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.     

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.     

The cost-effectiveness of a treatment-based classification system for low back pain: design of a randomised controlled trial and economic evaluation

Background

Systematic reviews have shown that exercise therapy and spinal manipulation are both more effective for low back pain (LBP) than no treatment at all. However, the effects are at best modest. To enhance the clinical outcomes, recommendations are to improve the patient selection process, and to identify relevant subgroups to guide clinical decision-making. One of the systems that has potentials to improve clinical decision-making is a treatment-based classification system that is intended to identify those patients who are most likely to respond to direction-specific exercises, manipulation, or stabilisation exercises.

Methods/Design

The primary aim of this randomised controlled trial will be to assess the effectiveness of a classification-based system. A sample of 150 patients with subacute and chronic LBP who attend a private physical therapy clinic for treatment will be recruited. At baseline, all participants will undergo a standard evaluation by trained research physical therapists and will be classified into one of the following subgroups: direction-specific exercises, manipulation, or stabilisation. The patient will not be informed about the results of the examination. Patients will be randomly assigned to classification-based treatment or usual care according to the Dutch LBP guidelines, and will complete questionnaires at baseline, and 8, 26, and 52 weeks after the start of the treatment. The primary outcomes will be general perceived recovery, functional status, and pain intensity. Alongside this trial, an economic evaluation of cost-effectiveness and cost-utility will be conducted from a societal perspective.

Discussion

The present study will contribute to our knowledge about the effectiveness and cost-effectiveness of classification-based treatment in patients with LBP.

Trial registration

Trial registration number: NTR1176     

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.     

Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

Background

The aims of this study were to evaluate the construct validity (known group), concurrent validity (criterion based) and test-retest (intra-rater) reliability of manual goniometers to measure passive hip range of motion (ROM) in femoroacetabular impingement patients and healthy controls.

Methods

Passive hip flexion, abduction, adduction, internal and external rotation ROMs were simultaneously measured with a conventional goniometer and an electromagnetic tracking system (ETS) on two different testing sessions. A total of 15 patients and 15 sex- and age-matched healthy controls participated in the study.

Results

The goniometer provided greater hip ROM values compared to the ETS (range 2.0-18.9 degrees; P < 0.001); good concurrent validity was only achieved for hip abduction and internal rotation, with intraclass correlation coefficients (ICC) of 0.94 and 0.88, respectively. Both devices detected lower hip abduction ROM in patients compared to controls (P < 0.01). Test-retest reliability was good with ICCs higher 0.90, except for hip adduction (0.82-0.84). Reliability estimates did not differ between the goniometer and the ETS.

Conclusions

The present study suggests that goniometer-based assessments considerably overestimate hip joint ROM by measuring intersegmental angles (e.g., thigh flexion on trunk for hip flexion) rather than true hip ROM. It is likely that uncontrolled pelvic rotation and tilt due to difficulties in placing the goniometer properly and in performing the anatomically correct ROM contribute to the overrating of the arc of these motions. Nevertheless, conventional manual goniometers can be used with confidence for longitudinal assessments in the clinic.     

Exercise for the intervertebral disc: a 6-month randomised controlled trial in chronic low back pain

European Spine Journal - Muscle, bone and tendon respond anabolically to mechanical forces. Whether the intervertebral disc (IVD) can benefit from exercise is unclear. To examine whether exercise...     

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.     

Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial

Background  

Manipulation is a common treatment for non-specific neck pain. Neck manipulation, unlike gentler forms of manual therapy such as mobilisation, is associated with a small risk of serious neurovascular injury and can result in stroke or death. It is thought however, that neck manipulation provides better results than mobilisation where clinically indicated. There is long standing and vigorous debate both within and between the professions that use neck manipulation as well as the wider scientific community as to whether neck manipulation potentially does more harm than good. The primary aim of this study is to determine whether neck manipulation provides more rapid resolution of an episode of neck pain than mobilisation.     

Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

Background  

Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain.     

Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial

Background  

Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.     

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.

     

Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.     

Prefabricated foot orthoses compared to a placebo intervention for the treatment of chronic nonspecific low back pain: a study protocol for a randomised controlled trial

Background

Prefabricated foot orthoses are used to treat chronic nonspecific low back pain, however their effectiveness and potential mechanism of action is unclear. The primary aims of the study are to investigate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks.

Methods

This study is a participant and assessor blinded, parallel-group, superiority randomised (1:1) controlled trial. The study will recruit 60 participants aged 18 to 65 years with chronic nonspecific low back pain. Participants will undergo randomisation to a control group (The Back Book) or an intervention group (prefabricated foot orthoses and The Back Book). The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52 weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12 weeks, physical activity over 12, 26, and 52 weeks, and correlation between foot type and change in measures of pain and function. Number of hours per day and week that the prefabricated orthoses are worn, as well as, adverse events will be self-reported by participants. Data will be analysed using the intention-to-treat principle.

Discussion

This trial will primarily evaluate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks. It is expected that this study will provide clinicians and researchers with an understanding of the role that prefabricated foot orthoses may have in the treatment of chronic nonspecific low back pain and a potential mechanism of action, and whether foot type influences the outcome.

Trial registration

ACTRN12618001298202.

     

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.     

Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

Background

Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial.

Methods/design

This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively.

Discussion

This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition.

Trial registration

Brazilian Registry of Clinical Trials RBR-7tyg5j