SpineData – A Danish clinical registry of people with chronic back pain

Background: Large-scale clinical registries are increasingly recognized as important resources for quality assurance and research to inform clinical decision-making and health policy. We established a clinical registry (SpineData) in a conservative care setting where more than 10,000 new cases of spinal pain are assessed each year. This paper describes the SpineData registry, summarizes the characteristics of its clinical population and data, and signals the availability of these data as a resource for collaborative research projects. Methods: The SpineData registry is an Internet-based system that captures patient data electronically at the point of clinical contact. The setting is the government-funded Medical Department of the Spine Centre of Southern Denmark, Hospital Lillebaelt, where patients receive a multidisciplinary assessment of their chronic spinal pain. Results: Started in 2011, the database by early 2015 contained information on more than 36,300 baseline episodes of patient care, plus the available 6-month and 12-month follow-up data for these episodes. The baseline questionnaire completion rate has been 93%; 79% of people were presenting with low back pain as their main complaint, 6% with mid-back pain, and 15% with neck pain. Collectively, across the body regions and measurement time points, there are approximately 1,980 patient-related variables in the database across a broad range of biopsychosocial factors. To date, 36 research projects have used data from the SpineData registry, including collaborations with researchers from Denmark, Australia, the United Kingdom, and Brazil. Conclusion: We described the aims, development, structure, and content of the SpineData registry, and what is known about any attrition bias and cluster effects in the data. For epidemiology research, these data can be linked, at an individual patient level, to the Danish population-based registries and the national spinal surgery registry. SpineData also has potential for the conduct of cohort multiple randomized controlled trials. Collaborations with other researchers are welcome

Nordic Walking and chronic low back pain: design of a randomized clinical trial

BACKGROUND: Low Back Pain is a major public health problem all over the western world. Active approaches including exercise in the treatment of low back pain results in better outcomes for patients, but it is not known exactly which types of back exercises are most beneficial or whether general physical activity provide similar benefits. Nordic Walking is a popular and fast growing type of exercise in Northern Europe. Initial studies have demonstrated that persons performing Nordic Walking are able to exercise longer and harder compared to normal walking thereby increasing their cardiovascular metabolism. Until now no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to low back pain. The primary aim of this study is to investigate whether supervised Nordic Walking can reduce pain and improve function in a population of chronic low back pain patients when compared to unsupervised Nordic Walking and advice to stay active. In addition we investigate whether there is an increase in the cardiovascular metabolism in persons performing supervised Nordic Walking compared to persons who are advised to stay active. Finally, we investigate whether there is a difference in compliance between persons receiving supervised Nordic Walking and persons doing unsupervised Nordic Walking. METHODS: One hundred and fifty patients with low back pain for at least eight weeks and referred to a specialized secondary sector outpatient back pain clinic are included in the study. After completion of the standard back centre treatment patients are randomized into one of three groups: A) Nordic Walking twice a week for eight weeks under supervision of a specially trained instructor; B) Unsupervised Nordic Walking for eight weeks after one training session with an instructor; C) A one hour motivational talk including advice to stay active. Outcome measures are pain, function, overall health, cardiovascular ability and activity level. RESULTS: No results available at this point. DISCUSSION: This study will investigate the effect of Nordic Walking on pain and function in a population of people with chronic LBP. TRIAL REGISTRATION: registration # NCT0020982

Routine versus needs-based MRI in patients with prolonged low back pain: a comparison of duration of treatment, number of clinical contacts and referrals to surgery

