROUND: Systematic monitoring of work atmosphere and patient safety incidents is a necessary part of a quality assurance system, particularly an accredited system like the Joint Commission International (JCI). How the implementation of quality assurance systems affects well-being at work and patient safety is unclear. Evidence shows that accreditation improves workplace atmosphere and well-being. Thus, the assumption that an increase in employees' well-being at work improves patient safety is reasonable. OBJECTIVE: This study aims to describe the protocol for monitoring the effects of implementing the quality assurance system of JCI at Orton Orthopedic Hospital on employees' well-being (primary outcome) and patient safety (secondary outcome). METHODS: Quantitative (questionnaires and register data) and qualitative (semistructured interviews) methods will be used. In addition, quantitative data will be collected from register data. Both quantitative and register data will be analyzed. Register data analysis will be performed using generalized linear models with an appropriate distribution and link function. The study timeline covers the time before, during, and after the start of the accreditation process. The collected data will be used to compare job satisfaction, as a part of the well-being questionnaire, and the development of patient safety during the accreditation process. RESULTS: The results of the quality assurance system implementation illuminate its possible effects on the patient's safety and job satisfaction. The repeatability and internal consistency reliability of the well-being questionnaire will be reported. Data collection will begin in May, 2024. It will be followed by data analysis and the results are expected to be published by 2025. CONCLUSIONS: The planned study will contribute to the evaluation of the effects of JCI accreditation in terms of well-being at work and patient safety. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45200.

The Efficacy and Feasibility of an Interoceptive Exposure Technique for Preventing the Transition From Subacute to Chronic Back Pain by Altering the Emotional Response to Pain: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Psychological factors such as stress, anxiety, mood, emotions, cognitive functioning, and pain behavior are relevant to the onset of pain and its continuation in the transition to chronic conditions. Subacute low back pain (LBP), a precursor to chronic LBP, is particularly poorly understood, and its relationships with psychological factors are understudied. OBJECTIVE: We will conduct a study aiming to prevent the chronicity of subacute LBP by altering the emotional response to pain using an interoceptive exposure technique (IET). Considering the recent increase in knowledge about psychological risk factors, as well as recent findings in cognitive neuroscience regarding emotional and cognitive background factors in the LBP chronicity process, efforts should be made to discover effective preventive methods. METHODS: We present a novel method aiming to prevent the transition from subacute to chronic back pain by altering the emotional response to pain using an IET. In this pilot randomized controlled trial, participants who are at a higher risk of LBP chronification due to the presence of a biomarker (ie, functional connectivity between the medial prefrontal cortex and nucleus accumbens) will be randomly assigned to the IET intervention group or control group A (treatment as usual). Participants who do not present with the biomarker will be assigned to control group B (treatment as usual) to assess how well this biomarker predicts the chronification of subacute LBP in this study population. Questionnaires measuring the pain experience and psychological distress will be used before the intervention, after the intervention (at 3 months), and at the 12-month follow-up. RESULTS: This research project will combine 2 novel methods: a biomarker as the inclusion criterion and an IET as the intervention. The comparative study design enables evaluation of the efficacy of the IET, as well as replication of the biomarker's validity as a possible clinical screening method. CONCLUSIONS: If found to be useful, the IET would offer a cost-effective and reasonable way to develop treatment for acute and subacute back pain conditions. Potential benefits include increased pain management and quality of life for the individual patient with the addition of a potentially useful functional pain management method at the societal level. TRIAL REGISTRATION: ClinicalTrials.gov NCT05450263; https://clinicaltrials.gov/ct2/show/NCT05450263. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45701.

Impact of antidepressant medication on the analgetic effect of repetitive transcranial magnetic stimulation treatment of neuropathic pain. Preliminary findings from a registry study.

OBJECTIVES: Repetitive transcranial magnetic stimulation (rTMS) has been found to be effective in chronic neuropathic pain conditions. However, information about the combined effects of rTMS and antidepressant treatment is scarce. We studied the outcome of rTMS and concurrent antidepressant treatment in patients with neuropathic pain. METHODS: In this retrospective, real-world study, 34 patients with neuropathic pain, who were considered resistant or not benefitting from conventional treatment, received rTMS treatment between 2017 and 2020. Pain-related factors were measured using the Numerical Rating Scale (NRS), Global Impression of Change (GIC), and Beck Depression Inventory. RESULTS: A decrease in pain intensity and pain interference assessed with NRS was observed after 10 treatment sessions in 16 patients. The impression of change was positive in 20 patients. Half of the patients (n=17) used antidepressant medication, while half (n=17) did not. A concurrent use of antidepressants with therapeutic rTMS was significantly linked with less pain intensity relief when compared with the nonuse of antidepressants (p=0.019). The impression of change was significantly in favor of the antidepressant nonuser group (p=0.002). No group differences in pain interference were found between the groups. CONCLUSIONS: Therapeutic rTMS for neuropathic pain is plausibly sensitive to interference with antidepressant medication. The exact mechanism of our findings remains to be elucidated; confirmatory studies are warranted.

