INTRODUCTION: In an earlier study, Gatchel et al. (J Occup Rehabil 13:1–9, 2003) demonstrated that participants at high risk for developing chronic low back pain disability (CLBPD), who received a biopsychosocial early intervention treatment program, displayed significantly more symptom improvement, as well as cost savings, relative to participants receiving standard care. The purpose of the present study was to expand on these results by examining whether the addition of a work-transition component would further strengthen the effectiveness of this early intervention treatment. METHODS: Using an existing algorithm, participants were identified as being high-risk (HR) or low-risk (LR) for developing CLBPD. HR participants were then randomly assigned to one of three groups: early intervention (EI); early intervention with work transition (EI/WT); or standard care (SC). Participants provided information regarding pain, disability, work status, and psychosocial functioning at baseline, periodically during treatment, and again 1 year following completion of treatment. RESULTS: At 1-year followup, no significant differences were found between the EI and EI/WT groups in terms of occupational status, self-reports of pain and disability, coping ability or psychosocial functioning. However, significant differences in all these outcomes were found comparing these groups to standard care. CONCLUSION: The addition of a work transition component to an early intervention program for the treatment of ALBP did not significantly contribute to improved work outcomes. However, results further support the effectiveness of early intervention for high-risk ALBP patients. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
BACKGROUND: Advice and exercise are widely recommended for subacute low back pain, but the effectiveness of these interventions is unclear.
OBJECTIVE: To investigate the effectiveness of physiotherapist-prescribed exercise, advice, or both for subacute low back pain.
DESIGN: Factorial randomized, placebo-controlled trial.
SETTING: 7 university hospitals and primary care clinics in Australia and New Zealand.
PATIENTS: 259 persons with subacute low back pain (>6 weeks and <3 months in duration).
INTERVENTION: Participants received 12 physiotherapist-directed exercise or sham exercise sessions and 3 physiotherapist-directed advice or sham advice sessions over 6 weeks.
MEASUREMENTS: Primary outcomes were average pain over the past week (scale, 0 to 10), function (Patient-Specific Functional Scale), and global perceived effect (11-point scale) at 6 weeks and 12 months. Secondary outcomes were disability (Roland-Morris Disability Questionnaire), number of health care contacts, and depression (Depression Anxiety Stress Scales-21).
RESULTS: Exercise and advice were each slightly more effective than placebo at 6 weeks but not at 12 months. The effect of advice on the pain scale was -0.7 point (95% CI, -1.2 to -0.2 point; P = 0.011) at 6 weeks and -0.4 point (CI, -1.0 to 0.3 point; P = 0.27) at 12 months, whereras the effect of exercise was -0.8 point (CI, -1.3 to -0.3 point; P = 0.004) at 6 weeks and -0.5 point (CI, -1.1 to 0.2 point; P = 0.14) at 12 months. The effect of advice on the function scale was 0.7 point (CI, 0.1 to 1.3 points; P = 0.014) at 6 weeks and 0.6 point (CI, 0.1 to 1.2 points; P = 0.023) at 12 months, and the effect of exercise was 0.4 point (CI, -0.2 to 1.0 point; P = 0.174) at 6 weeks and 0.5 point (CI, -0.1 to 1.0 point; P = 0.094) at 12 months. The effect of advice on the global perceived effect scale was 0.8 point (CI, 0.3 to 1.2 points; P < 0.001) at 6 weeks and 0.3 point (CI, -0.2 to 0.9 point; P = 0.24) at 12 months, and the effect of exercise was 0.5 point (CI, 0.1 to 1.0 point; P = 0.017) at 6 weeks and 0.4 point (CI, -0.1 to 1.0 point; P = 0.134) at 12 months. When administered together, exercise and advice had larger effects on all outcomes at 6 weeks (effect on pain, -1.5 [CI -2.2 to -0.7 point; P = 0.001], with similar results for other primary outcomes); however, by 12 months, there was a statistically significant effect only for function (effect, 1.1 points [CI, 0.3 to 1.8 points]; P = 0.005).
LIMITATION: Physiotherapists were not blinded.
CONCLUSIONS: In participants with subacute low back pain, physiotherapist-directed exercise and advice were each slightly more effective than placebo at 6 weeks. The effect was greatest when the interventions were combined. At 12 months, the only effect that persisted was a small effect on participant-reported function. AUSTRALIAN CLINICAL TRIALS REGISTRY REGISTRATION NUMBER: 12605000039684.
