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Guideline Chapter 4. European guidelines for the management of chronic nonspecific low back pain. 2006
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G, Anonymous00003. · No affiliation provided · Eur Spine J. · Pubmed #16550448 No free full text.
This publication has no abstract.
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Review Injection therapy for subacute and chronic low back pain: an updated Cochrane review. 2009
Staal JB, de Bie RA, de Vet HC, Hildebrandt J, Nelemans P. · Department of Epidemiology and Caphri Research School, Maastricht University, P Debyeplein 1, Maastricht, Netherlands. · Spine (Phila Pa 1976). · Pubmed #19127161 No free full text.
Abstract: STUDY DESIGN: A systematic review of randomized controlled trials (RCTs). OBJECTIVE: To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low back pain. SUMMARY OF BACKGROUND DATA: The effectiveness of injection therapy for low back pain is still debatable. Heterogeneity of target tissue, pharmacological agent, and dosage, generally found in RCTs, point to the need for clinically valid comparisons in a literature synthesis. METHODS: We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases up to March 2007 for relevant trials reported in English, French, German, Dutch, and Nordic languages. We also screened references from trials identified. RCTs on the effects of injection therapy involving epidural, facet, or local sites for subacute or chronic low back pain were included. Studies that compared the effects of intradiscal injections, prolotherapy, or ozone therapy with other treatments were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. RESULTS: Eighteen trials (1179 participants) were included in this review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender-and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics, and a variety of other drugs. The methodologic quality of the trials was limited with 10 of 18 trials rated as having a high methodologic quality. Statistical pooling was not possible because of clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. CONCLUSION: There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.
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Review Injection therapy for subacute and chronic low-back pain. 2008
Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. · Department of Epidemiology and Caphri Research Institute, Maastricht University , P Debyeplein 1, Maastricht, Netherlands, 6200 MD. · Cochrane Database Syst Rev. · Pubmed #18646078 No free full text.
Abstract: BACKGROUND: The effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis. OBJECTIVES: To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low-back pain. SEARCH STRATEGY: We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE databases from January 1999 to March 2007 for relevant trials reported in English, French, German, Dutch and Nordic languages. We also screened references from trials identified. SELECTION CRITERIA: RCTs on the effects of injection therapy involving epidural, facet or local sites for subacute or chronic low-back pain were included. Studies which compared the effects of intradiscal injections, prolotherapy or Ozone therapy with other treatments, were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the quality of the trials. If study data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a best evidence synthesis to summarize the results. The evidence was classified into five levels (strong, moderate, limited, conflicting or no evidence), taking into account the methodological quality of the studies. MAIN RESULTS: 18 trials (1179 participants) were included in this updated review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender- and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics and a variety of other drugs. The methodological quality of the trials was limited with 10 out of 18 trials rated as having a high methodological quality. Statistical pooling was not possible due to clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.
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Review Physical exercise interventions to improve disability and return to work in low back pain: current insights and opportunities for improvement. 2005
Staal JB, Rainville J, Fritz J, van Mechelen W, Pransky G. · Department of Epidemiology, Maastricht University, 6200 MD, PO Box 616, Maastricht, The Netherlands. · J Occup Rehabil. · Pubmed #16254751 No free full text.
Abstract: INTRODUCTION: There is a body of literature that indicates that physical exercise interventions, with a primary focus on improvement of functioning instead of pain relief, might be effective to stimulate return to work and improve function in workers who are absent from work due to low back pain (LBP). Successful application and implementation of these interventions however, depends on multiple factors that need to be addressed carefully in clinical practice as well as research. METHODS: Descriptive literature review, to identify an overview of current knowledge with respect to the safety, content- and context-related aspects of physical exercise interventions, issues relating to timing, the influence of treatment confidence and patient expectations, and the process of changing provider and employer behavior. RESULTS: Physical exercises are not associated with an increased risk for recurrences. The effects of interventions may vary depending on content-related factors (i.e., type of exercises, dosage, frequency, skills of the healthcare providers, etc.) and contextual factors (i.e., treatment setting, compensation system, etc.). Treatment confidence and patients' expectations also significantly influence outcomes of physical exercise interventions. Timing is also important; interventions targeting return to work, applied during the acute phase of work absenteeism, compete with a high rate of spontaneous recovery and may therefore be inefficient. CONCLUSIONS: Despite numerous studies, more quantitative and qualitative investigations are needed to further clarify the requirements for a successful application and implementation of physical exercise interventions for disabled workers with low back pain.
