Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control.

BACKGROUND: We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting. METHODS: Based on a survey (n = 2480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (Visual Analogue Scale VAS > 34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP ≥ 2 times, LBP ≥ 2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (Control, n = 50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (Rehab, n = 43); progressive exercises (Physio, n = 43) and self-care advice (Advice, n = 40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (Visual Analogue Scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the Control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function. RESULTS: Mean differences between the Rehab and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 24 to - 1] for pain intensity, and 0.06 [0.00 to 0.12] for QoL. Mean differences between the Physio and Control groups were - 3 [95% CI -5 to - 1] for PHI, - 13 [- 29 to 2] for pain intensity, and 0.07 [0.01 to 0.13] for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence. CONCLUSIONS: Rehab and Physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the Advice and Control group results. No effectiveness on sickness absence was observed. TRIAL REGISTRATION: Number NCT00908102 Clinicaltrials.gov.

Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting.

BACKGROUND: Evidence shows that low back specific patient information is effective in sub-acute low back pain (LBP), but effectiveness and cost-effectiveness (CE) of information in early phase symptoms is not clear. We assessed effectiveness and CE of patient information in mild LBP in the occupational health (OH) setting in a quasi-experimental study. METHODS: A cohort of employees (N = 312, aged <57) with non-specific, mild LBP (Visual Analogue Scale between 10-34 mm) was selected from the respondents of an employee survey (N = 2480; response rate 71 %). A random sample, representing the natural course of LBP (NC, N = 83; no intervention), was extracted as a control group. Remaining employees were invited (181 included, 47 declined, one excluded) into a randomised controlled study with two 1:1 allocated parallel intervention arms ("Booklet", N = 92; "Combined", N = 89). All participants received the "Back Book" patient information booklet and the Combined also an individual verbal review of the booklet. Physical impairment (PHI), LBP, health care (HC) utilisation, and all-cause sickness absence (SA) were assessed at two years. CE of the interventions on SA days was analysed by using direct HC costs in one year, two years from baseline. Multiple imputation was used for missing values. RESULTS: Compared to NC, the Booklet reduced HC costs by 196€ and SA by 3.5 days per year. In 81 % of the bootstrapped cases the Booklet was both cost saving and effective on SA. Compared to NC, in the Combined arm, the figures were 107€, 0.4 days, and 54 %, respectively. PHI decreased in both interventions. CONCLUSIONS: Booklet information alone was cost-effective in comparison to natural course of mild LBP. Combined information reduced HC costs. Both interventions reduced physical impairment. Mere booklet information is beneficial for employees who report mild LBP in the OH setting, and is also cost saving for the health care system. TRIAL REGISTRATION: ClinicalTrials.gov NCT00908102.

The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting.

OBJECTIVE: Evaluate the effectiveness of two active interventions, aimed at secondary prevention of low back pain (LBP), in occupational health. METHODS: We performed a survey of LBP (n=2480; response rate 71%) and randomized 143 employees (66% males, 45 years) with LBP over 34 mm on VAS into Rehabilitation (n=43), Exercise (n=43) or self-care (n=40) groups. Primary outcomes were LBP, physical impairment (PI) and health-related quality of life (HRQoL) for two years and sickness absence (SA) days during four years (LBP specific, total). RESULTS: Compared to self-care, exercise reduced LBP at 12 months (mean difference (MD) -12 mm; 95% CI -21 to -2) and improved HRQoL at 12 and 24 months (0.03; 0.00 to 0.05), but did not reduce PI. The MDs of SA days in four years were -17 (-70 to 35, total) and -15 (-47 to 13, LBP specific). Exercise reduced the probability of LBP specific SA during the third and fourth year. Compared to self-care, Rehabilitation reduced LBP at 3 months (-10 mm; -19 to -1) and 6 months (-10 mm; -20 to - 1), but was not effective in HRQoL or PI. The MDs of SA days in four years were -41 (-93 to 8; total) and 5 (-30 to 47; LBP specific). Rehabilitation reduced the probability of total SA during first and second year and amount of total SA days in the fourth year. CONCLUSIONS: Among employees with relatively mild LBP, both interventions reduced pain, but the effects on SA and PI were minor. Exercise improved HRQoL. The effect sizes were rather small. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT00908102.

Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study.