OBJECTIVE: Mass-media campaigns have been known to modify the outcome of low back pain (LBP). We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP. METHODS: Design: A 3-month pragmatic, multicenter controlled trial with geographic stratification. Setting: Primary care practice in France. Participants: 2752 patients with acute LBP. Intervention: An advice book on LBP (the "back book"). Main outcome measures: The main outcome measure was persistence of LBP three months after baseline evaluation. RESULTS: 2337 (85%) patients were assessed at follow-up and 12.4% of participants reported persistent LBP. The absolute risk reduction of reporting persistent back pain in the intervention group was 3.6% lower than in the control group (10.5% vs. 14.1%; 95% confidence interval [-6.3% ; -1.0%]; p value adjusted for cluster effect = 0.01). Patients in the intervention group were more satisfied than those in the control group with the information they received about physical activities, when to consult their physician, and how to prevent a new episode of LBP. However, the number of patients who had taken sick leave was similar, as was the mean sick-leave duration, in both arms, and, among patients with persistent pain at follow-up, the intervention and control groups did not differ in disability or fear-avoidance beliefs. CONCLUSIONS: The level of improvement of an information booklet is modest, but the cost and complexity of the intervention is minimal. Therefore, the implications and generalizability of this intervention are substantial. TRIAL REGISTRATION: ClinicalTrials.gov NCT00343057.
BACKGROUND: Recommendations for the management of low back pain in primary care emphasise the importance of recognising and addressing psychosocial factors at an early stage. We compared the effectiveness of a brief pain-management programme with physiotherapy incorporating manual therapy for the reduction of disability at 12 months in patients consulting primary care with subacute low back pain.
METHODS: For this pragmatic, multicentre, randomised clinical trial, eligible participants consulted primary care with non-specific low back pain of less than 12 weeks' duration. They were randomly assigned either a programme of pain management (n=201) or manual therapy (n=201). The primary outcome was change in the score on the Roland and Morris disability questionnaire at 12 months. Analysis was by intention to treat.
FINDINGS: Of 544 patients assessed for eligibility, 402 were recruited (mean age 40.6 years) and 329 (82%) reached 12-month follow-up. Mean disability scores were 13.8 (SD 4.8) for the pain-management group and 13.3 (4.9) for the manual-therapy group. The mean decreases in disability scores were 8.8 (6.4) and 8.8 (6.1) at 12 months (difference 0 [95% CI -1.3 to 1.4], p=0.99), and median numbers of physiotherapy visits per patient were three (IQR one to five) and four (two to five), respectively (p=0.001). One adverse reaction (an exacerbation of pain after the initial assessment) was recorded.
INTERPRETATION: Brief pain management techniques delivered by appropriately trained clinicians offer an alternative to physiotherapy incorporating manual therapy and could provide a more efficient first-line approach for management of non-specific subacute low back pain in primary care.
OBJECTIVE: To compare the effects of a minimal intervention strategy aimed at assessment and modification of psychosocial prognostic factors and usual care for treatment of (sub)acute low back pain in general practice. DESIGN: Cluster randomised clinical trial. SETTING: 60 general practitioners in 41 general practices. Participants: 314 patients with non-specific low back pain of less than 12 weeks' duration, recruited by their general practitioner. INTERVENTIONS: In the minimal intervention strategy group the general practitioner explored the presence of psychosocial prognostic factors, discussed these factors, set specific goals for reactivation, and provided an educational booklet. The consultation took about 20 minutes. Usual care was not standardised. Main outcome measures: Functional disability (Roland-Morris disability questionnaire), perceived recovery, and sick leave because of low back pain assessed at baseline and after 6, 13, 26, and 52 weeks. RESULTS: The dropout rate was 8% in the minimal intervention strategy group and 9% in the usual care group. Multilevel analyses showed no significant differences between the groups on any outcome measure during 12 months of follow-up in the whole group or in relevant subgroups (patients with high scores on psychosocial measures at baseline or a history of frequent or prolonged low back pain). CONCLUSION: This study provides no evidence that (Dutch) general practitioners should adopt our new treatment strategy aimed at psychosocial prognostic factors in patients with (sub)acute low back pain. Further research should examine why our new strategy was not more effective than usual care. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
BACKGROUND: We evaluated the effect of a self-management program for low-income primary care patients with acute low back pain (ALBP) from inner-city neighborhood health centers.
