Project description:IntroductionChronic low back pain (LBP) is a major health problem worldwide. Multidisciplinary rehabilitation and exercise is recommended for the management of chronic LBP. However, there is a need to investigate effective exercise interventions that is available in clinics and as home-based training on a large scale. This article presents the design and rationale of the first randomized clinical trial investigating the effects of progressive resistance training with elastic bands in addition to multidisciplinary rehabilitation for patients with moderate to severe chronic LBP.Methods and analysisWe aim to enroll 100 patients with chronic LBP referred to a specialized outpatient hospital clinic in Norway. Participants will be randomized equally to either; a) 3 tion including whole-body progressive resistance training using elastic bands - followed by home-based progressive resistance training for 9 weeks, or b) 3 weeks of multidisciplinary rehabilitation including general physical exercise - followed by home-based general physical exercise for 9 weeks. Questionnaires and strength tests will be collected at baseline, weeks 3 and 12, and at 6 and 12 months. The primary outcome is between-group changes in pain-related disability at week 12 assessed by the Oswestry disability index. Secondary outcomes include pain, work ability, work status, mental health, health-related quality of life, global rating of change, general health, and muscular strength and pain-related disability up to 12 months of follow-up.DiscussionThis study will provide valuable information for clinicians working with patients with chronic LBP.Trial registrationClinicalTrials.gov, number NCT02420236.
Project description:BackgroundMillions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.MethodsThe aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).DiscussionAn improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.Trial registrationDRKS, DRKS00020373 . Registered on 15 April 2020.
Project description:ObjectiveTo assess the effect of multidisciplinary biopsychosocial rehabilitation on clinically relevant outcomes in patients with chronic low back pain.DesignSystematic literature review of randomised controlled trials.ParticipantsA total of 1964 patients with disabling low back pain for more than three months.Main outcome measuresPain, function, employment, quality of life, and global assessments.ResultsTen trials reported on a total of 12 randomised comparisons of multidisciplinary treatment and a control condition. There was strong evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration improves function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary biopsychosocial intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psychophysical treatments did not improve pain, function, or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments.ConclusionsThe reviewed trials provide evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain and improves function in patients with chronic low back pain. Less intensive interventions did not show improvements in clinically relevant outcomes.
Project description:BackgroundLow back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted.ObjectiveWe aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization.MethodsThis is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023.ResultsThe researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023.ConclusionsOur trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services.Trial registrationBrazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/.International registered report identifier (irrid)PRR1-10.2196/31345.
Project description:BackgroundLow back pain (LBP) has a lifetime prevalence of 70-80%. Access to timely and personalized, evidence-based care is key to prevent chronic progression. Digital solutions may ease accessibility to treatment while reducing healthcare-related costs.PurposeWe aim to report the results of a fully remote digital care program (DCP) for acute LBP.Patients and methodsThis was an interventional, single-arm, cohort study of patients with acute LBP who received a DCP. Primary outcome was the mean change in disability (Oswestry Disability Index - ODI) after 12 weeks. Secondary outcomes included change in pain (NPRS), analgesic consumption, surgery likelihood, depression (PHQ-9), anxiety (GAD-7), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI) and engagement.ResultsA total of 406 patients were enrolled in the program and of those, 332 (81.8%) completed the intervention. A significant disability reduction of 55.1% (14.93, 95% CI 13.95; 15.91) was observed, corresponding to a 76.1% responder rate (30% cut-off). Disability reduction was accompanied by significant improvements in pain (61.0%), depression (55.4%), anxiety (59.5%), productivity (65.6%), fear-avoidance beliefs (46.3%), intent to pursue surgery (59.1%), and analgesic consumption (from 35.7% at baseline to 10.8% at program end). DCP-related patient satisfaction score was 8.7/10.0 (SD 1.4).ConclusionThis study demonstrated the utility of a multimodal DCP for patients with acute LBP. Very high adherence rates and patient satisfaction were observed, alongside significant reductions in all assessed outcomes, consistent with the growing body of evidence supporting the management of acute LBP with DCPs.
Project description:BackgroundChronic low back pain (CLBP) is an important disorder in athletes that may negatively affect their performance in competitions. The literature usually recommends physiotherapy based on exercises for back pain management in athletes. Recent evidence suggests that interventions based on lumbar muscle stabilisation exercises (LMSE) and back endurance-resistance exercises (BERE) may improve back pain and function performance. However, it is still unclear which type of exercise is more effective for the treatment of CLBP in athletes.ObjectiveTo compare the efficacy of LMSE versus BERE in athletes with CLBP.DesignThe study is a 2-arm, prospectively registered, randomised controlled trial.SettingThe physical therapy clinical and biomechanics laboratory of the UNOPAR University.Participants32 male athletes with CLBP, age between 18 and 40 years old, recruited from the local community.InterventionAn 8-week intervention programme will be carried out with LMSE s versus BERE.MeasurementsTrunk neuromuscular patterns during balance tasks (unipodal and over a ball) using electromyography and force platform parameters, pain, disability, fear and avoidance will be assessed by a blinded assessor at baseline and at follow-up after 8 weeks of intervention period.LimitationsThe absence of blinding intervention and the exclusion of female athletes, seated sports and swimmers will affect the internal and external validity of the study.ConclusionsThe results of this study will elucidate which of these two interventions promote better results in trunk neuromuscular pattern, back pain and function in male athletes with CLBP.