Functional Tests Predicting Return to Work of Workers with Non-Specific Low Back Pain: Are There Any Validated and Usable Functional Tests for Occupational Health Services in Everyday Practice? A Systematic Review.

The literature predominantly advocates subjective perception of disability and pain as an outcome measure for the functional evaluation of patients with low back pain (LBP). Physical outcome measurements are almost completely ignored. In this systematic review, we focused on physical functional measurements that can contribute to the prediction of patients' return to work (RTW) readiness after sick leave or rehabilitation. Searches were conducted in July 2022 without any time limit in the Cochrane Library, PEDro, PubMed and Scopus databases for functional and clinical tests reliable and applicable in clinical practice without demanding equipment. Two independent researchers extracted the data from the included articles in a standardised data collection form, and a third researcher validated the data extraction. No date restriction was applied. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in conducting the review. We found seven original articles, including six with an impact on predicting RTW. We found four fair and three poor original studies fulfilling our criteria. We found the Back Performance Scale (BPS) and back endurance test to be the most promising tests for occupational health service and the clinical practitioner. Radiation of back pain, with or without neurological deficiencies, had some predictive value in terms of RTW, too. The working conditions vary a lot, which causes inconsistency in the studies and in their interpretation. Functional tests could complete the widely used working ability evaluations methods such as the Work Ability Index (WAI) and are worth considering for future research. Overall, more research is needed in this field. The question of when LBP patients can resume everyday activities and work is not possible to determine with functional tests alone. Psychosocial aspects and work demands must be considered. PROSPERO: CRD42022353955. The study was funded by the University of Helsinki.

Obese people benefit from lumbar spinal stenosis surgery as much as people of normal weight.

BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative condition of the spine that causes back pain radiating to the lower extremity. Surgical treatment is indicated to treat progressive radical symptoms. Obesity has been associated with inferior results in the domains of quality of life (QoL) following an LSS operation, but the research findings have been limited. This paper aims to identify whether obesity affects QoL due to back pain among patients who underwent an operation for LSS. METHODS: This study is based on a series of patients operated on for LSS between 2012 and 2018. Operated patients who returned for follow-up forms within the first or second years were included. A total of 359 patients were selected, 163 males (45%) and 196 females (55%). The mean age was 68.9 years. The EuroQol five-dimension scale (EQ-5D) questionnaire was chosen to measure QoL and the Oswestry Disability Index (ODI) for functional disability. RESULTS: QoL, as measured by EQ-5D, was preoperatively lower in those patients with a BMI ≥ 30. One year after the operation, all groups had a similar trend of improved QoL. At the second year, the results in all groups levelled off even though there was no statistical difference in clinical outcomes (p = 0.92). The ODI was preoperatively statistically higher in patients with a BMI ≥ 30 (p < 0.001). Two years after the surgery, all groups had improved ODI scores, but there was no statistical difference in ODI between the BMI groups (p = 0.54). CONCLUSION: Surgical intervention for debilitating or longstanding symptoms of LSS should be considered as a treatment option for suitable patients in spite of an elevated BMI.

Radiofrequency denervation for chronic low back pain.