<p>Abstract</p> <p>Background</p> <p>The routine use of radiology is normally discouraged in patients with low back pain (LBP). Magnetic Resonance Imaging (MRI) provides clinicians and patients with detailed knowledge of spinal structures and has no known physical side effects. It is possible that insight into the pathological changes in LBP patients could affect patient management. However, to our knowledge, this has never been tested. Until June 2006, all patients at our specialised out-patient public clinic were referred for MRI on the basis of clinical indications, economic constraints, and availability of MRI (the "needs-based MRI" group). As a new approach, we now refer all patients who meet certain criteria for routine up-front MRI before the clinical examination (the "routine MRI" group).</p> <p>Objectives</p> <p>The aims of this study were to investigate if these two MRI approaches resulted in differences in: (1) duration of treatment, (2) number of contacts with clinicians, and (3) referral for surgery.</p> <p>Design</p> <p>Comparison of two retrospective clinical cohorts.</p> <p>Method</p> <p>Files were retrieved from consecutive patients in both groups. Criteria for referral were: (1) LBP or leg pain of at least 3 on an 11-point Numeric Rating Scale, (2) duration of present symptoms from 2 to12 months and (3) age above 18 years. A comparison was made between the "needs-based MRI" and "routine MRI" groups on the outcomes of duration of treatment and use of resources.</p> <p>Results</p> <p>In all, 169 "needs-based MRI" and 208 "routine MRI" patient files were identified. The two groups were similar in age, sex, and severity of LBP. However, the median duration of treatment for the "needs-based MRI" group was 160 versus 115 days in the "routine MRI" group (p = 0.0001). The median number of contacts with clinicians for the "needs-based MRI" group was 4 versus 3 for the "routine MRI" group (p = 0.003). There was no difference between the two approaches in frequency of referral for back surgery (p = 0.81). When the direct clinical costs were compared, the "routine MRI" group was less costly but only by €11.</p> <p>Conclusion</p> <p>In our clinic, the management strategy of routinely performing an up-front MRI at the start of treatment did reduce the duration of treatment and number of contacts with clinicians, and did not increase the rate of referral for back surgery. Also, the direct costs were not increased.</p

Supervised and non-supervised Nordic walking in the treatment of chronic low back pain: a single blind randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Active approaches including both specific and unspecific exercise are probably the most widely recommended treatment for patients with chronic low back pain but it is not known exactly which types of exercise provide the most benefit. Nordic Walking - power walking using ski poles - is a popular and fast growing type of exercise in Northern Europe that has been shown to improve cardiovascular metabolism. Until now, no studies have been performed to investigate whether Nordic Walking has beneficial effects in relation to back pain.</p> <p>Methods</p> <p>A total of 151 patients with low back and/or leg pain of greater than eight weeks duration were recruited from a hospital based outpatient back pain clinic. Patients continuing to have pain greater than three on the 11-point numeric rating scale after a multidisciplinary intervention were included. Fifteen patients were unable to complete the baseline evaluation and 136 patients were randomized to receive A) Nordic walking supervised by a specially trained instructor twice a week for eight weeks B) One-hour instruction in Nordic walking by a specially trained instructor followed by advice to perform Nordic walking at home as much as they liked for eight weeks or C) Individual oral information consisting of advice to remain active and about maintaining the daily function level that they had achieved during their stay at the backcenter. Primary outcome measures were pain and disability using the Low Back Pain Rating Scale, and functional limitation further assessed using the Patient Specific Function Scale. Furthermore, information on time off work, use of medication, and concurrent treatment for their low back pain was collected. Objective measurements of physical activity levels for the supervised and unsupervised Nordic walking groups were performed using accelerometers. Data were analyzed on an intention-to-treat basis.</p> <p>Results</p> <p>No mean differences were found between the three groups in relation to any of the outcomes at baseline. For pain, disability, and patient specific function the supervised Nordic walking group generally faired best however no statistically significant differences were found. Regarding the secondary outcome measures, patients in the supervised group tended to use less pain medication, to seek less concurrent care for their back pain, at the eight-week follow-up. There was no difference between physical activity levels for the supervised and unsupervised Nordic walking groups. No negative side effects were reported.</p> <p>Conclusion</p> <p>We did not find statistically significant differences between eight weeks of supervised or unsupervised Nordic walking and advice to remain active in a group of chronic low back pain patients. Nevertheless, the greatest average improvement tended to favor the supervised Nordic walking group and - taking into account other health related benefits of Nordic walking - this form of exercise may potentially be of benefit to selected groups of chronic back pain patients.</p> <p>Trial registration</p> <p><url>http://www.ClinicalTrials.gov</url> # NCT00209820</p