Project description:Home-based exercises have been on the rise recently. This pilot study aimed to assess the adherence and effect of a home-based rehabilitation programme using telemonitoring in patients with chronic non-specific low back pain (CNLBP). Twenty-seven patients with CNLBP were enrolled in the study, each of whom underwent a neurological assessment, including patient-oriented measures and a functional assessment-a battery of tests that comprehensively evaluated trunk muscle function. The rehabilitation programme lasted 18 weeks and included daily home-based exercises. A mobile application or an exercise diary was used to monitor compliance. Adherence to the programme was excellent for both the diary and mobile application groups, with 82.3% in the diary group exercising at least once a day and 72.9% twice a day, and 94.8% in the mobile application group exercising at least once a day and 86.6% twice a day. Both patient-oriented and functional outcomes improved significantly; however, the relative changes of the parameters in these two groups did not correlate, which supports the idea that trunk muscle function does not directly relate to patient complaints and that CNLBP is a multifactorial issue. This model of rehabilitation programme should be used in clinical practice, as its adherence and effectiveness seem noticeable.
Project description:Purpose: Low back pain is a chronic condition that limits function. The chief reason individuals with low back pain seek care is difficulty performing functional activities. A novel approach to improving performance of painful and limited functional activities is motor skill training, defined as challenging practice of activities to learn or relearn a skill. The purpose of this report is to describe the design and application of a motor skill training intervention in a 26-year-old man with a 10-year history of low back pain. Methods: A motor skill training intervention was implemented to modify the altered alignment and movement patterns he used during the performance of his painful and limited activities. Results: The patient was seen for six visits in 12 weeks. The patient reported decreased pain and medication use, as well as improved function immediately, 3-, and 9-months post-intervention. Conclusion: Individuals with low back pain report limitation in ability to perform everyday functions and demonstrate altered patterns of movement and alignment during these activities. This case report describes an innovative motor skill training intervention that directly addresses the performance of functional activities and the application of motor learning principles. Implications for rehabilitation Low back pain is a chronic condition that limits function. The chief reason individuals with chronic low back pain seek care is difficulty performing everyday functional activities. Motor skill training is a novel approach that directly addresses the performance of painful and limited functional activities through challenging practice to improve performance and decrease pain.
Project description:BACKGROUND:Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment. METHODS/DESIGN:For this prospective randomized controlled study, participants will be randomly assigned to three groups: (1) APA group (active points related to cLBP), (2) Comparison group-1 (non-active points, unrelated to cLBP), and (3) Comparison group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly telephone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post APA treatment, and follow-up study visits at 1, 3, 6, 9 and 12 months post completion of treatment for a total of seven assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels. DISCUSSION:This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03589703. Registered on 22 May 2018.
Project description:BackgroundSensorimotor training (SMT) is popularly applied as a preventive or rehabilitative exercise method in various sports and rehabilitation settings. Yet, there is only low-quality evidence on its effect on pain and function. This randomised controlled trial will investigate the effects of a theory-based SMT in rehabilitation of chronic (>3 months) non-specific low back pain (CNLBP) patients.Methods/designA pilot study with a parallel, single-blinded, randomised controlled design. Twenty adult patients referred to the clinic for CNLBP treatment will be included, randomised, and allocated to one of two groups. Each group will receive 9 x 30 minutes of standard physiotherapy (PT) treatment. The experimental group will receive an added 15 minutes of SMT. For SMT, proprioceptive postural exercises are performed on a labile platform with adjustable oscillation to provoke training effects on different entry levels. The active comparator group will perform 15 minutes of added sub-effective low-intensity endurance training. Outcomes are assessed on 4 time-points by a treatment blinded tester: eligibility assessment at baseline (BL) 2-4 days prior to intervention, pre-intervention assessment (T0), post-intervention assessment (T1), and at 4 weeks follow-up (FU). At BL, an additional healthy control group (n = 20) will be assessed to allow cross-sectional comparison with symptom-free participants. The main outcomes are self-reported pain (Visual Analogue Scale) and functional status (Oswestry Disability Index). For secondary analysis, postural control variables after an externally perturbed stance on a labile platform are analysed using a video-based marker tracking system and a pressure plate (sagittal joint-angle variability and centre of pressure confidence ellipse). Proprioception is measured as relative cervical joint repositioning error during a head-rotation task. Effect sizes and mixed-model MANOVA (2 groups × 4 measurements for 5 dependent variables) will be calculated.DiscussionThis is the first attempt to systematically investigate effects of a theory-based sensorimotor training in patients with CNLBP. It will provide analysis of several postural segments during a dynamic task for quantitative analysis of quality and change of the task performance in relation to changes in pain and functional status.Trial registrationTrial registry number on cliniclatrials.gov is NCT02304120 , first registered on 17 November 2014.