BACKGROUND: Radiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness. OBJECTIVES: The objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, three other databases, two clinical trials registries and the reference lists of included studies from inception to May 2014 for randomised controlled trials (RCTs) fulfilling the inclusion criteria. We updated this search in June 2015, but we have not yet incorporated these results. SELECTION CRITERIA: We included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions. DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected RCTs, extracted data and assessed risk of bias (RoB) and clinical relevance using standardised forms. We performed meta-analyses with clinically homogeneous studies and assessed the quality of evidence for each outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: In total, we included 23 RCTs (N = 1309), 13 of which (56%) had low RoB. We included both men and women with a mean age of 50.6 years. We assessed the overall quality of the evidence as very low to moderate. Twelve studies examined suspected facet joint pain, five studies disc pain, two studies SI joint pain, two studies radicular CLBP, one study suspected radiating low back pain and one study CLBP with or without suspected radiation. Overall, moderate evidence suggests that facet joint RF denervation has a greater effect on pain compared with placebo over the short term (mean difference (MD) -1.47, 95% confidence interval (CI) -2.28 to -0.67). Low-quality evidence indicates that facet joint RF denervation is more effective than placebo for function over the short term (MD -5.53, 95% CI -8.66 to -2.40) and over the long term (MD -3.70, 95% CI -6.94 to -0.47). Evidence of very low to low quality shows that facet joint RF denervation is more effective for pain than steroid injections over the short (MD -2.23, 95% CI -2.38 to -2.08), intermediate (MD -2.13, 95% CI -3.45 to -0.81), and long term (MD -2.65, 95% CI -3.43 to -1.88). RF denervation used for disc pain produces conflicting results, with no effects for RF denervation compared with placebo over the short and intermediate term, and small effects for RF denervation over the long term for pain relief (MD -1.63, 95% CI -2.58 to -0.68) and improved function (MD -6.75, 95% CI -13.42 to -0.09). Lack of evidence of short-term effectiveness undermines the clinical plausibility of intermediate-term or long-term effectiveness. When RF denervation is used for SI joint pain, low-quality evidence reveals no differences from placebo in effects on pain (MD -2.12, 95% CI -5.45 to 1.21) and function (MD -14.06, 95% CI -30.42 to 2.30) over the short term, and one study shows a small effect on both pain and function over the intermediate term. RF denervation is an invasive procedure that can cause a variety of complications. The quality and size of original studies were inadequate to permit assessment of how often complications occur. AUTHORS' CONCLUSIONS: The review authors found no high-quality evidence suggesting that RF denervation provides pain relief for patients with CLBP. Similarly, we identified no convincing evidence to show that this treatment improves function. Overall, the current evidence for RF denervation for CLBP is very low to moderate in quality; high-quality evidence is lacking. High-quality RCTs with larger patient samples are needed, as are data on long-term effects.

Finnish version of the Tampa Scale of Kinesiophobia: Reference values in the Finnish general population and associations with leisure-time physical activity.

OBJECTIVES: To create reference values for the general Finnish population using the Tampa Scale of Kinesiophobia (TSK-FIN), to study gender differences in the TSK-FIN, to assess the internal consistency of the TSK-FIN, to estimate the prevalence of high levels of kinesiophobia in Finnish men and women, and to examine the association between kinesiophobia and leisure-time physical activity and the impact of co-morbidities on kinesiophobia. METHODS: The study population comprised 455 men and 579 women. Participants completed a self-administered questionnaire about their socio-demographic factors, leisure-time physical activity, co-morbidities and kinesiophobia. RESULTS: The mean TSK-FIN score was significantly higher for men (mean 34.2, standard deviation (SD) 6.9) compared with women (mean 32.9, SD 6.5), with an age-adjusted p = 0.004 for the difference between men and women. Cronbach's alpha was 0.72, indicating substantial internal consistency. Men over 55 years of age and women over 65 years of age had a higher (p < 0.001) TSK score compared with younger people. There was a significant (p < 0.001) inverse association between kinesiophobia and leisure-time physical activity among both sexes. The presence of cardiovascular disease, musculoskeletal disease or a mental disorder was associated with a higher TSK-FIN score compared with the absence of the aforementioned disorders. CONCLUSION: We present here the reference values for the TSK-FIN. The reference values and prevalence among the general population may help clinicians to define the level of kinesiophobia among patients. Disorders other than musculoskeletal diseases were associated with kinesiophobia, which should be noted in daily practice.

Health-related quality of life and socioeconomic situation among diastrophic dysplasia patients in Finland.

