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Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting.

ABSTRACT: The general population has a pessimistic view of low back pain (LBP), and evidence-based information has been used to positively influence LBP beliefs in previously reported mass media studies. However, there is a lack of randomized trials investigating whether LBP beliefs can be modified in primary prevention settings. This cluster randomized clinical trial investigated the effect of an evidence-based psychosocial educational program (PSEP) on LBP beliefs for soldiers completing military training. A military setting was selected for this clinical trial, because LBP is a common cause of soldier disability. Companies of soldiers (n = 3,792) were recruited, and cluster randomized to receive a PSEP or no education (control group, CG). The PSEP consisted of an interactive seminar, and soldiers were issued the Back Book for reference material. The primary outcome measure was the back beliefs questionnaire (BBQ), which assesses inevitable consequences of and ability to cope with LBP. The BBQ was administered before randomization and 12 weeks later. A linear mixed model was fitted for the BBQ at the 12-week follow-up, and a generalized linear mixed model was fitted for the dichotomous outcomes on BBQ change of greater than two points. Sensitivity analyses were performed to account for drop out. BBQ scores (potential range: 9-45) improved significantly from baseline of 25.6 +/- 5.7 (mean +/- SD) to 26.9 +/- 6.2 for those receiving the PSEP, while there was a significant decline from 26.1 +/- 5.7 to 25.6 +/- 6.0 for those in the CG. The adjusted mean BBQ score at follow-up for those receiving the PSEP was 1.49 points higher than those in the CG (P < 0.0001). The adjusted odds ratio of BBQ improvement of greater than two points for those receiving the PSEP was 1.51 (95% CI = 1.22-1.86) times that of those in the CG. BBQ improvement was also mildly associated with race and college education. Sensitivity analyses suggested minimal influence of drop out. In conclusion, soldiers that received the PSEP had an improvement in their beliefs related to the inevitable consequences of and ability to cope with LBP. This is the first randomized trial to show positive influence on LBP beliefs in a primary prevention setting, and these findings have potentially important public health implications for prevention of LBP.

SUBMITTER: George SZ

PROVIDER: S-EPMC2899593 | biostudies-literature | 2009 Jul

REPOSITORIES: biostudies-literature

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Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting.

George Steven Z SZ Teyhen Deydre S DS Wu Samuel S SS Wright Alison C AC Dugan Jessica L JL Yang Guijun G Robinson Michael E ME Childs John D JD

European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 20090506 7

The general population has a pessimistic view of low back pain (LBP), and evidence-based information has been used to positively influence LBP beliefs in previously reported mass media studies. However, there is a lack of randomized trials investigating whether LBP beliefs can be modified in primary prevention settings. This cluster randomized clinical trial investigated the effect of an evidence-based psychosocial educational program (PSEP) on LBP beliefs for soldiers completing military traini ...[more]

PMID: 19418075

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Project description:Effective strategies for the primary prevention of low back pain (LBP) remain elusive with few large-scale clinical trials investigating exercise and education approaches. The purpose of this trial was to determine whether core stabilization alone or in combination with psychosocial education prevented incidence of low back pain in comparison to traditional lumbar exercise.The Prevention of Low Back Pain in the Military study was a cluster randomized clinical study with four intervention arms and a two-year follow-up. Participants were recruited from a military training setting from 2007 to 2008. Soldiers in 20 consecutive companies were considered for eligibility (n = 7,616). Of those, 1,741 were ineligible and 1,550 were eligible but refused participation. For the 4,325 Soldiers enrolled with no previous history of LBP average age was 22.0 years (SD = 4.2) and there were 3,082 males (71.3%). Companies were randomly assigned to receive traditional lumbar exercise, traditional lumbar exercise with psychosocial education, core stabilization exercise, or core stabilization with psychosocial education, The psychosocial education session occurred during one session and the exercise programs were done daily for 5 minutes over 12 weeks. The primary outcome for this trial was incidence of low back pain resulting in the seeking of health care.There were no adverse events reported. Evaluable patient analysis (4,147/4,325 provided data) indicated no differences in low back incidence resulting in the seeking of health care between those receiving the traditional exercise and core stabilization exercise programs. However, brief psychosocial education prevented low back pain episodes regardless of the assigned exercise approach, resulting in a 3.3% (95% CI: 1.1 to 5.5%) decrease over two years (numbers needed to treat (NNT) = 30.3, 95% CI = 18.2 to 90.9).Core stabilization has been advocated as preventative, but offered no such benefit when compared to traditional lumbar exercise in this trial. Instead, a brief psychosocial education program that reduced fear and threat of low back pain decreased incidence of low back pain resulting in the seeking of health care. Since this trial was conducted in a military setting, future studies are necessary to determine if these findings can be translated into civilian populations.NCT00373009 at ClinicalTrials.gov - http://clinicaltrials.gov/

Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.