BACKGROUND AND METHODS: The efficacy and safety of etoricoxib 60 mg/day in patients with established chronic low back pain (CLBP) were compared with those of diclofenac 150 mg/day in a 4-week, multicentre, randomized, double-blind, parallel-group trial. Four hundred and forty-six adult patients with CLBP (Quebec Task Force on Spinal Disorders Class 1 or 2) and with worsening pain upon discontinuation of pre-study analgesic medication were enrolled in the study. The study primary efficacy endpoint was change from baseline in Low Back Pain Intensity Scale (LBP-IS) score over the 4-week treatment period. Secondary and other efficacy endpoints included: changes in Roland and Morris Disability Questionnaire (RMDQ), Patient Global Assessment of Response to Therapy (PGART) and Low Back Pain Bothersomeness Scale (LBP-BS) scores. Early efficacy was assessed using PGART and LBP-IS scores 4 h after the first dose on the mornings of Days 1, 2 and 3. The overall safety and tolerability of etoricoxib 60 mg/day during 4 weeks of treatment were also assessed. RESULTS: The least-squares mean time-weighted change from baseline LBP-IS score over 4 weeks was -32.94 mm (95% CI -36.25, -29.63) for etoricoxib, indicating substantial efficacy in relief of pain. The treatment difference for the primary outcome was 2.51 mm (95% CI -1.50, 6.51), fulfilling the prespecified equivalence criterion of 95% confidence interval wholly within +/- 10 mm. Etoricoxib improved all secondary and other efficacy outcomes. There were no statistically significant between-group differences in the proportion of patients with one or more clinical adverse events (AEs) (etoricoxib 35%, diclofenac 39%), or the proportion of patients who discontinued due to AEs (etoricoxib 7%, diclofenac 5%). CONCLUSIONS: The results of this study confirm that, for adult patients with CLBP, etoricoxib 60 mg once daily over 4 weeks is effective for relief of pain and improvement of physical function and comparable to high-dose diclofenac 150 mg daily.

Medication calculation skills of graduating nursing students in Finland.

The aim of this study was to describe the basic mathematical proficiency and the medication calculation skills of graduating nursing students in Finland. A further concern was with how students experienced the teaching of medication calculation. We wanted to find out whether these experiences were associated with various background factors and the students' medication calculation skills. In spring 1997 the population of graduating nursing students in Finland numbered around 1280; the figure for the whole year was 2640. A convenience sample of 204 students completed a questionnaire specially developed for this study. The instrument included structured questions, statements and a medication calculation test. The response rate was 88%. Data analysis was based on descriptive statistics. The students found it hard to learn mathematics and medication calculation skills. Those who evaluated their mathematical and medication calculation skills as sufficient successfully solved the problems included in the questionnaire. It was felt that the introductory course on medication calculation was uninteresting and poorly organised. Overall the students' mathematical skills were inadequate. One-fifth of the students failed to pass the medication calculation test. A positive correlation was shown between the student's grade in mathematics (Sixth Form College) and her skills in medication calculation.

Perioperative documentation in Finland.

In Finland, research studies about perioperative documentation are few, and there are no professional recommendations for perioperative documentation, such as AORN s Standards, Recommended Practices, and Guidelines. Exploring current documentation practices and contents used in Finland is the first step to establishing a standard for perioperative documentation. The need for this type of exploration resulted in a study that found that the aim of nursing documentation is not always clear, and current documentation practice does not necessarily reveal the decision making that directs patient care, demonstrate nursing resources needed, or provide data for evaluating and developing perioperative practice. Education, motivation, and computerization generally were mentioned as a means to develop documentation.

Comparison of trunk strength measurements between two different isokinetic devices used at clinical settings.

Intradevice reliability of isokinetic trunk strength measurements has been studied frequently, but no evidence is available on interdevice reliability. This motivated the present study, in which two isokinetic devices, the Ariel 5000 and Lido Multi-Joint II, were compared in a sample of 41 subjects (20 healthy and 21 low back pain subjects). The measurements were made in a random order with both machines. The results showed that the two isokinetic machines gave quite different results in trunk flexion-extension strength measurements. A statistically significant difference was present in the average peak torques between the two devices, with the exception of flexion at low angular velocity (60 degrees/s), and the correlations between the two measurements were low. The results were assumed to be more of a reflection of the interdevice variations (hardware and software, attachment of the subject) than of learning effects or other phenomena. We conclude that isokinetic trunk-muscle strength test results with the Ariel and Lido are device specific, and one cannot automatically compare results obtained from different devices with each other.

Low synthesis rate of type I procollagen is normalized during active back rehabilitation.

STUDY DESIGN: Open, prospective trial with patients participating in an active back restoration program. OBJECTIVES: To compare the concentrations of biochemical indicators of Type I and III collagen synthesis and Type I collagen degradation in the serum of patients with chronic low back pain and healthy control subjects and to evaluate the effect of active back rehabilitation based on vigorous exercise on collagen metabolism. SUMMARY OF BACKGROUND DATA: The aim of active back rehabilitation is to restore the physical function of low back pain patients falling into the so-called "deconditioning syndrome." The changes in functional muscle strength measurements during the restoration rehabilitation program always depend on motivation, learning phenomena, and fear of pain and injury, so that even more objective ways of showing changes in physical activity are needed. METHODS: Specific radioimmunoassays for the amino-terminal (PINP) and carboxy-terminal (PICP) propeptides of Type I procollagen, the amino-terminal propeptide of Type III procollagen (PIIINP), and the cross-linked carboxy-terminal telopeptide of Type I collagen (ICTP) were used for serum samples obtained from 41 patients before, during, and after an active back restoration program and from 16 age- and sex-matched healthy control subjects. RESULTS: The circulating concentrations of PINP and PICP were initially lower in the patients ([mean +/- SD] 35.3 +/- 12.5 micrograms/L and 119.0 +/- 32.6 micrograms/L, respectively) than in the control subjects (47.9 +/- 18.0 micrograms/L and 136.7 +/- 47.7 micrograms/L, respectively; P < 0.05 for PINP). Toward the end of the active back rehabilitation program, both PINP and PICP increased in the patients (P < 0.001 for the increase between the initial level and the end of rehabilitation). There was a significant difference in the time courses of these changes, with the circulating PICP concentration increasing earlier than that of PINP. In the intervention group, the PIIINP concentration also increased (P < 0.01), whereas the ICTP concentration remained unchanged, with a tendency to decrease. No changes occurred in the control subjects. CONCLUSIONS: Active back rehabilitation based on vigorous exercise increases. Type I collagen synthesis in patients with chronic low back pain; this may provide a means of objectively verifying the effects of such rehabilitation.