OBJECTIVE: The purpose of the present study was to gain a comprehensive view of the quality of life and socio-economic conditions in a more representative sample of patients with diastrophic dysplasia than previously presented. METHODS: The study sample comprised 115 patients with diastrophic dysplasia, aged over 18 years. The patients were contacted, and 68 patients (59%) agreed to participate in the study. They answered a structured questionnaire, which included the items of RAND-36 and Finn-Health Assessment Questionnaire (Finn-HAQ) questionnaires. The Finn-HAQ items were linked to the categories of the International Classification of Functioning, Disability and Health (ICF). Population controls for matching the participating patients for age and sex were identified in the Finnish population registry. Demographic and social factors (educational status, employment status and household income) were collected in separated questions. RESULTS: RAND-36 showed significantly lower physical functioning in the group of diastrophic dysplasia patients than in the control group. Also, the differences in scores for energy and social functioning were significant. In the mental component scales, no significant difference was found between the groups. When compared with the controls, we found significantly lower levels in all 3 ICF components of functioning in the group of patients when Finn-MDHAQ items linked to ICF were used. Almost 75% of patients with diastrophic dysplasia belonged to the group of people with minor/low income. Some or clear worsening of economic situation due to diastrophic dysplasia was reported by 25 (58%) female and 17 (68%) male patients. CONCLUSION: In their daily living, patients with diastrophic dysplasia have marked physical difficulties, which affect their quality of life, participation in society and their financial situation. It seems that the mental situation is not greatly affected, but a more detailed study is needed to evaluate and illuminate the psychological consequences of this severe skeletal dysplasia. Overall, the pieces of information in the present study are of high importance when designing and reorganizing rehabilitation and in supportive therapy and treatment of patients with diastrophic dysplasia.

Anxiety and depression are independent predictors of quality of life of patients with chronic musculoskeletal pain.

We examined the relative impact of baseline anxiety, depression and fear of movement on health related quality of life at 12-month follow-up after a multidisciplinary pain management programme. One hundred and eleven patients who had chronic musculoskeletal pain (mean age 45 years, 65% women) attended during 2003-2005 a multidisciplinary three-phase pain management programme with a total time frame of six to seven months, totalling 19 days. The Beck Anxiety Inventory was used to rate anxiety, the Beck Depression Inventory depression, the Tampa Scale of Kinesiophobia fear of movement. The generic 15D questionnaire was used to assess health related quality of life. Baseline data were collected at admission, follow-up data at 12 months. Mean health related quality of life increased significantly from baseline to 12-month follow-up. Anxiety at baseline predicted significant negative change in the health related quality of life, depression predicted significant positive change in the health related quality of life. Fear of movement did not predict any significant change in the health related quality of life. We concluded that patients with chronic musculoskeletal pain and mild to moderate depression benefit from a multidisciplinary pain management programme in contrast to anxious patients. The findings imply further research with bigger sample sizes, other than HRQoL outcome measures as well as with other groups of patients.

Association of fear of movement and leisure-time physical activity among patients with chronic pain.

OBJECTIVE: The aim of this study was to clarify the association of fear of movement and physical activity among patients with chronic musculoskeletal pain. METHODS: The sample comprised 93 patients participating in a multidisciplinary pain management programme. The purpose of the programme was to regain overall functioning by means of physical and functional exercises, education and personal pain management training. Tampa Scale of Kinesio-phobia and Leisure Time Physical Activity questionnaires were completed at baseline, and at 6-month and 12-month follow-ups. RESULTS: At baseline, low and medium kinesiophobia groups showed more leisure-time physical activity than did the high kinesiophobia group (p = 0.024). At a 6-month follow-up the high kinesiophobia group had increased their physical activity index to the level of the low and medium kinesiophobia groups and maintained that change to 12-month follow-up. The effect sizes of the change in the physical activity index and pain intensity at the 12-month follow-up were both moderate (0.56) in the high kinesiophobia group. CONCLUSION: The change in physical activity and kinesiophobia was associated with the level of baseline kinesiophobia. Multidisciplinary rehabilitation seems to produce favourable effects in terms of physical activity and pain among the high kinesiophobia patients.

Long-term results of surgery for lumbar spinal stenosis: a randomised controlled trial.

We randomised a total of 94 patients with long-standing moderate lumbar spinal stenosis (LSS) into a surgical group and a non-operative group, with 50 and 44 patients, respectively. The operative treatment comprised undercutting laminectomy of stenotic segments, augmented with transpedicular-instrumented fusion in suspected lumbar instability. The primary outcome was the Oswestry disability index (ODI), and the other main outcomes included assessments of leg and back pain and self-reported walking ability, all based on questionnaire data from 85 patients at the 6-year follow-up. At the 6-year follow-up, the mean difference in ODI in favour of surgery was 9.5 (95% confidence interval 0.9-18.1, P-value for global difference 0.006), whereas the intensity of leg or back pain did not differ between the two treatment groups any longer. Walking ability did not differ between the treatment groups at any time. Decompressive surgery of LSS provided modest but consistent improvement in functional ability, surpassing that obtained after non-operative measures.

