PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-11 (11)
 

Clipboard (0)
None
Journals
Year of Publication
Document Types
1.  Prospective research on musculoskeletal disorders in office workers (PROMO): study protocol 
Background
This article describes the background and study design of the PROMO study (Prospective Research on Musculoskeletal disorders in Office workers). Few longitudinal studies have been performed to investigate the risk factors responsible for the incidence of hand, arm, shoulder and neck symptoms among office workers, given the observation that a large group of office workers might be at risk worldwide. Therefore, the PROMO study was designed. The main aim is to quantify the contribution of exposure to occupational computer use to the incidence of hand, arm, shoulder and neck symptoms. The results of this study might lead to more effective and/or cost-efficient preventive interventions among office workers.
Methods/Design
A prospective cohort study is conducted, with a follow-up of 24 months. In total, 1821 participants filled out the first questionnaire (response rate of 74%). Data on exposure and outcome is collected using web-based self-reports. Outcome assessment takes place every three months during the follow-up period. Data on computer use are collected at baseline and continuously during follow-up using a software program.
Discussion
The advantages of the PROMO study include the long follow-up period, the repeated measurement of both exposure and outcome, and the objective measurement of the duration of computer use. In the PROMO study, hypotheses stemming from lab-based and field-based research will be investigated.
doi:10.1186/1471-2474-7-55
PMCID: PMC1550718  PMID: 16822300
2.  Cost-effectiveness of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: design of a randomised controlled trial 
Background
Within the working population there is a vulnerable group: workers without an employment contract and workers with a flexible labour market arrangement, e.g. temporary agency workers. In most cases, when sick-listed, these workers have no workplace/employer to return to. Also, for these workers access to occupational health care is limited or even absent in many countries. For this vulnerable working population there is a need for tailor-made occupational health care, including the presence of an actual return-to-work perspective. Therefore, a participatory return-to-work program has been developed based on a successful return-to-work intervention for workers, sick-listed due to low back pain.
The objective of this paper is to describe the design of a randomised controlled trial to study the (cost-)effectiveness of this newly developed participatory return-to-work program adapted for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders, compared to usual care.
Methods/Design
The design of this study is a randomised controlled trial with one year of follow-up. The study population consists of temporary agency workers and unemployed workers sick-listed between 2 and 8 weeks due to musculoskeletal disorders. The new return-to-work program is a stepwise program aimed at making a consensus-based return-to-work implementation plan with the possibility of a (therapeutic) workplace to return-to-work. Outcomes are measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure is duration of the sickness benefit period after the first day of reporting sick. Secondary outcome measures are: time until first return-to-work, total number of days of sickness benefit during follow-up; functional status; intensity of musculoskeletal pain; pain coping; and attitude, social influence and self-efficacy determinants. Cost-benefit is evaluated from an insurer's perspective. A process evaluation is part of this study.
Discussion
For sick-listed workers without an employment contract there can be gained a lot by improving occupational health care, including return-to-work guidance, and by minimising the 'labour market handicap' by creating a return-to-work perspective. In addition, reduction of sickness absence and work disability, i.e. a reduction of disability claims, may result in substantial benefits for the Dutch Social Security System.
Trial registration
Trial registration number: NTR1047.
doi:10.1186/1471-2474-11-60
PMCID: PMC2858719  PMID: 20346183
3.  The implementation effectiveness of the ‘Strengthen your ankle’ smartphone application for the prevention of ankle sprains: design of a randomized controlled trial 
Background
Ankle sprains continue to pose a significant burden to the individual athlete, as well as to society as a whole. However, despite ankle sprains being the single most common sports injury and despite an active approach by various Dutch organisations in implementing preventive measures, large-scale community uptake of these preventive measures, and thus actual prevention of ankle sprains, is lagging well behind. In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute VeiligheidNL developed a freely available interactive App (‘Strenghten your ankle’ translated in Dutch as: ‘Versterk je enkel; available for iOS and Android) that contains - next to general advice on bracing and taping - a proven cost-effective neuromuscular program. The ‘Strengthen your ankle’ App has not been evaluated against the ‘regular’ prevention approach in which the neuromuscular program is advocated through written material. The aim of the current project is to evaluate the implementation value of the ‘Strengthen your ankle’ App as compared to the usual practice of providing injured athletes with written materials. In addition, as a secondary outcome measure, the cost-effectiveness will be assessed against usual practice.