Prognostic implications of the Quebec Task Force classification of back-related leg pain: An analysis of longitudinal routine clinical data

Background: Low back pain (LBP) patients with related leg pain have a more severe profile than those with local LBP and a worse prognosis. Pain location above or below the knee and the presence of neurological signs differentiate patients with different profiles, but knowledge about the prognostic value of these subgroups is sparse. The objectives of this study were (1) to investigate whether subgroups consisting of patients with Local LBP only, LBP + leg pain above the knee, LBP + leg pain below the knee, and LBP + leg pain and neurological signs had different prognoses, and (2) to determine if this was explained by measured baseline factors. Methods. Routine clinical data were collected during the first visit to an outpatient department and follow-ups were performed after 3 and 12 months. Patients were divided into the four subgroups and associations between subgroups and the outcomes of activity limitation, global perceived effect (GPE) after 3 months, and sick leave after 3 months were tested by means of generalised estimating equations. Models were univariate (I), adjusted for duration (II), and adjusted for all baseline differences (III). Results: A total of 1,752 patients were included, with a 76% 3-month and 70% 12-month follow-up. Subgroups were associated with activity limitation in all models (p &lt; 0.001). Local LBP had the least and LBP + neurological signs the most severe limitations at all time-points, although patients with neurological signs improved the most. Associations with GPE after 3 months were only significant in Model I. Subgroups were associated with sick leave after 3 months in model I and II, with sick leave being most frequent in the subgroup with neurological signs. No significant differences were found in any pairwise comparisons of patients with leg pain above or below the knee. Conclusions: Subgrouping LBP patients, based on pain location and neurological signs, was associated with activity limitation and sick leave, but not with GPE. The presence of neurological signs and pain in the leg both have prognostic implications but whether that leg pain without neurological signs is above or below the knee does not

Patients with low back pain differ from those who also have leg pain or signs of nerve root involvement - A cross-sectional study

Background: Leg pain associated with low back pain (LBP) is recognized as a risk factor for a poor prognosis, and is included as a component in most LBP classification systems. The location of leg pain relative to the knee and the presence of a positive straight leg raise test have been suggested to have clinical implications. To understand differences between such leg pain subgroups, and whether differences include potentially modifiable characteristics, the purpose of this paper was to describe characteristics of patients classified into the Quebec Task Force (QTF) subgroups of: 1) LBP only, 2) LBP and pain above the knee, 3) LBP and pain below the knee, and 4) LBP and signs of nerve root involvement. Methods. Analysis of routine clinical data from an outpatient department. Based on patient reported data and clinical findings, patients were allocated to the QTF subgroups and described according to the domains of pain, activity limitation, work participation, psychology, general health and clinical examination findings. Results: A total of 2,673 patients aged 18-95 years (median 47) who were referred for assessment of LBP were included. Increasing severity was consistently observed across the subgroups from LBP only to LBP with signs of nerve root involvement although subgroup differences were small. LBP patients with leg pain differed from those with LBP only on a wide variety of parameters, and patients with signs of nerve root involvement had a more severe profile on almost all measures compared with other patients with back-related leg pain. Conclusion: LBP patients with pain referral to the legs were more severely affected than those with local LBP, and patients with signs of nerve root involvement were the ones most severily affected. These findings underpin the concurrent validity of the Quebec Task Force Classification. However, the small size of many between-subgroup differences amid the large variability in this sample of cross-sectional data also underlines that the heterogeneity of patients with LBP is more complex than that which can be explained by leg pain patterns alone. The implications of the observed differences also require investigation in longitudinal studies

The immediate and long-term effects of exercise and patient education on physical, functional, and quality-of-life outcome measures after single-level lumbar microdiscectomy: a randomized controlled trial protocol