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Review Effectiveness of a return-to-work intervention for subacute low-back pain. 2005
Hlobil H, Staal JB, Spoelstra M, Ariëns GA, Smid T, van Mechelen W. · Department of Public and Occupational Health, Institute for Research in Extramural Medicine, VU University Medical Centre, Amsterdam, The Netherlands. · Scand J Work Environ Health. · Pubmed #16161707 No free full text.
Abstract: The effectiveness of return-to-work intervention for subacute low-back pain on work absenteeism, pain severity, and functional status was examined by means of a systematic review of randomized controlled trials. Publications in English that met the selection criteria were identified in a computer-aided search and assessed for methodological quality. A best-evidence synthesis was performed instead of statistical data pooling, because of the heterogeneity of the interventions and study populations. Five of nine studies comparing return-to-work intervention with usual care were identified as methodologically high-quality studies. Strong evidence was found for the effectiveness of return to work intervention on the return-to-work rate after 6 months and for the effectiveness of return-to-work intervention on the reduction of days of absence from work after > or = 12 months. It can be concluded that return-to-work interventions are equal or more effective regarding absence from work due to subacute low-back pain than usual care is.
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Review Occupational health guidelines for the management of low back pain: an international comparison. free! 2003
Staal JB, Hlobil H, van Tulder MW, Waddell G, Burton AK, Koes BW, van Mechelen W. · Department of Social Medicine, VU University Medical Centre, 1081 BT Amsterdam, Netherlands. · Occup Environ Med. · Pubmed #12937181 links to free full text
Abstract: BACKGROUND: The enormous socioeconomic burden of low back pain emphasises the need for effective management of this problem, especially in an occupational context. To address this, occupational guidelines have been issued in various countries. AIMS: To compare available international guidelines dealing with the management of low back pain in an occupational health care setting. METHODS: The guidelines were compared regarding generally accepted quality criteria using the AGREE instrument, and also summarised regarding the guideline committee, the presentation, the target group, and assessment and management recommendations (that is, advice, return to work strategy, and treatment). RESULTS: and Conclusions: The results show that the quality criteria were variously met by the guidelines. Common flaws concerned the absence of proper external reviewing in the development process, lack of attention to organisational barriers and cost implications, and lack of information on the extent to which editors and developers were independent. There was general agreement on numerous issues fundamental to occupational health management of back pain. The assessment recommendations consisted of diagnostic triage, screening for "red flags" and neurological problems, and the identification of potential psychosocial and workplace barriers for recovery. The guidelines also agreed on advice that low back pain is a self limiting condition and, importantly, that remaining at work or an early (gradual) return to work, if necessary with modified duties, should be encouraged and supported.
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Clinical Conference Substantial sick-leave costs savings due to a graded activity intervention for workers with non-specific sub-acute low back pain. free! 2007
Hlobil H, Uegaki K, Staal JB, de Bruyne MC, Smid T, van Mechelen W. · KLM Health Services, Postbus 7700 (SPL/AG), 1117 ZL Luchthaven, Schiphol, The Netherlands. · Eur Spine J. · Pubmed #17186282 links to free full text
Abstract: The objective of this study is to compare the costs and benefits of a graded activity (GA) intervention to usual care (UC) for sick-listed workers with non-specific low back pain (LBP). The study is a single-blind, randomized controlled trial with 3-year follow-up. A total of 134 (126 men and 8 women) predominantly blue-collar workers, sick-listed due to LBP were recruited and randomly assigned to either GA (N = 67; mean age 39 +/- 9 years) or to UC (N = 67; mean age 37 +/- 8 years). The main outcome measures were the costs of health care utilization during the first follow-up year and the costs of productivity loss during the second and the third follow-up year. At the end of the first follow-up year an average investment for the GA intervention of 475 euros per worker, only 83 euros more than health care utilization costs in UC group, yielded an average savings of at least 999 euros (95% CI: -1,073; 3,115) due to a reduction in productivity loss. The potential cumulative savings were an average of 1,661 euros (95% CI: -4,154; 6,913) per worker over a 3-year follow-up period. It may be concluded that the GA intervention for non-specific LBP is a cost-beneficial return-to-work intervention.
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Clinical Conference Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with nonspecific low back pain [ISRCTN19334317]. free! 2004
Helmhout PH, Harts CC, Staal JB, de Bie RA. · Department of Training Medicine and Training Physiology, Occupational Health & Safety Service Royal Netherlands Army, P,O, Box 90004, 3509 AA Utrecht, The Netherlands. · BMC Musculoskelet Disord. · Pubmed #15535881 links to free full text
Abstract: 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.