Methods/Design
The proposed study will be a randomised controlled trial. After stratification for medical caregiver, athletes will be randomised to two study groups. One group will receive a standardized eight-week proprioceptive training program that has proven to be cost-effective to prevent recurrent ankle injuries, consisting of a balance board (machU/ MSG Europe BVBA), and a traditional instructional booklet. The other group will receive the same exercise program and balance board. However, for this group the instructional booklet is exchanged by the interactive ‘Strengthen your ankle’ App.
Discussion
This trial is the first randomized controlled trial to study the implementation effectiveness of an App for proprioceptive balance board training program in comparison to a traditional printed instruction booklet, with the recurrence of ankle sprains among athletes as study outcome. Results of this study could possibly lead to changes in practical guidelines on the treatment of ankle sprains and in the use of mobile applications for injury prevention. Results will become available in 2014.
Trial registration
The Netherlands National Trial Register NTR4027. The NTR is part of the WHO Primary Registries.
doi:10.1186/1471-2474-15-2
PMCID: PMC3923004  PMID: 24393146
Mobile health; Ankle sprains; Ankle injury; Prevention; Neuromuscular training
4.  Ankles back in randomized controlled trial (ABrCt): braces versus neuromuscular exercises for the secondary prevention of ankle sprains. Design of a randomised controlled trial 
Background
Ankle sprains are the most common sports and physical activity related injury. There is extensive evidence that there is a twofold increased risk for injury recurrence for at least one year post injury. In up to 50% of all cases recurrences result in disability and lead to chronic pain or instability, requiring prolonged medical care. Therefore ankle sprain recurrence prevention in athletes is essential. This RCT evaluates the effect of the combined use of braces and neuromuscular training (e.g. proprioceptive training/sensorimotor training/balance training) against the individual use of either braces or neuromuscular training alone on ankle sprain recurrences, when applied to individual athletes after usual care.
Methods/Design
This study was designed as three way randomized controlled trial with one year follow-up. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain in the two months prior to inclusion, were eligible for inclusion. After subjects had finished ankle sprain treatment by means of usual care, they were randomised to any of the three study groups. Subjects in group 1 received an eight week neuromuscular training program, subjects in group 2 received a sports brace to be worn during all sports activities for the duration of one year, and group 3 received a combination of the neuromuscular training program and a sports brace to be worn during all sports activities for the duration of eight weeks. Outcomes were assessed at baseline and every month for 12 months therafter. The primary outcome measure was incidence of ankle sprain recurrences. Secondary outcome measures included the direct and indirect costs of recurrent injury, the severity of recurrent injury, and the residual complaints during and after the intervention.
Discussion
The ABrCt is the first randomized controlled trial to directly compare the secondary preventive effect of the combined use of braces and neuromuscular training, against the use of either braces or neuromuscular training as separate secondary preventive measures. This study expects to identify the most effective and cost-efficient secondary preventive measure for ankle sprains. The study results could lead to changes in the clinical guidelines on the prevention of ankle sprains, and they will become available in 2012.
Trial registration
Netherlands Trial Register (NTR): NTR2157
doi:10.1186/1471-2474-12-210
PMCID: PMC3195211  PMID: 21951559
5.  Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial 
Background
Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population.
Methods/Design
This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data).
Discussion
This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain.
