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Integral movement therapy versus local movement therapy approach in patients with idiopathic chronic low-back pain: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Chronic low-back pain (CLBP) is one of the most common reasons for seeking medical care and it imposes a significant burden on individuals and society at large. Systematic reviews evaluating the effectiveness of supervised exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another. Randomized controlled trials (RCT) to date included mostly trunk strengthening exercises (e.g. bird dog, plank) and there is no evidence about supervised, individually graded integral movement therapy program for patients with CLBP. METHODS:The research design is a RCT with parallel-group design including two intervention groups: integral movement therapy and conventional local movement therapy. Participants in each group will receive 20 supervised sessions in a 10-week period, twice per week, for approximately 1?h per session. Outcome assessments will occur at baseline and immediately after intervention, follow-up will take place at six?months and 12?months after the intervention. Prespecified analyses will evaluate the main effects of the treatment. DISCUSSION:This trial will use a novel, previously unexplored integral approach to CLBP through exercises. In contrast to commonly used exercise programs, the integral program does not include specific local strength exercises for hip and trunk flexors and extensors. However, learning dynamic trunk muscle control in various body positions with added limb movements could be beneficial because of the parallels to everyday work. The study will contribute to clinical practice by providing evidence to guide professionals when deciding for the proper and efficient treatment of patients with CLBP. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03623802 . Registered on 9th August 2018.

SUBMITTER: Pustivsek S

PROVIDER: S-EPMC6340171 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Project description:IntroductionLow back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.Methods and analysisPragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ?6 weeks ago for this episode of LBP; average LBP intensity of ?4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .Ethics and disseminationApproved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Project description:IntroductionLow back pain is a common problem and a substantial source of morbidity and disability worldwide. Patients frequently visit the emergency department (ED) for low back pain, but many experience persistent symptoms at 3 months despite frequent receipt of opioids. Although physical therapy interventions have been demonstrated to improve patient functioning in the outpatient setting, no randomised trial has yet to evaluate physical therapy in the ED setting.Methods and analysisThis is a single-centre cluster-randomised trial of an embedded ED physical therapy intervention for acute low back pain. We used a covariate-constrained approach to randomise individual physicians (clusters) at an urban academic ED in Chicago, Illinois, USA, to receive, or not receive, an embedded physical therapist on their primary treatment team to evaluate all patients with low back pain. We will then enrol individual ED patients with acute low back pain and allocate them to the embedded physical therapy or usual care study arms, depending on the randomisation assignment of their treating physician. We will follow patients to a primary endpoint of 3 months and compare a primary outcome of change in PROMIS-Pain Interference score and secondary outcomes of change in modified Oswestry Disability Index score and patient-reported opioid use. Our primary approach will be a modified intention-to-treat analysis, whereby all participants who complete at least one follow-up data time point will be included in analyses, regardless of their or their physicians' adherence to their assigned study arm.Ethics and disseminationThis trial is funded by the US Agency for Healthcare Research and Quality (R01HS027426) and was approved by the Northwestern University Institutional Review Board. All physician and patient participants will give written informed consent to study participation. Trial results will be submitted for presentation at scientific meetings and for publication in peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT04921449).

Project description:BackgroundInterventions for low back pain (LBP) commonly target 'dysfunctional' or atypical lumbo-pelvic kinematics in the belief that correcting aberrant movement improves patients' pain and activity outcomes. If atypical kinematic parameters and postures have a relationship to LBP, they could be expected to more prevalent in people with LBP compared to people without LBP (NoLBP). This exploratory study measured, defined and compared atypical kinematic parameters in people with and without LBP.MethodsWireless inertial motion and EMG sensors were used to measure lumbo-pelvic kinematics during standing trunk flexion (range of motion (ROM), timing, sequence coordination, and extensor muscle activation) and in sitting (relative sitting position, pelvic tilt range) in a sample of 126 of adults without LBP and 140 chronic LBP subjects. Atypical movement was defined using the 10th/90th centiles of the NoLBP group. Mean differences and prevalence rates for atypical movement were calculated. Dichotomised pain scores for 'high-pain-on-bending' and 'high-pain-on-sitting' were tested for their association with atypical kinematic variables.ResultsFor standing flexion, significant mean differences, after adjusting for age and gender factors, were seen for the LBP group with (i) reduced ROM (trunk flexion (NoLBP 111o, LBP 93o, p < .0001), lumbar flexion (NoLBP 52o, LBP 46o, p < .0001), pelvic flexion (NoLBP 59o, LBP 48o, p < .0001), (ii) greater extensor muscle activation for the LBP group (NoLBP 0.012, LBP 0.25 p < .0001), (iii) a greater delay in pelvic motion at the onset of flexion (NoLBP - 0.21 s; LBP - 0.36 s, p = 0.023), (iv) and longer movement duration for the LBP group (NoLBP 2.28 s; LBP 3.18 s, p < .0001). Atypical movement was significantly more prevalent in the LBP group for small trunk (× 5.4), lumbar (× 3.0) and pelvic ROM (× 3.9), low FRR (× 4.9), delayed pelvic motion at 20o flexion (× 2.9), and longer movement duration (× 4.7). No differences between groups were seen for any sitting parameters. High pain intensity was significantly associated with small lumbar ROM and pelvic ROM.ConclusionSignificant movement differences during flexion were seen in people with LBP, with a higher prevalence of small ROM, slower movement, delayed pelvic movement and greater lumbar extensor muscle activation but without differences for any sitting parameter.