BACKGROUND: Low back pain remains a costly quality-of-life-related health problem. Microdiscectomy is often the surgical procedure of choice for a symptomatic, single-level, lumbar disc herniation in younger and middle-aged adults. The question of whether a post-microdiscectomy exercise program enhances function, quality of life, and disability status has not been systematically explored. Thus, the overall purpose of this study is to assess immediate and long-term outcomes of an exercise program, developed at University of Southern California (USC), targeting the trunk and lower extremities (USC Spine Exercise Program) for persons who have undergone a single-level microdiscectomy for the first time. METHODS/DESIGN: One hundred individuals between the ages of 18 and 60 who consent to undergo lumbar microdiscectomy will be recruited to participate in this study. Subjects will be randomly assigned to one of two groups: 1) one session of back care education, or 2) a back care education session followed by the 12-week USC Spine Exercise Program. The outcome examiners (evaluators), as well as the data managers, will be blinded to group allocation. Education will consist of a one-hour "one-on-one" session with the intervention therapist, guided by an educational booklet specifically designed for post-microdiscectomy care. This session will occur four to six weeks after surgery. The USC Spine Exercise Program consists of two parts: back extensor strength and endurance, and mat and upright therapeutic exercises. This exercise program is goal-oriented, performance-based, and periodized. It will begin two to three days after the education session, and will occur three times a week for 12 weeks. Primary outcome measures include the Oswestry Disability Questionnaire, Roland-Morris Disability Questionnaire, SF-36(® )quality of life assessment, Subjective Quality of Life Scale, 50-foot Walk, Repeated Sit-to-Stand, and a modified Sorensen test. The outcome measures in the study will be assessed before and after the 12-week post-surgical intervention program. Long-term follow up assessments will occur every six months beginning one year after surgery and ending five years after surgery. Immediate and long-term effects will be assessed using repeated measures multivariate analysis of variance (MANOVA). If significant interactions are found, one-way ANOVAs will be performed followed by post-hoc testing to determine statistically significant pairwise comparisons. DISCUSSION: We have presented the rationale and design for a randomized controlled trial evaluating the effectiveness of a treatment regimen for people who have undergone a single-level lumbar microdiscectomy

Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with nonspecific low back pain [ISRCTN19334317]

BACKGROUND: Researchers from the Royal Netherlands Army are studying the potential of isolated lumbar extensor training in low back pain in their working population. Currently, a randomized controlled trial is carried out in five military health centers in The Netherlands and Germany, in which a 10-week program of not more than 2 training sessions (10–15 minutes) per week is studied in soldiers with nonspecific low back pain for more than 4 weeks. The purpose of the study is to investigate the efficacy of this 'minimal intervention program', compared to usual care. Moreover, attempts are made to identify subgroups of different responders to the intervention. METHODS: Besides a baseline measurement, follow-up data are gathered at two short-term intervals (5 and 10 weeks after randomization) and two long-term intervals (6 months and one year after the end of the intervention), respectively. At every test moment, participants fill out a compound questionnaire on a stand-alone PC, and they undergo an isometric back strength measurement on a lower back machine. Primary outcome measures in this study are: self-assessed degree of complaints and degree of handicap in daily activities due to back pain. In addition, our secondary measurements focus on: fear of movement/(re-) injury, mental and social health perception, individual back extension strength, and satisfaction of the patient with the treatment perceived. Finally, we assess a number of potential prognostic factors: demographic and job characteristics, overall health, the degree of physical activity, and the attitudes and beliefs of the physiotherapist towards chronic low back pain. DISCUSSION: Although a substantial number of trials have been conducted that included lumbar extension training in low back pain patients, hardly any study has emphasized a minimal intervention approach comparable to ours. For reasons of time efficiency and patient preferences, this minimal sports medicine approach of low back pain management is interesting for the population under study, and possibly for comparable working populations with physical demanding job activities