Trial Registration
Current controlled trial ISRCTN54009836
doi:10.1186/1471-2474-11-70
PMCID: PMC2873461  PMID: 20398349
6.  An integrated care program to prevent work disability due to chronic low back pain: a process evaluation within a randomized controlled trial 
Background
In the past decade, a considerable amount of research has been carried out to evaluate the effectiveness of innovative low back pain (LBP) interventions. Although some interventions proved to be effective, they are not always applied in daily practice. To successfully implement an innovative program it is important to identify barriers and facilitators in order to change practice routine. Because usual care is not directly aimed at return to work (RTW), we evaluated an integrated care program, combining a patient-directed and a workplace-directed intervention provided by a multidisciplinary team, including a clinical occupational physician to reduce occupational disability in chronic LBP patients. The aims of this study were to describe the feasibility of the implementation of the integrated care program, to assess the satisfaction and expectations of the involved stakeholders and to describe the needs for improvement of the program.
Methods
Eligible for this study were patients who had been on sick leave due to chronic LBP. Data were collected from the patients, their supervisors and the involved health care professionals, by means of questionnaires and structured charts, during 3-month follow-up. Implementation, satisfaction and expectations were investigated.
Results
Of the 40 patients who were eligible to participate in the integrated care program, 37 patients, their supervisors and the health care professionals actually participated in the intervention. Adherence to the integrated care program was in accordance with the protocol, and the patients, their supervisors and the health care professionals were (very) satisfied with the program. The role of the clinical occupational physician was of additional value in the RTW process. Time-investment was the only barrier for implementation reported by the multidisciplinary team.
Conclusion
The implementation of this program will not be influenced by any flaws in its application that are related to the program itself, or to the adherence of patients with chronic LBP and their health care professionals.
This program is promising in terms of feasibility, satisfaction and compliance of the patients, their supervisors and the health care professionals. Before implementation on a wider scale, the communication and the information technology of the program should be improved.
Trials Registration
[ISRCTN28478651]
doi:10.1186/1471-2474-10-147
PMCID: PMC2791096  PMID: 19943976
7.  A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial) 
Background
Chronic low back pain (CLBP) is a persistent disabling condition with rising significant healthcare, social and economic costs. Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery. While international clinical guidelines and systematic reviews for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost, barriers to their delivery include space and time restrictions in healthcare settings and poor patient attendance. The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP. Walking may be an ideally suited form of individualized exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all ages with little risk of injury, but its effectiveness for LBP is unproven.
Methods and design
This study will be an assessor-blinded randomized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy, which will act as the control group, in people with chronic low back pain. A sample of 246 patients will be recruited in Dublin, Ireland through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP. Patients will be randomly allocated to one of the three groups in a concealed manner. The main outcomes will be functional disability, pain, quality of life, fear avoidance, back beliefs, physical activity, satisfaction and costs, which will be evaluated at baseline, and 3, 6 and 12 months [follow-up by pre-paid postage]. Qualitative telephone interviews and focus groups will be embedded in the research design to obtain feedback about participants' experiences of the interventions and trial participation, and to inform interpretation of the quantitative data. Planned analysis will be by intention to treat (quantitative data) and thematic analysis (qualitative data)
Discussion
The trial will evaluate the effectiveness of a walking programme and a supervised general exercise programme compared to usual physiotherapy in people with CLBP.
Trial registration
Current controlled trial ISRCTN17592092
doi:10.1186/1471-2474-10-79
PMCID: PMC2714003  PMID: 19573247
8.  The 2BFit study: is an unsupervised proprioceptive balance board training programme, given in addition to usual care, effective in preventing ankle sprain recurrences? Design of a Randomized Controlled Trial 
Background
There is strong evidence that athletes have a twofold risk for re-injury after a previous ankle sprain, especially during the first year post-injury. These ankle sprain recurrences could result in disability and lead to chronic pain or instability in 20 to 50% of these cases. When looking at the high rate of ankle sprain recurrences and the associated chronic results, ankle sprain recurrence prevention is important.
Objective
To evaluate the effect of a proprioceptive balance board training programme on ankle sprain recurrences, that was applied to individual athletes after rehabilitation and treatment by usual care.