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Clinical Conference Comparison of a high-intensity and a low-intensity lumbar extensor training program as minimal intervention treatment in low back pain: a randomized trial. 2004
Helmhout PH, Harts CC, Staal JB, Candel MJ, de Bie RA. · Department of Training Medicine and Training Physiology, Occupational Health and Safety Service Royal Netherlands Army, LGen Knoopkazerne, Mineurslaan 500, 3521 AG Utrecht, The Netherlands. · Eur Spine J. · Pubmed #15095072 No free full text.
Abstract: In a randomized, observer-blinded trial, the effectiveness of 3-month high-intensity training (HIT) of the isolated lumbar extensors was compared to low-intensity training (LIT). Eighty-one workers with nonspecific low back pain longer than 12 weeks were randomly assigned to either of the two training programs.Training sessions were performed on a modified training device that isolated the lower back extensors. Total intervention time was limited to 5-10 min (one or two training sessions) per week. Training effects were assessed in terms of changes in self-rated degree of back complaints, functional disability, and general, physical and mental health. Secondary outcomes in this study were muscle strength and fear of moving the back (kinesiophobia). Outcomes were evaluated at 1,2, 3, 6, and 9 months after randomization.The results showed that the two treatment programs led to comparable improvements in all outcome measures, except for mean isometric strength at 1, 2, 3, 6, and 9 months and kinesiophobia score at 2 and 9 months of follow-up. The high-intensity training group showed a higher strength gain (24 to 48 Nm) but a smaller decline in kinesiophobia (2.5 and 3.4 points, respectively), compared to the low-intensity training group.It can be concluded that high-intensity training of the isolated back extensors was not superior to a non-progressive, low-intensity variant in restoring back function in nonspecific (chronic) low back pain. In further research, emphasis should be put on identifying subgroups of patients that will have the highest success rate with either of these training approaches.
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Clinical Conference Graded activity for low back pain in occupational health care: a randomized, controlled trial. free! 2004
Staal JB, Hlobil H, Twisk JW, Smid T, Köke AJ, van Mechelen W. · Institute for Research in Extramural Medicine and the Department of Social Medicine, VU University Medical Center, Amsterdam, The Netherlands. · Ann Intern Med. · Pubmed #14734329 links to free full text
Abstract: BACKGROUND: Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce. OBJECTIVE: To determine the effectiveness of a behavior-oriented graded activity program compared with usual care. DESIGN: Randomized, controlled trial. SETTING: Occupational health services department of an airline company in the Netherlands. PATIENTS: 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67). INTERVENTION: Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work. MEASUREMENTS: Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale). RESULTS: The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant. CONCLUSIONS: Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.
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Article Isolated lumbar extensor strengthening versus regular physical therapy in an army working population with nonacute low back pain: a randomized controlled trial. 2008
Helmhout PH, Harts CC, Viechtbauer W, Staal JB, de Bie RA. · Department of Training Medicine and Training Physiology, Personnel Command, Royal Netherlands Army, Utrecht, The Netherlands. · Arch Phys Med Rehabil. · Pubmed #18675396 No free full text.
Abstract: OBJECTIVE: To evaluate the effectiveness of specific lumbar extensor training compared with regular physical therapy (PT) in workers with nonspecific nonacute low back pain (LBP). DESIGN: A multicenter randomized controlled trial with 1-year follow-up. SETTING: PT department in (military primary care) health centers. PARTICIPANTS: Predominantly male soldiers (N=129) with 4 weeks or more of low back complaints who were referred by the health center's general practitioner for PT (mean age, 35.9+/-10.8 y; range, 20-56 y), of whom 127 randomized participants were included in the analyses. One patient withdrew because of adverse effects during treatment. INTERVENTIONS: Participants were assigned to 1 of 2 treatment programs: (1) a 10-week device-supported isolated lumbar extension training, twice a week, or (2) regular PT, mainly consisting of exercise therapy and aerobic activities. MAIN OUTCOME MEASURES: Functional status (Roland-Morris Disability Questionnaire, Patient-Specific Functional Scale) and global perceived effect were assessed in the short term (5 wk, 10 wk) and long term (6 mo, 12 mo). RESULTS: Both groups showed a favorable development in main outcomes over time: short-term improvements (after 10 weeks of treatment) remained stable or even slightly increased throughout the 12-month follow-up. No significant differences between the 2 groups were shown for any of the outcome measures, at any time. CONCLUSIONS: Consistent with prior evidence, specific back strengthening does not seem to offer incremental benefits in LBP management compared with regular PT care that mainly consists of general exercise therapy. (ISRCTN identifier ISRCTN19334317.)
