Dataset Information

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Low 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 analysis

Pragmatic, 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 dissemination

Approved 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 number

Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

SUBMITTER: Kent P

PROVIDER: S-EPMC6701662 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

Kent Peter P O'Sullivan P P Smith Anne A Haines Terry T Campbell Amity A McGregor Alison H AH Hartvigsen Jan J O'Sullivan Kieran K Vickery Alistair A Caneiro J P JP Schütze Robert R Laird Robert A RA Attwell Stephanie S Hancock Mark M

BMJ open 20190818 8

<h4>Introduction</h4>Low 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 ...[more]

PMID: 31427344

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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:BackgroundMovement and posture are commonly believed to relate to low back pain (LBP). Yet, we know little about how people make sense of the relationship between their LBP, movement and posture, particularly after recovery. We aimed to qualitatively explore this understanding, how it changes and how it relates to quantitative changes.MethodsA mixed method study in the context of an existing single-case design involving 12 people with disabling non-specific LBP. Interviews were conducted before and after a 12-week physiotherapy-led Cognitive Functional Therapy intervention, and qualitative findings from these were integrated with individualized, quantitative measures of movement, posture, psychological factors, pain and activity limitation.ResultsStrong beliefs about movement and posture were identified during the baseline interviews. Lived experiences of tension and stiffness characterized the embodiment of 'nonconscious protection', while healthcare and societal messages prompted pain-related fear and 'conscious protection'. Through varied journeys, most participants reported improvements over time with less protective movement and postural strategies. For some, being less protective required focused attention ('conscious non-protection'), but most returned to automatic, normal and fearless patterns ('nonconscious non-protection'), forgetting about their LBP. One participant reported no meaningful shift, remaining protective. Greater spinal range, faster movement, more relaxed postures and less back muscle EMG accompanied positive changes in self-report factors.ConclusionThe findings offer a framework for understanding how people make sense of movement and posture during the process of recovery from persistent, disabling non-specific LBP. This involved a re-conceptualisation of movement and posture, from threatening, to therapeutic.SignificanceFindings from qualitative interviews before and after a Cognitive Functional Therapy intervention in 12 people with disabling low back pain highlighted an individualized recovery journey from conscious and nonconscious protection to conscious non-protection for some, and nonconscious non-protection for many. Pre and post-quantitative measures of movement, posture, psychological factors, pain and activity limitation integrated well with the qualitative findings. The findings suggest movement and posture may form part of a multidimensional pain schema.

Project description:BackgroundThe aims of this pilot trial were to (i) test the hypothesis that modifying patterns of painful lumbo-pelvic movement using motion-sensor biofeedback in people with low back pain would lead to reduced pain and activity limitation compared with guidelines-based care, and (ii) facilitate sample size calculations for a fully powered trial.MethodsA multicentre (8 clinics), cluster-randomised, placebo-controlled pilot trial compared two groups of patients seeking medical or physiotherapy primary care for sub-acute and chronic back pain. It was powered for longitudinal analysis, but not for adjusted single-time point comparisons. The intervention group (n = 58) received modification of movement patterns augmented by motion-sensor movement biofeedback (ViMove, dorsaVi.com) plus guidelines-based medical or physiotherapy care. The control group (n = 54) received a placebo (wearing the motion-sensors without biofeedback) plus guidelines-based medical or physiotherapy care. Primary outcomes were self-reported pain intensity (VAS) and activity limitation (Roland Morris Disability Questionnaire (RMDQ), Patient Specific Functional Scale (PSFS)), all on 0-100 scales. Both groups received 6-8 treatment sessions. Outcomes were measured seven times during 10-weeks of treatment and at 12, 26 and 52 week follow-up, with 17.0 % dropout. Patients were not informed of group allocation or the study hypothesis.ResultsAcross one-year, there were significant between-group differences favouring the intervention group [generalized linear model coefficient (95 % CI): group effect RMDQ -7.1 (95 % CI-12.6;-1.6), PSFS -10.3 (-16.6; -3.9), QVAS -7.7 (-13.0; -2.4); and group by time effect differences (per 100 days) RMDQ -3.5 (-5.2; -2.2), PSFS -4.7 (-7.0; -2.5), QVAS -4.8 (-6.1; -3.5)], all p < 0.001. Risk ratios between groups of probability of improving by >30 % at 12-months = RMDQ 2.4 (95 % CI 1.5; 4.1), PSFS 2.5 (1.5; 4.0), QVAS 3.3 (1.8; 5.9). The only device-related side-effects involved transient skin irritation from tape used to mount motion sensors.ConclusionsIndividualised movement retraining using motion-sensor biofeedback resulted in significant and sustained improvements in pain and activity limitation that persisted after treatment finished. This pilot trial also refined the procedures and sample size requirements for a fully powered RCT. This trial (Australian New Zealand Clinical Trials Registry NCT01572779) was equally funded by dorsaVi P/L and the Victorian State Government.