Project description:ObjectivesTo assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients' back pain beliefs, and in decreasing disability and absenteeism.DesignStepped-wedge cluster randomised trial with parallel economic evaluation.SettingDutch primary healthcare.ParticipantsPatients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).InterventionsThe intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.Primary and secondary outcome measuresThe primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.ResultsThere were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70- and the societal cost difference was €535-in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).ConclusionsA multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.Trial registration numberNTR4329.

Project description:The purpose of this secondary analysis was to test the hypothesis that an empirically derived psychological subgrouping scheme based on multiple Fear-Avoidance Model (FAM) constructs would provide additional capabilities for clinical outcomes in comparison with a single FAM construct.Patients (n=108) with acute or subacute low back pain enrolled in a clinical trial comparing behavioral physical therapy interventions to classification-based physical therapy completed baseline questionnaires for Pain Catastrophizing Scale, fear-avoidance beliefs [Fear-Avoidance Beliefs Questionnaire (FABQ)-physical activity scale (PA), FABQ work scale], and patient-specific fear (Fear of Daily Activities Questionnaire). Clinical outcomes included pain intensity and disability measured at baseline, 4 weeks, and 6 months. A hierarchical agglomerative cluster analysis was used to create distinct cluster profiles among the FAM measures and discriminant analysis was used to interpret clusters. Changes in clinical outcomes were investigated with repeated measures analysis of variance and differences in results based on cluster membership were compared with FABQ-PA subgrouping used in the original trial.Three distinct FAM subgroups (Low-Risk, High Specific Fear, and High Fear and Catastrophizing) emerged from cluster analysis. Subgroups differed on baseline pain and disability (P<0.01) with the High Fear and Catastrophizing subgroup associated with greater pain than the Low-Risk subgroup (P<0.01) and the greatest disability (P<0.05). Subgroup×time interactions were detected for both pain and disability (P<0.05) with the High Fear and Catastrophizing subgroup reporting greater changes in pain and disability than other subgroups (P<0.05). In contrast, FABQ-PA subgroups used in the original trial were not associated with interactions for clinical outcomes.These data suggest that subgrouping based on multiple FAM measures may provide additional information on clinical outcomes in comparison with determining subgroup status by FABQ-PA alone. Subgrouping methods for patients with low back pain should include multiple psychological factors to further explore if patients can be matched with appropriate interventions.

Project description:Low back pain (LBP) is a chronic disorder which exerts a profound impact on various spheres of psychosocial functioning, including emotional distress, functional limitations and decrements in social contacts. The objective of this study was to investigate the associations between the indices of psychosocial functioning in patients with chronic LBP and a range of psychological factors. Specifically, the study aimed at exploring the relative participation of personality, social support, disease-related cognitive appraisals and coping styles in accounting for the differences in psychosocial functioning of patients with LBP. One-hundred-twenty patients with LBP took part in the study and completed a battery of psychological questionnaires: NEO-Five Factors Inventory, Ways of Coping Questionnaire, Disease-Related Social Support Scale, Disease-Related Appraisals Scale and Psychosocial Functioning Questionnaire (PFQ). The PFQ dimensions were used as dependent variables in a series of stepwise regression analysis models with the scores from other questionnaires entered as independent variables. A cognitive appraisal of the disease in terms of an obstacle was strongly related to all domains of functioning; however, other appraisals (threat, challenge, harm, profit and overall disease importance) were uniquely associated with particular domains of functioning. Deprivation of social support was a significant predictor of distress experienced in interpersonal context and of sense of being disabled. Among basic personality traits, agreeableness was negatively associated with distress in interpersonal context, and conscientiousness was positively related to acceptance of life with the disease. Problem-focus coping was linked to higher acceptance of life with the disease. Among sociodemographic variables, older age and lower educational level were related to greater subjective feelings of being disabled. Pain severity was found unrelated to any of psychosocial functioning domains. Different aspects of psychosocial functioning are best accounted for by diverse patterns of psychological factors, which suggests involvement of different psychological mechanisms in development of LBP-related disability.