WITHDRAWN: Biopsychosocial rehabilitation for upper limb repetitive strain injuries in working age adults.

BACKGROUND: Upper limb repetitive strain injury is a common problem in western countries, causing human suffering and huge economical losses. Patients with prolonged pain associated with repetitive tasks in the work place can face both psychological and physical difficulties. Different treatment programmes, physical, psychological, behavioural , social and occupational treatments have been developed and used to help these patients. OBJECTIVES: The objective of this systematic review is to determine the effectiveness of biopsychosocial rehabilitation for upper limb repetitive strain injuries among working age adults. SEARCH STRATEGY: The reviewed studies for this structured Cochrane review were identified from electronic bibliographic databases, the Science Citation Index, reference checking and consulting experts in the rehabilitation field. The original search was planned and performed for a more broad area of musculoskeletal disorders. Trials on repetitive strain injuries were separated afterwards. SELECTION CRITERIA: Randomised controlled trials and controlled trials comparing biopsychosocial measures for the treatment of repetitive upper limb strain injury in working age adults DATA COLLECTION AND ANALYSIS: Two experts in the field of rehabilitation evaluated the clinical relevance and applicability of the findings of the selected studies to actual clinical use. Two other blinded reviewers extracted the data and assessed the main results and the methodological quality of the studies using standardized forms. Finally, a qualitative analysis was performed to evaluate the level of scientific evidence for the effectiveness of biopsychosocial rehabilitation. MAIN RESULTS: We found only two relevant studies that satisfied our criteria. They assessed the effectiveness of two specific interventions and were both considered as low quality trials. The clinical relevance of the included studies was also unsatisfactory. The level of scientific evidence for the effectiveness of biopsychosocial rehabilitation for repetitive strain injuries was limited. One small trial found that hypnosis supplementary to comprehensive treatment can decrease the intensity of pain for acute RSI in six weeks follow-up. AUTHORS' CONCLUSIONS: We conclude that presently there appears to be little scientific evidence for the effectiveness of biopsychosocial rehabilitation on repetitive strain injuries. As RCTs on more intensive and comprehensive biopsychosocial treatment programmes for RSI are lacking, there does not seem to be reliable data for these interventions. There is a need for high quality trials in this field.

Perceived disability but not pain is connected with autonomic nervous function among patients with chronic low back pain.

OBJECTIVE: To assess the association of cardiovascular autonomic balance with perceived functional impairment and pain among patients with chronic low back pain. DESIGN: A cross-sectional analysis of working patients with chronic low back pain. PATIENTS: Forty-six consecutive patients aged 24-45 years with chronic low back pain fulfilling the inclusion criteria. A total of 39 subjects had technically acceptable electrocardiographic recordings during periods of rest and standard provocations. METHODS: Perceived functional disability was assessed with the Oswestry disability index and pain with a numerical rating scale. Autonomic nervous function was assessed by measuring heart rate variability with short recordings. RESULTS: The total power of heart rate variability was lower among those with moderate perceived disability (Oswestry 20-40%) compared with those with minimal disability (Oswestry < 20%). However, heart rate variability did not differ significantly among those with numerical rating scale values < or = 5/10 from those with values > 5/10. The power of the high-frequency component (0.15-0.4 Hz) of heart rate variability was lower among those with moderate perceived functional impairment. CONCLUSION: A significant association existed between heart rate variability and perceived physical impairment, but not between heart rate variability and pain. Proportionally reduced high-frequency activity was found to reflect decreased parasympathetic activity or increased sympathetic activity. This resulted in sympathetic dominance among the patients with higher subjective disability. The possible clinical implications of this observation are discussed.

Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis. METHODS: Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months. RESULTS: Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups. CONCLUSIONS: Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.

