A prospective,cluster-randomized controlled trial of exercise program to prevent low back pain in office workers

Purpose

The objective of this study was to evaluate the effects of an exercise program focusing on muscle stretching and endurance training on the 12-month incidence of low back pain (LBP) in office workers.

Methods

A 12-month prospective cluster-randomized controlled trial was conducted in healthy office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance. Healthy office workers (n = 563) were randomly assigned at the cluster level into either intervention (n = 282) or control (n = 281) groups. Participants in the intervention group received an exercise program that included daily stretching exercise and twice-a-week muscle endurance training. Those in the control group received no intervention. The 12-month incidence of LBP was the primary outcome. Secondary outcome were pain intensity, disability level, and quality of life and health status. Analyses were performed using the Cox proportional hazard models.

Results

Over the 12-month follow-up, 8.8 % of participants in the intervention group and 19.7 % in the control group developed incidence of LBP. Hazard rate ratios showed a protective effect of the exercise program for LBP (HR = 0.37, 95 % CI 0.22–0.64) after adjusting for biopsychosocial factors. There was no significant difference in pain intensity, disability, and quality of life and health status between those who reported incidence of LBP in the intervention and control groups.

Conclusion

An exercise program consisting of muscle stretching and endurance training is an effective intervention to reduce incident LBP for office workers with lower-than-normal trunk extension flexibility or trunk muscle endurance.     

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.     

Risk factors for sickness absence due to low back pain and prognostic factors for return to work in a cohort of shipyard workers

The purpose of this study was to determine risk factors for the occurrence of sickness absence due to low back pain (LBP) and to evaluate prognostic factors for return to work. A longitudinal study with 1-year follow-up was conducted among 853 shipyard workers. The cohort was drawn around January 2004 among employees in the shipyard industry. Baseline information was obtained by questionnaire on physical and psychosocial work load, need for recovery, perceived general health, musculoskeletal complaints, sickness absence, and health care use during the past year. During the 1-year follow-up for each subject medical certifications were retrieved for information on the frequency and duration of spells of sickness absence and associated diagnoses. Cox regression analyses were conducted on occurrence and on duration of sickness absence with hazard ratios (HR) with 95% confidence interval (95% CI) as measure of association. During the 1-year follow-up period, 14% of the population was on sick leave at least once with LBP while recurrence reached 41%. The main risk factors for sickness absence were previous absence due to a health problem other than LBP (HR 3.07; 95%CI 1.66–5.68) or previous sickness absence due to LBP (HR 6.52; 95%CI 3.16–13.46). Care seeking for LBP and lower educational level also hold significant influences (HR 2.41; 95%CI 1.45–4.01 and HR 2.46; 95%CI 1.19–5.07, respectively). Living with others, night shift and supervising duties were associated with less absenteeism due to LBP. Workers with a history of herniated disc had a significantly decreased rate of returning to work, whereas those who suffered from hand-wrist complaints and LBP returned to work faster. Prior sick leave due to LBP partly captured the effects of work-related physical and psychosocial factors on occurrence of sick leave. Our study showed that individual and job characteristics (living alone, night shift, lower education, sick leave, or care seeking during the last 12 months) influenced the decision to take sick leave due to LBP. An increased awareness of those frequently on sick leave and additional management after return to work may have a beneficial effect on the sickness absence pattern.     

Active rehabilitation for chronic low back pain: Cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229]

Background  

The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations: the deconditioning model, the cognitive behavioral model and the biopsychosocial model.     

Stay@Work: Participatory Ergonomics to prevent low back and neck pain among workers: design of a randomised controlled trial to evaluate the (cost-)effectiveness

Background  

Low back pain (LBP) and neck pain (NP) are a major public health problem with considerable costs for individuals, companies and society. Therefore, prevention is imperative. The Stay@Work study investigates the (cost-)effectiveness of Participatory Ergonomics (PE) to prevent LBP and NP among workers.     

Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617]

Background  

Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain.     

The McKenzie method for the management of acute non-specific low back pain: design of a randomised controlled trial [ACTRN012605000032651]

Background  

Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.     

Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649]

Background

Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably.

Methods

In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation.

Discussion

No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

     

PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

Background  

Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP.     

Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial [ISRCTN20244858]

Background  

Studies on exercise in knee osteoarthritis (OA) have focused on elderly subjects. Subjects in this study were middle-aged with symptomatic and definite radiographic knee osteoarthritis. The aim was to test the effects of a short-term, high-intensity exercise program on self-reported pain, function and quality of life.     

Primary care consultation, hospital admission, sick leave and disability pension owing to neck and low back pain: a 12-year prospective cohort study in a rural population

Background  

Neck and low back pain are common musculoskeletal complaints generating large societal costs in Western populations. In this study we evaluate the magnitude of long-term health outcomes for neck and low back pain, taking possible confounders into account.     

A controlled, prospective study to evaluate the effectiveness of a back school in the relief of chronic low back pain

Ninety-two chronic low back pain patients were randomly allocated to two groups to evaluate the effectiveness of a back school compared with an exercise-only regimen according to specified outcome variables. The data from 78 patients with 7 years mean duration of symptoms was analyzed. Three assessments were made: before treatment and 6 and 16 weeks after treatment. Changes in patients' levels of pain, functional disability, and other related variables were compared in the two groups. Almost all variables showed an improvement at 6 weeks. At 16 weeks, functional disability and pain levels showed a significant difference. Back school patients continued to make an improvement. This method of managing low back pain makes maximal use of limited resources and appears to be effective, especially in the longer term.     

Postsurgical pain outcome of vertical and transverse abdominal incision: Design of a randomized controlled equivalence trial [ISRCTN60734227]

Background

There are two ways to open the abdominal cavity in elective general surgery: vertically or transversely. Various clinical studies and a meta-analysis have postulated that the transverse approach is superior to other approaches as regards complications. However, in a recent survey it was shown that 90 % of all abdominal incisions in visceral surgery are still vertical incisions. This discrepancy between existing recommendations of clinical trials and clinical practice could be explained by the lack of acceptance of these results due to a number of deficits in the study design and analysis, subsequent low internal validity, and therefore limited external generalisability. The objective of this study is to address the issue from the patient's perspective.

Methods

This is an intraoperatively randomized controlled observer and patient-blinded two-group parallel equivalence trial. The study setting is the Department of General-, Visceral-, Trauma Surgery and Outpatient Clinic of the University of Heidelberg, Medical School. A total of 172 patients of both genders, aged over 18 years who are scheduled for an elective abdominal operation and are eligible for either a transverse or vertical incision. To show equivalence of the two approaches or the superiority of one of them from the perspective of the patient, a primary endpoint is defined: the pain experienced by the patient (VAS 0–100) on day two after surgery and the amount of analgesic required (piritramide [mg/h]). A confidence interval approach will be used for analysis. A global α-Level of 0.05 and a power of 0.8 is guaranteed, resulting in a size of 86 patients for each group. Secondary endpoints are: time interval to open and close the abdomen, early-onset complications (frequency of burst abdomen, postoperative pulmonary complications, and wound infection) and late complications (frequency of incisional hernias). Different outcome variables will be ranked by patients and surgeons to assess the relevance of possible endpoints from the patients' and surgeons' perspective.

Conclusion

This is a randomized controlled observer and patient-blinded two-group parallel trial to answer the question if the transverse abdominal incision is equivalent to the vertical one due to the described endpoints.

     

Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (−45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (−73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.