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Article Graded activity for workers with low back pain: who benefits most and how does it work? free! 2008
Staal JB, Hlobil H, Köke AJ, Twisk JW, Smid T, van Mechelen W. · VU University Medical Center, Amsterdam, The Netherlands. · Arthritis Rheum. · Pubmed #18438894 links to free full text
Abstract: OBJECTIVE: To identify subgroups of workers absent from work due to low back pain who are more or less likely to return to work earlier as a result of a graded activity intervention, and to investigate whether this intervention is effective in reducing pain-related fears and if so, whether these reductions in pain-related fears mediate return to work. METHODS: A subgroup analysis was conducted on data from a previous randomized controlled trial of 134 Dutch airline workers, which found that a behaviorally-oriented graded activity intervention was more effective than usual care in stimulating return to work. The subgroup analyses added interaction terms to a Cox regression model that described the relationship between treatment allocation and return to work over 12 months of followup. Furthermore, we studied the effects of graded activity on pain-related fears and added variables indicating a reduction in pain-related fears to the model in order to investigate their influence on return to work. RESULTS: Statistically significant interactions were found for disability, fear-avoidance beliefs about physical activity, and fear-avoidance beliefs about work. No indication was found that the reduction in pain-related fears in the graded activity group mediated more favorable return-to-work results in this group. CONCLUSION: Workers who perceive their disability to be moderate and workers with moderate scores for fear-avoidance beliefs return to work more rapidly as a result of the graded activity intervention than workers with higher scores. The return to work of workers receiving the graded activity intervention is possibly independent from the reductions in pain-related fears caused by this intervention.
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Article A high-intensity lumbar extensor strengthening program is little better than a low-intensity program or a waiting list control group for chronic low back pain: a randomised clinical trial. free! 2008
Harts CC, Helmhout PH, de Bie RA, Staal JB. · Department of Training Medicine and Training Physiology, Utrecht, The Netherlands. · Aust J Physiother. · Pubmed #18298356 links to free full text
Abstract: QUESTION: Is eight weeks of high-intensity strengthening of the isolated lumbar extensors more effective than low-intensity strengthening or no strengthening? Are any gains maintained 16 weeks later? DESIGN: Randomised, three-arm trial with concealed allocation, assessor blinding, and intention-to-treat-analysis. Participants in the waiting list control group were randomised again, after the first 8 weeks, to either the high-intensity or the low-intensity strengthening program. PARTICIPANTS: Sixty-five army personnel with non-specific chronic low back pain. INTERVENTION: The high-intensity training group received 10 sessions of 15 to 20 repetitions for the isolated lumbar extensor muscles. The low-intensity training group received a nonprogressive, low-intensity resistance protocol. OUTCOME MEASURES: Primary outcomes were global perceived effect and disability. Secondary outcomes were health-related quality of life, fear of movement/(re-)injury, and isometric lumbar extensor muscle strength. Measures were taken before and after the training and 16 weeks later. RESULTS: At eight weeks, SF-36 overall score was on average 7% (95% CI 1 to 13) greater in the high-intensity training group compared with the low-intensity training group and the waiting list control group, and self-assessed decrease of back symptoms was on average 39% (95% CI 14 to 64) greater in the high-intensity training group compared with the waiting list control group. There was no difference in improvement between the groups for any other outcome at 8 weeks or 24 weeks. CONCLUSIONS: Although some beneficial effects were found, the results of this high-intensity strengthening program of the isolated lumbar extensor muscles do not clearly support the generally-claimed beneficial influence of exercise for chronic non-specific low back pain.
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Article The effects of a graded activity intervention for low back pain in occupational health on sick leave, functional status and pain: 12-month results of a randomized controlled trial. 2005
Hlobil H, Staal JB, Twisk J, Köke A, Ariëns G, Smid T, van Mechelen W. · Department of Public and Occupational Health, VU University Medical Centre, Amsterdam, The Netherlands. · J Occup Rehabil. · Pubmed #16254756 No free full text.
Abstract: INTRODUCTION: Behaviorally oriented graded activity interventions have been suggested for sick-listed workers with low back pain on return to work, but have not been extensively evaluated. METHODS: One hundred and thirty-four workers were randomly assigned to either a graded activity intervention (n = 67) or usual care (n = 67) and followed-up for 12 months. RESULTS: The graded activity group returned back to work faster with a median of 54 days compared to 67 days in the usual care group. The graded activity intervention was more effective after approximately 50 days post-randomization (HRR = 1.9, CI = 1.2-3.1, p = 0.01). Differences between the groups in number of recurrent episodes, total number of days of sick leave due to low back pain, and total number of days of sick leave due to all diagnoses, were in favor of the graded activity group, although not statistically significant. No effects of the graded activity intervention were found for functional status or pain. CONCLUSION: Graded activity intervention is a valuable strategy to enhance short-term return to work outcomes.