Project description:ObjectiveThe aim of this study was to assess the feasibility and potential effectiveness of an 8-week virtual EMG biofeedback intervention for patients with CLBP.MethodsPatients with CLBP completed validated baseline and post-intervention assessments of pain intensity and interference (Brief Pain Inventory), back pain-related disability (Oswestry Disability Index), anxiety and depression (Hospital Anxiety and Depression Scale). Participants underwent a series of Quantitative Sensory Testing (QST) procedures assessing responses to mechanical stimuli during two separate visits (baseline and post-intervention). In addition, we assessed, using surface EMG, the muscle tension in the trapezius, latissimus, and low back muscles at each session. Patients were randomized into the EMG biofeedback intervention or usual care group. Factorial analysis of variance including the interaction between treatment group and time was used to analyze the changes in pain intensity (primary outcome), pain interference, disability (secondary outcomes), anxiety, and depression (secondary outcomes).ResultsCompared to the treatment as usual comparison group, patients in the EMG biofeedback group reported lower pain intensity after completing the intervention (mean group difference 0.9, 95% CI -1.07, -0.32; p≤0.01). Compared to baseline, participants in the EMG biofeedback group demonstrated statistically significant reductions in pain interference (mean difference 1.3, 95% CI 0.42, 2.1; p≤0.01), disability (mean difference 4.32, 95% CI 1.2, 7.3; p≤0.01), and significant increases in low back pain thresholds (mean difference 0.5, 95% CI -0.87, -0.05; p≤0.01), assessed by QST. However, no significant group by time effects were observed for secondary outcomes: pain interference, disability, and low back pain thresholds. In addition, significant changes were observed in muscle tension for the trapezius, latissimus, and low back muscles in the EMG biofeedback group (p<0.001).ConclusionsVirtual EMG biofeedback shows promise as a potential therapy for reducing pain and disability in individuals with chronic nonspecific low back pain.

Project description:BackgroundLow back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain.MethodsEligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.DiscussionDespite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible.Trial registrationClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.

Project description:BACKGROUND:Improving movement control can be an important treatment goal for patients with chronic low back pain (CLBP). Although external feedback is essential when learning new movement skills, many aspects of feedback provision in patients with CLBP remain currently unexplored. New rehabilitation technologies, such as movement sensors, are able to provide reliable and accurate feedback. As such, they might be more effective than conventional feedback for improving movement control. The aims of this study were (1) to assess whether sensor-based feedback is more effective to improve lumbopelvic movement control compared to feedback from a mirror or no feedback in patients with chronic low back pain (CLBP), and (2) to evaluate whether patients with CLBP are equally capable of improving lumbopelvic movement control compared to healthy persons. METHODS:Fifty-four healthy participants and 54 patients with chronic non-specific LBP were recruited. Both participant groups were randomised into three subgroups. During a single exercise session, subgroups practised a lumbopelvic movement control task while receiving a different type of feedback, i.e. feedback from movement sensors, from a mirror or no feedback (=control group). Kinematic measurements of the lumbar spine and hip were obtained at baseline, during and immediately after the intervention to evaluate the improvements in movement control on the practised task (assessment of performance) and on a transfer task (assessment of motor learning). RESULTS:Sensor-based feedback was more effective than feedback from a mirror (p?<?0.0001) and no feedback (p?<?0.0001) to improve lumbopelvic movement control performance (Sensor vs. Mirror estimated difference 9.9° (95% CI 6.1°-13.7°), Sensor vs. Control estimated difference 10.6° (95% CI 6.8°-14.3°)) and motor learning (Sensor vs. Mirror estimated difference 7.2° (95% CI 3.8°-10.6°), Sensor vs. Control estimated difference 6.9° (95% CI 3.5°-10.2°)). Patients with CLBP were equally capable of improving lumbopelvic movement control compared to healthy persons. CONCLUSIONS:Sensor-based feedback is an effective means to improve lumbopelvic movement control in patients with CLBP. Future research should focus on the long-term retention effects of sensor-based feedback. TRIAL REGISTRATION:clinicaltrials.gov NCT02773160 , (retrospectively registered on May 16th, 2016).

Project description:BACKGROUND:Chiropractic care is a popular alternative for back and neck pain, with efficacy comparable to usual care in randomized trials. However, the effectiveness of chiropractic care as delivered through conventional care settings remains largely unexplored. OBJECTIVE:To evaluate the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. STUDY DESIGN:Prospective cohort study using propensity score-matched controls. PARTICIPANTS:Using retrospective electronic health record data, we developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. MAIN MEASURES:Main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care. KEY RESULTS:Both groups' (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. (severity - 0.10 (95% CI - 0.30, 0.10), interference - 0.07 (- 0.31, 0.16), bothersomeness - 0.1 (- 0.39, 0.19)). After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group ($1996 [SD = 3874] vs $1086 [SD = 1212], p = .034). Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072). CONCLUSIONS:We found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

Dataset Information

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

Similar Datasets

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