Project description:IntroductionThe need for an interdisciplinary multimodal approach to the treatment of back pain has already been demonstrated by various studies. However, when considering the periods of incapacity to work in the longitudinal course after the multimodal pain therapy (MPT), limits in terms of its sustainable effect become clear. Patients who receive MPT subsequently return to standard outpatient care, which is associated with a risk of relapse. A 12-month relapse prophylaxis (RP) programme, intended to follow a 4-week MPT, was developed to help patients make the transition to health-conscious and physically active behaviour in everyday life and to identify and prevent impending relapses at an early stage. The evaluation, based on a cluster randomised controlled trial, seeks to provide information on the benefits of early and intensive RP as part of MPT, examine whether it is cost effective, reduces the days of incapacity to work and increases functional capacity, as well as to examine other parameters.Methods and analysisThe study population comprises members of a regional statutory health insurance fund in Germany, who are ≤62 years old, gainfully employed and have been incapacitated for work for at least 21 days due to a diagnosis of back pain. Over a recruitment period of 24 months, a maximum of 368 individuals can potentially be included in the MPT. The intervention group (IG) and control group (CG) will both receive MPT, after randomisation IG will receive RP and CG will receive no further therapy or support as part of the trial. The evaluation is carried out on the following levels: structural, process and results quality. Cost effectiveness is also assessed by means of a health economic evaluation. In addition to the collection of qualitative and quantitative primary data, claims data from the regional health insurance fund are also included in the analysis.Ethics and disseminationThis study has received approval by the ethics committee of the Hannover Medical School (reference number: 8548_BO_S_2019). The study results will be disseminated in national and international journals and conference presentations.Trial registration numberDRKS00017654.

Project description:ObjectiveTo identify suggestions for future research on spinal movement variability (SMV) in individuals with low back pain (LBP) by investigating (1) the methodologies and statistical tools used to assess SMV; (2) characteristics that influence the direction of change in SMV; (3) the methodological quality and potential biases in the published studies; and (4) strategies for optimizing SMV in LBP patients.MethodsWe searched literature databases (CENTRAL, Medline, PubMed, Embase, and CINAHL) and comprehensively reviewed the relevant papers up to 5 May 2020. Eligibility criteria included studies investigating SMV in LBP subjects by measuring trunk angle using motion capture devices during voluntary repeated trunk movements in any plane. The Newcastle-Ottawa risk of bias tool was used for data quality assessment. Results were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews.ResultsEighteen studies were included: 14 cross-sectional and 4 prospective studies. Seven linear and non-linear statistical tools were used. Common movement tasks included trunk forward bending and backward return, and object lifting. Study results on SMV changes associated with LBP were inconsistent. Two of the three interventional studies reported changes in SMV, one of which was a randomized controlled trial (RCT) involving neuromuscular exercise interventions. Many studies did not account for the potential risk of selection bias in the LBP population.ConclusionDesigners of future studies should recognize that each of the two types of statistical tools assesses functionally different aspects of SMV. Future studies should also consider dividing participants into subgroups according to LBP characteristics, as three potential subgroups with different SMV characteristics were proposed in our study. Different task demands also produced different effects. We found preliminary evidence in a RCT that neuromuscular exercises could modify SMV, suggesting a rationale for well-designed RCTs involving neuromuscular exercise interventions in future studies.

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Integral movement therapy versus local movement therapy approach in patients with idiopathic chronic low-back pain: study protocol for a randomized controlled trial.

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