Project description:BackgroundInappropriate imaging and low-value care for low back pain (LBP) are common. A new patient-education booklet was created to overcome identified barriers to the delivery of recommended care, including the use of inappropriate imaging. Our aim was to assess the effectiveness of this booklet as part of primary care for LBP patients in comparison to usual care.MethodsA cluster-randomized trial was performed. The intervention involved providing practitioners with the new patient-education booklet and a 30-min training session on its use. The booklet was provided during the clinical consult to all consenting LBP patients in the intervention group. Primary outcomes were the proportion of patients presenting with LBP who underwent imaging examinations during the first three months of follow-up and PROMIS PF-20 (Patient-Reported Outcomes Measurement Information System, 20-item physical functioning short form) change between baseline and three-month follow-up. Secondary outcomes, including sick leave and imaging examinations at 12 months, were investigated. Logistic regression using GEE-estimation was used for dichotomous outcomes, Poisson regression using GEE-estimation for count outcomes, and linear mixed models for continuous outcomes.ResultsUsing the patient education booklet appeared to substantially reduce the proportion of LBP patients who underwent an imaging examination at three months, but the result was not statistically significant (OR 0.57, 95% confidence interval (Cl) 0.27 to 1.22). At 12 months, the effect was slightly larger and statistically significant (OR 0.50, 95%Cl 0.30 to 0.83, p = 0.008). No difference was observed in the PROMIS PF-20 T-score change between baseline and 3 months or 12 months (p = 0.365 and p = 0.923, respectively). The number of sick leave days in the intervention group was less than that in the control group at 3 months (RR 0.47, 95%Cl 0.26 to 0.83, p = 0.010) and at 12 months (RR 0.36, 95%Cl 0.18 to 0.72, p = 0.004).ConclusionsThe booklet appeared to be effective in reducing the proportion of LBP patients who underwent imaging examinations over 12 months. The intervention had no discernible effect on the PROMIS PF20 T-score change. The number of sick leave days was substantially lower in the intervention group.Trial registrationISRCTN, ISRCTN14389368 , Registered 4 April 2019-Retrospectively registered.

Project description:Low back pain (LBP) is the leading cause of disability worldwide. Evidence pointing towards a more efficacious model of care using a biopsychosocial approach for LBP management highlights the need to understand the pain-related beliefs of patients and those who treat them. The beliefs held by healthcare professionals (HCPs) are known to influence the treatment advice given to patients and consequently management outcomes. Back pain beliefs are known to be influenced by factors such as culture, education, health literacy, place of work, personal experience of LBP and the sequelae of LBP such as disability. There is currently a knowledge gap among these relationships in non-western countries. The aim of this study was to examine the associations between LBP-related beliefs among Chinese HCPs and characteristics of these HCPs.A convenience sample of 432 HCPs working in various health settings in Shanghai, China, completed a series of questionnaires assessing their demographic characteristics, LBP status, pain-related disability and their beliefs about their own LBP experience, using the Back beliefs Questionnaire (BBQ) and the Fear Avoidance Beliefs Questionnaire (FABQ).Younger Chinese HCPs (20-29 years) held more negative beliefs and attitudes related to LBP compared to older HCPs (>40years; BBQ mean difference [95% CI]: 2.4 [0.9 - 3.9], p = 0.001). HCPs working outside tertiary hospitals had poorer beliefs concerning the inevitable consequences of LBP (BBQ mean difference [95% CI]: -2.4 [-3.8 - -1.0], p = 0.001). HCPs who experienced LBP had higher level of fear avoidance beliefs when experiencing high LBP-related disability (FABQ-physical mean difference [95% CI]: 2.8 [1.5 - 4.1], p < 0.001; FABQ-work mean difference [95% CI]: 6.2 [4.0 - 8.4], p < 0.001)) and had lower level of fear avoidance beliefs if they had completed postgraduate study (FABQ-physical mean difference [95% CI]: 2.9 [-5.8 - 0.0], p = 0.049).This study suggests that LBP-related beliefs and attitudes among Chinese HCPs are influenced by age, location of work, level of LBP-related disability and education level. Understanding back pain beliefs of Chinese HCPs forms an important foundation for future studies into the condition and its management in China.

Dataset Information

Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting.

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Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting.

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