METHODS: We conducted a randomized controlled trial of a self-management program compared with usual care at university-affiliated neighborhood health centers and an emergency department of an inner-city public teaching hospital. We enrolled 211 patients who visited a physician for ALBP (<90 days' duration). The self-management program consisted of 3 group sessions and telephone follow-up that focused on understanding back pain, increasing physical activity, and dealing with fears and frustrations.
RESULTS: At baseline, 4 months, and 12 months, blinded interviewers assessed back pain physical function (Roland Disability Questionnaire), health status (Arthritis Impact Measurement Scales), self-efficacy, and time spent in physical activity. Compared with patients receiving usual care, intervention patients reported significantly better scores on the Roland Disability Questionnaire (P =.009), mental functioning (P =.009), self-efficacy to manage ALBP (P =.03), time spent in physical activity (P =.047), and reduced fears of movement/reinjury (P =.005) after 12 months.
CONCLUSION: A self-management program can improve and maintain functional status, mental functioning, and self-efficacy to manage future symptoms for 1 year among primary care patients with ALBP living in the urban, inner city.
Study Design. A randomized clinical trial with 4-week and 6-month follow-up periods. Objective. To compare the effect of a fear-avoidance-based physical therapy intervention with standard care physical therapy for patients with acute low back pain. Summary of Background Data. The disability reduction strategy of secondary prevention involves providing specific treatment for patients that are likely to have chronic disability from low back pain. Previous studies have indicated that elevated fear-avoidance beliefs are a precursor to chronic disability from low back pain. However, the effectiveness of physical therapy intervention based on a fear-avoidance model is unknown. Methods. Sixty-six consecutive patients referred to physical therapy with low back pain of less than 8 weeks' duration were randomly assigned to receive fear-avoidance-based physical therapy (n = 34) or standard care physical therapy (n = 32). The intervention period lasted 4 weeks for this study. Disability, pain intensity, and fear-avoidance beliefs measures were recorded before and after treatment. A 6-month follow-up of the same measures was obtained by mail. Results. An intention-to-treat principle (last value forward) was used for data analyses that tested the primary and secondary hypotheses. The prediction of disability at 4 weeks and 6 months after treatment was significantly improved by considering the interaction between the type of treatment and the initial level of fear-avoidance beliefs. Both groups had significant within group improvements for disability and pain intensity. The fear-avoidance treatment group had a significant improvement in fear-avoidance beliefs, and fear-avoidance beliefs about physical activity were significantly lower than the standard care group at 4 weeks and 6 months after treatment. Conclusion. Patients with elevated fear-avoidance beliefs appeared to have less disability from fear-avoidance-based physical therapy when compared to those receiving standard care physical therapy. Patients with lower fear-avoidance beliefs appeared to have more disability from fear-avoidance-based physical therapy, when compared to those receiving standard care physical therapy. In addition, physical therapy supplemented with fear-avoidance-based principles contributed to a positive shift in fear-avoidance beliefs.
In an attempt to prevent acute low-back pain from becoming a chronic disability problem, an earlier study developed a statistical algorithm which accurately identified those acute low-back pain patients who were at high risk for developing such chronicity. The major goal of the present study was to evaluate the clinical effectiveness of employing an early intervention program with these high-risk patients in order to prevent the development of chronic disability at a 1-year follow-up. Approximately 700 acute low-back pain patients were screened for their high-risk versus low-risk status. On the basis of this screening, high-risk patients were then randomly assigned to one of two groups: a functional restoration early intervention group (n = 22), or a nonintervention group (n = 48). A group of low-risk subjects (n = 54) who did not receive any early intervention was also evaluated. All these subjects were prospectively tracked at 3-month intervals starting from the date of their initial evaluation, culminating in a 12-month follow-up. During these follow-up evaluations, pain disability and socioeconomic outcomes (such as return-to-work and healthcare utilization) were assessed. Results clearly indicated that the high-risk subjects who received early intervention displayed statistically significant fewer indices of chronic pain disability on a wide range of work, healthcare utilization, medication use, and self-report pain variables, relative to the high-risk subjects who do not receive such early intervention. In addition, the high-risk nonintervention group displayed significantly more symptoms of chronic pain disability on these variables relative to the initially low-risk subjects. Cost-comparison savings data were also evaluated. These data revealed that there were greater cost savings associated with the early intervention group versus the no early intervention group. The overall results of this study clearly demonstrate the treatment- and cost-effectiveness of an early intervention program for acute low-back pain patients.