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Article Return-to-work interventions for low back pain: a descriptive review of contents and concepts of working mechanisms. 2002
Staal JB, Hlobil H, van Tulder MW, Köke AJ, Smid T, van Mechelen W. · Department of Social Medicine and Research Centre on Work, Physical Activity and Health, VU University Medical Center, Van der Boechorststraat 7, Amsterdam, The Netherlands. · Sports Med. · Pubmed #11929354 No free full text.
Abstract: Low back pain is a major medical and social problem associated with disability, work absenteeism and high costs. Given the impact of the problem, there is a need for effective treatment interventions in occupational healthcare that aim at the prevention of chronic disability and the realisation of return to work. These so-called return-to-work (RTW) interventions are becoming increasingly popular. As well as questions concerning the effectiveness of RTW interventions, there are also important questions on the actual content and underlying concepts of these multifactorial intervention strategies. The purpose of this review is to examine the literature on the content and underlying concepts of RTW interventions for low back pain. A systematic literature search identified 14 randomised controlled trials (RCTs) evaluating the effects of 19 RTW interventions. The content and concepts of these RTW interventions are described, compared and discussed in this review. Further, the contents of the RTW interventions are classified by the use of predefined components (physical exercises, education, behavioural treatments and ergonomic measures). The identified RTW interventions varied with respect to the disciplines involved, the target population and the number and duration of sessions. The classification showed that physical exercises were a component of most of the selected interventions, followed by education, behavioural treatments and ergonomic measures. The most prevalent combination of components was the combination of physical exercises, behavioural treatment and education. However, the types of physical exercises, behavioural treatment and education varied widely among the RTW interventions. The described concepts for the physical exercises were an increase of muscle strength, coordination, range of motion of the spine and cardiovascular fitness, and a decrease of muscle tension. Education as a part of RTW interventions is believed to increase the understanding of patients regarding their disorder and treatment. Behavioural treatments were mainly based on the gate control theory of pain (psychophysiological processes are involved in pain perception) and/or the operant conditioning hypothesis (pain behaviour is determined by its consequences). No concepts were described for ergonomic measures. Finally, the plausibility of the described concepts is discussed. Future RCTs on this topic should evaluate the underlying concepts of the RTW intervention in addition to its effectiveness.
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Minor Exercise therapy and low back pain: insights and proposals to improve the design, conduct, and reporting of clinical trials. 2008
Helmhout PH, Staal JB, Maher CG, Petersen T, Rainville J, Shaw WS. · Training Medicine and Training Physiology Team, Occupational Health and Safety Service, Royal Netherlands Army, Utrecht, The Netherlands. · Spine (Phila Pa 1976). · Pubmed #18628711 No free full text.
Abstract: STUDY DESIGN: A report on plenary presentations and discussions of an expert panel and workshop ("Exercise as a treatment for subacute low back pain") that was held at the Amsterdam Forum VIII on Low Back Pain Research in Primary Care. OBJECTIVE: To highlight important issues regarding the design, conduct, and reporting of exercise trials and to provide suggestions for improvement in each domain. SUMMARY OF BACKGROUND DATA: Despite improvements in the methodologic quality of randomized clinical trials on low back pain (LBP), current trials on exercise therapy still show methodologic flaws in the design and reporting of studies. METHODS: Important issues in the design, conduct, and reporting of exercise trials for LBP were introduced by 4 presenters, and this was followed by a group discussion among 40 attendees. Conclusions and recommendations were extracted by the workshop panelists and summarized in this paper. RESULTS.: Workshop discussion led to the following recommendations: (1) specify a theoretical framework for exercise therapy for designing the intervention and selecting appropriate treatment efficacy measures; (2) to overcome blinding problems in exercise trials, include sham interventions and assess the success of blinding; (3) evaluate the role of patient-provider interactions through the use of self-report or observational measures; (4) to assure quality of treatment, use exercise interventions that reference existing exercise guidelines; (5) use subgroup analyses to identify subgroups of patients most likely to benefit; (6) in reporting exercise trials, include an extensive description of the study population, a detailed exercise protocol, and some measure of patient compliance; (7) further categorization of exercise interventions is needed, in terms of concept, mode, intensity, duration, frequency, and length; and (8) trial;1>registration and publication of detailed study protocols may help to strengthen the evidence-based concerning exercise therapy for LBP. CONCLUSION: By paying proper attention to issues concerning the design and reporting of exercise protocols when conducting future exercise trials, research may provide a stronger evidence basis for recommending or not recommending various exercise therapies for LBP.
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