The treatment of disc-herniation-induced sciatica with infliximab: one-year follow-up results of FIRST II, a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To evaluate the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha), in patients with acute/subacute sciatica secondary to herniated disc. SUMMARY OF BACKGROUND DATA: The results of experimental studies and our open-label trial support the use of infliximab in sciatica. Here we report the 1-year results of a randomized controlled trial (FIRST II, Finnish Infliximab Related STudy) evaluating the efficacy and safety of a single infusion of infliximab for sciatic pain. METHODS: Inclusion criteria were unilateral sciatic pain with a disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy. Criteria for discectomy included (in addition to a symptomatic disc herniation on MRI) neural entrapment (straight leg raising [SLR] < or =60 degrees ) with either a short-term (2-4 weeks) severe or long-term (4-12 weeks) moderate leg pain. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Differences in the clinical examination parameters (straight leg raise [SLR], muscle strength, sensory defects, tendon reflexes), patient-reported symptoms (leg and back pain using a visual analog scale [VAS], Oswestry disability, quality-of-life [RAND-36]), sick leaves, number of discectomies, and adverse effects between the two treatment groups over the 1-year follow-up were compared using Mann-Whitney U test or Student's t test, repeated-measures analysis, or Cox proportional hazards model. Logistic regression was used to assess the predictors of good response. RESULTS: Sixty-seven percent of patients in the infliximab group reported no pain at 52 weeks compared with 63% in the control group (P = 0.72). Similar efficacy was observed between treatment groups for other outcomes. Eight patients in each group required surgery. Three nonserious adverse reactions were encountered in the infliximab group. The response (irrespective of the treatment) was significantly better with shorter symptom duration and less SLR restriction at baseline. Patients in the infliximab group appeared to especially benefit in cases of a L4-L5 (or L3-L4) herniation and if a Modic change was colocalized at the symptomatic level. CONCLUSIONS: Although the long-term results of this randomized trial do not support the use of infliximab compared with placebo for lumbar radicular pain in patients with disc herniation-induced sciatica, further study in a subgroup of patients with L4-L5 or L3-L4 herniations, especially in the presence of Modic changes, appears to be warranted.

The effect of infliximab, a monoclonal antibody against TNF-alpha, on disc herniation resorption: a randomized controlled study.

STUDY DESIGN: Randomized, controlled study. OBJECTIVE: To evaluate the effect of infliximab on herniated nucleus pulposus (HNP) resorption. SUMMARY OF BACKGROUND DATA: Although the effects of tumor necrosis factor alpha (TNF-alpha) on HNP resorption are not fully understood, TNF-alpha appears to be an essential mediator in HNP resorption. METHODS: As part of a substudy of the FIRST II study, magnetic resonance images (MRIs) were obtained from 21 patients who were candidates for discectomy at weeks 0, 2, 12, and 26 after receiving a single infusion of either 5 mg/kg infliximab (11 patients) or placebo (10 patients). The volume (mm3) of HNP, thickness (mm) and extent (%) of rim enhancement, and presence of nerve root edema were assessed. RESULTS: HNP volume decreased significantly from baseline to 6 months in both treatment groups (P < 0.01), with no difference noted between the infliximab and placebo groups. By week 2, rim enhancement thickness increased significantly in the infliximab group compared with the placebo group (P = 0.003). Two patients in each group required back surgery before the 6-month assessment. CONCLUSIONS: Infliximab did not appear to interfere with disc herniation resorption over a 6-month period.

Self-reported and test-based mobility limitations in a representative sample of Finns aged 30+.

AIMS: The object of the present study was to acquire a comprehensive and accurate picture of mobility limitations in the Finnish adult population. METHODS: A nationally representative sample of 8,028 persons aged 30+ with high participation was interviewed and examined in the Health 2000 Survey conducted in 2000-01. Mobility limitations were measured by self-reports and performance tests. RESULTS: Perceived running difficulties were already common among persons in middle age, while difficulties in moving about indoors were frequent only among persons aged 75+. A third of women and a fifth of men aged 55+ could not reach a walking speed of 1.2 m/s. Working-aged women were more limited than men only in physically demanding tasks, but in the elderly the gender difference was evident in most mobility tasks. A substantial disagreement was found between the self-reported and test-based indicators in stair climbing. Supplementary data collection, carried out to increase participation in the health examination, as well as inclusion of institutionalized persons, provided a more complete estimate of the prevalence of mobility limitations among the elderly. CONCLUSIONS: Both self-reported and performance-based indicators are needed to achieve a comprehensive view of disability and its variation between population groups. Exclusion of institutionalized persons and low participation lead to underestimation of the occurrence of limitations. The number of persons suffering from mobility problems will increase with ageing of the population, which accentuates the importance of early intervention to maintain functional ability, especially in women.

The treatment of disc herniation-induced sciatica with infliximab: results of a randomized, controlled, 3-month follow-up study.

STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. SUMMARY OF BACKGROUND DATA: Recently, we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica. Furthermore, the results of experimental studies support the use of infliximab in sciatica. Therefore, we initiated a randomized, controlled trial (FIRST II, Finnish Infliximab Related STudy) to confirm the efficacy of a single infusion of infliximab for sciatic pain. METHODS: Inclusion criteria were unilateral moderate to severe sciatic pain with an MRI-confirmed disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy, as evaluated by an independent orthopedic surgeon. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Assessments at baseline and various time points included clinical examination with measurement of straight leg raising restriction; questionnaires related to subjective symptoms (leg and back pain by 100-mm visual analog scale, Oswestry disability); sick leaves; number of discectomies; and adverse effects possibly related to treatment. The primary endpoint was a reduction in leg pain from baseline to 12 weeks, which was analyzed using a Mann-Whitney U test and repeated-measures analysis. RESULTS: A significant reduction in leg pain was observed in both groups, with no significant difference between treatment regimens. Similar efficacy was observed between treatment groups for secondary endpoints. Seven patients in each group required surgery. No adverse effects related to treatment were encountered. CONCLUSIONS: The results of this randomized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica.

Psychosocial differences as predictors for recovery from chronic low back pain following manipulation, stabilizing exercises and physician consultation or physician consultation alone.

OBJECTIVE: Three psychosocial profile groups are introduced in the Multidimensional Pain Inventory for chronic pain patients. Patients with the dysfunctional profile have shown a more favourable outcome after multidisciplinary treatments, due to the suggested effects of specific psychosocial treatment elements. In this study we explored, among patients with chronic low back pain, whether the Multidimensional Pain Inventory patient profile groups might respond differently to treatment without planned psychosocial elements. METHODS: Of 204 voluntarily recruited patients with chronic low back pain, 102 were randomized to a combined manipulation, exercise and physician consultation group (called the combination group) and 102 to a consultation-alone group. RESULTS: Although all subjects showed improvement during follow-up both on the Oswestry index and the Visual Analogue Scale, the dysfunctional profile patients in the combination group improved the most. Their high pre-treatment ratings on Oswestry and Visual Analogue-scales fell at the 5- and 12-month follow-ups to the same level as those of the adaptive copers or interpersonally distressed patients, and they were on a significantly lower level than the dysfunctional profile patients in consultation group during follow-up. All dysfunctional profile patients also showed a decrease in affective distress, equally in combination and consultation groups. CONCLUSION: We suggest that dysfunctional profile patients are more sensitive to respond even to treatment without any specific psychosocial elements. This should be considered when evaluating any treatment effects. Among dysfunctional profile patients, pain-related anxiety and decreased acceptance of pain may contribute to their sensitivity to treatment.

Cost-effectiveness of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain: a prospective randomized trial with 2-year follow-up.

STUDY DESIGN: A prospective, randomized controlled trial. OBJECTIVE: To examine long-term effects and costs of combined manipulative treatment, stabilizing exercises, and physician consultation compared with physician consultation alone for chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: An obvious gap exists in knowledge concerning long-term efficacy and cost-effectiveness of manipulative treatment methods. METHODS: Of 204 patients with cLBP whose Oswestry Disability Index (ODI) was at least 16%, 102 were randomized into a combined manipulative treatment, exercise, and physician consultation group (i.e., a combination group), and 102 to a consultation alone group. All patients were clinically examined, informed about their back pain, and encouraged to stay active and exercise according to specific instructions based on clinical evaluation. Treatment included 4 sessions of manual therapy and stabilizing exercises aimed at correcting the lumbopelvic rhythm. Questionnaires inquired about pain (visual analog scale (VAS)), disability (ODI), health-related quality of life (15D Quality of Life Instrument), satisfaction with care, and costs. RESULTS: Significant improvement occurred in both groups on every self-rated outcome measurement. Within 2 years, the combination group showed only a slightly more significant reduction in VAS (P = 0.01, analysis of variance) but clearly higher patient satisfaction (P = 0.001, Pearson chi2) as compared to the consultation group. Incremental analysis showed that for combined group compared to consultation group, a one-point change in VAS scale cost $512. CONCLUSIONS: Physician consultation alone was more cost-effective for both health care use and work absenteeism, and led to equal improvement in disability and health-related quality of life. It seems obvious that encouraging information and advice are major elements for the treatment of patients with cLBP.