STUDY DESIGN: Descriptive prognostic study.
OBJECTIVES: To identify outcome determinants of subacute low back pain.
SUMMARY OF BACKGROUND DATA: The factors predicting recovery from prolonged back pain among working adults are largely unknown.
MATERIALS AND METHODS: One hundred sixty-four employed patients with subacute (duration of pain 4-12 weeks) daily low back pain were recruited from primary health care to a randomized study. Data on potential predictive factors were collected before randomization. In multiple regressions using repeated measures analysis, the treatment received was adjusted when determining the impact of the predictive factors. Dependent outcome variables used were pain, perceived functional disability, generic health-related quality of life, satisfaction with care, days on sick leave, use of health care, and costs of health care consumption measured, at 3-, 6-, and 12-month follow-ups.
RESULTS: Age and intensity of pain at baseline predicted most of the outcomes. The perceived risk of not recovering was a stronger determinant of outcome than gender, education, or self-rated health status (which did not have any predictive value) or body mass index, expectations of treatment effect, satisfaction with work, or the presence of radicular symptoms below the knee (only slight predictive value). The only factors predicting the duration of sick leave were the duration of sick leave at baseline and the type of occupation.
CONCLUSION: Age and intensity of pain are the strongest predictors of outcome. Accumulation of days on sick leave is predicted by the duration of sick leave at entry and the type of work, but not by pain, perceived disability, or satisfaction with work.
STUDY DESIGN: A single-blind randomized controlled trial of a leaflet developed for people with acute low back pain was compared with the usual general practitioner management of back pain.
OBJECTIVE: To test the effectiveness of a patient information leaflet on knowledge, attitude, behavior, and function.
SUMMARY OF BACKGROUND DATA: Despite the commonality of back pain in general practice, little evidence on the effectiveness of simple interventions such as leaflets and advice on self-management has been reported. On the basis of a five-stage needs analysis, a simple leaflet was developed that considered the views of patients and health professionals.
METHODS: For this study, 64 patients with acute back pain were assigned to the leaflet or control group. The participants were visited at home after 2 days, 2 weeks, then 3, 6, and 12 months, where they completed a range of self-report measures. Behavioral aspects were discretely recorded by a "blinded" researcher. Primary outcomes were knowledge, attitude, behavior, and function.
RESULTS: In all, 272 home visits were undertaken. The findings show that at 2 weeks, knowledge about sitting posture was greater in the leaflet group (P = 0.006), which transferred to a behavioral difference (sitting with lumbar lordosis support) when participants were unaware that they were being observed (P = 0.009). This difference remained significant at 3 months. Patients in the leaflet group also were better at maintaining a wide base of support when lifting a light object than the control subjects throughout all five assessments. There were no significant differences in the functional outcomes tested.
CONCLUSIONS: This trial demonstrates that written advice for patients can be a contributory factor in the initial general practitioner consultation because it may change aspects of knowledge and behavior. This has implications for the management of acute back pain, with potential health gain.
In an earlier study, Gatchel et al. (J Occup Rehabil 13:1–9, 2003) demonstrated that participants at high risk for developing chronic low back pain disability (CLBPD), who received a biopsychosocial early intervention treatment program, displayed significantly more symptom improvement, as well as cost savings, relative to participants receiving standard care. The purpose of the present study was to expand on these results by examining whether the addition of a work-transition component would further strengthen the effectiveness of this early intervention treatment.
METHODS:
Using an existing algorithm, participants were identified as being high-risk (HR) or low-risk (LR) for developing CLBPD. HR participants were then randomly assigned to one of three groups: early intervention (EI); early intervention with work transition (EI/WT); or standard care (SC). Participants provided information regarding pain, disability, work status, and psychosocial functioning at baseline, periodically during treatment, and again 1 year following completion of treatment.
RESULTS:
At 1-year followup, no significant differences were found between the EI and EI/WT groups in terms of occupational status, self-reports of pain and disability, coping ability or psychosocial functioning. However, significant differences in all these outcomes were found comparing these groups to standard care.
CONCLUSION:
The addition of a work transition component to an early intervention program for the treatment of ALBP did not significantly contribute to improved work outcomes. However, results further support the effectiveness of early intervention for high-risk ALBP patients. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