Methods/Design
This study was designed as a randomized controlled trial with a follow-up of one year. Healthy individuals between 12 and 70 years of age, who were actively participating in sports and who had sustained a lateral ankle sprain up to two months prior to inclusion, were eligible for inclusion in the study. The intervention programme was compared to usual care. The intervention programme consisted of an eight-week proprioceptive training, which started after finishing usual care and from the moment that sports participation was again possible. Outcomes were assessed at baseline and every month for 12 months. The primary outcome of this study was the incidence of recurrent ankle injuries in both groups within one year after the initial sprain. Secondary outcomes were severity and etiology of re-injury and medical care. Cost-effectiveness was evaluated from a societal perspective. A process evaluation was conducted for the intervention programme.
Discussion
The 2BFit trial is the first randomized controlled trial to study the effect of a non-supervised home-based proprioceptive balance board training programme in addition to usual care, on the recurrence of ankle sprains in sports. Results of this study could possibly lead to changes in practical guidelines on the treatment of ankle sprains. Results will become available in 2009.
Trial registration
ISTRCN34177180.
doi:10.1186/1471-2474-9-71
PMCID: PMC2412867  PMID: 18492235
9.  The GRONORUN study: is a graded training program for novice runners effective in preventing running related injuries? Design of a Randomized Controlled Trial 
Background
Running is a popular form of recreational exercise. Beside the positive effects of running on health and fitness, the risk of a running related injury has to be considered. The incidence of injuries in runners is high and varies from 30–79%. However, few intervention studies on prevention of running related injuries have been performed and none of these studies involved novice runners.
Methods
GRONORUN (Groningen Novice Running) is a two armed randomized controlled trial, comparing the effects of two different training programs for novice runners on the incidence of running related injuries. Participants are novice runners, who want to train for a four mile running event. The control group will train according a standard 8 week training program. The intervention group will use a more gradual, 13 week training program which is based on "the ten percent training rule". During the thirteen week follow up participants register information on running and RRI's in an internet based running log. The primary outcome measure is RRI. An injury is defined as a musculoskeletal ailment of the lower extremity or back, causing a restriction of running for at least one week.
Discussion
The GRONORUN trial is the first randomized controlled trial to study a preventive intervention in novice runners. Many different training programs for novice runners are offered, but none are evidence based.
doi:10.1186/1471-2474-8-24
PMCID: PMC1821023  PMID: 17331264
10.  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.
doi:10.1186/1471-2474-5-45
PMCID: PMC535932  PMID: 15560843
11.  Cost effectiveness of a multi-stage return to work program for workers on sick leave due to low back pain, design of a population based controlled trial [ISRCTN60233560] 
Background
To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2–8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back pain management.
Methods
Design
An RCT and cost-effectiveness evaluation in employees sick-listed for a period of 2 to 6 weeks due to low back pain. Interventions used are 1. Communication between general practitioner and occupational physician plus Participative Ergonomics protocol performed by an ergonomist. 2. Graded Activity based on cognitive behavioural principles by a physiotherapist. 3. Usual care, provided by an occupational physician according to the Dutch guidelines for the occupational health management of workers with low back pain. The primary outcome measure is return to work. Secondary outcome measures are pain intensity, functional status and general improvement. Intermediate variables are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs due to low back pain. The outcome measures are assessed before randomization (after 2–6 weeks on sick leave) and 12 weeks, 26 weeks and 52 weeks after first day of sick leave.
Discussion
The combination of these interventions has been subject of earlier research in Canada. The results of the current RCT will: 1. crossvalidate the Canadian findings in an different sociocultural environment; 2. add to the cost-effectiveness on treatment options for workers in the sub acute phase of low back pain. Results might lead to alterations of existing (inter)national guidelines.
doi:10.1186/1471-2474-4-26
PMCID: PMC317323  PMID: 14629775
Low back pain; Graded Activity; Participative Ergonomics; Return to work; Randomized Controlled Trial; Cost-effectiveness; Occupational health

Results 1-11 (11)