Height changes among chronic low back pain patients during intense physical exercise.

The possible effects of intense physical exercise on the total body stature of low back pain patients were monitored by circadian total body height measurements. The height was measured with a statiometer, and the change in height was correlated with the changes in the range of motion, pain and subjective disability and degree of disc degeneration seen on magnetic resonance imaging (MRI) pictures. The stature of 24 low back pain patients was measured during a 3-week period. There was an increase of about 3 mm in height after only 4 days of exercise, and by the end of the programme the morning height increased on average by 7.2 mm. There were also 12 non-rehabilitated low back pain patients but no such increase was noted among them. The gain of height and reduction of pain were found to be statistically significantly correlated (P = 0.0001, r = -0.41), as did the gain of height and the decrease of back disability (Oswestry index) (P < 0.0001, r = -0.39). Circadian total height measures but not the MR images will change due to the active back rehabilitation programme.

Isokinetic performance capacity of trunk muscles. Part II: Coefficient of variation in isokinetic measurement in maximal effort and in submaximal effort.

It has been claimed that with the aid of isokinetic trunk strength measuring devices it is possible to distinguish true muscular weakness from submaximal effort in the test. This proposition is based on the presumption that in the isokinetic trunk strength test identical performances can only be reproduced by maximal effort. The purpose of this study was to investigate whether it is possible to distinguish maximal effort from submaximal with the aid of the coefficient of variation (CV) in an isokinetic trunk muscle strength test. The study group included 35 (21 male and 14 female) subjects of whom 12 were healthy, 10 had a mild low-back pain and 13 had a more severe chronic low-back pain. The subjects performed five consecutive bendings both with maximal (100%) and submaximal (50%) efforts at a speed of 90 degrees/second. In maximal effort only healthy subjects reached an average level of CV close to 10% both in extension and in flexion. In the chronic low-back pain group the average CV was close to 20%. The difference in CV was statistically significant (p < 0.05-0.02) between the healthy and the chronic low-back pain subjects. In the submaximal effort all health groups had a CV of approximately 20% or more and no significant differences were found. The group of slightly variable measurements (CV = 11-20%) was remarkably large in both the maximal and submaximal effort. The results suggest that an effort with a CV of 11-20% cannot be classified as definitely submaximal or maximal. When the CV is less than 10% the effort can be fairly certainly classified as maximal.

Isokinetic performance capacity of trunk muscles. Part I: The effect of repetition on measurement of isokinetic performance capacity of trunk muscles among healthy controls and two different groups of low-back pain patients.

The aim of this investigation was to assess the reproducibility of the isokinetic trunk muscle performance measurement among patients with different degrees of low-back pain. Twenty-two healthy volunteers, 20 patients with mild and 18 patients with severe low-back pain participated in isokinetic measurements. Lidoback isokinetic dynamometer was used. The measurements were performed with the subjects standing, using velocities of 60, 90 and 120 degrees/second. Five repetitions were performed at each velocity. All subjects were tested three times with a 1-week interval between the tests. Peak torque, average peak torque, coefficient of variation, total work done and peak torque to body weight ratio were calculated for each velocity for both flexion and extension. The results showed that in every measurement peak torque, average peak torque, peak torque to body weight ratio and total work done correlated with each other very strongly both in flexion and extension (r > or = 0.9). The average peak torques increased in further measurements. The change had a strong correlation with the severity of the back problem, which was evaluated by means of the Oswestry disability index. The critical value was found to be 20% in the Oswestry index: values above this meant big changes between measurements and values below this meant small changes between measurements.

Spinal shrinkage due to +Gz forces.

BACKGROUND: Fighter pilots frequently complain of inflight pain in the cervical or lumbar spine. As to the cervical spine, there is evidence that repeated exposures to high +Gz forces and inflight neck pain may cause premature cervical disk degeneration. Whether inflight lumbar pain caused by high +Gz forces has a similar effect on the lumbar spine has not been studied. HYPOTHESIS: The aim of the study was to investigate whether high +Gz forces during aerial combat maneuvering reduces the body height. Investigation to determine whether any long-term degenerative changes occur in the lumbar spine was beyond the scope of this study. METHODS: The body height of 20 junior fighter pilots was measured before and after 30 min of recumbent rest and after high-G flights. A special measuring device was used. Measurements were also made with the pilots sitting fully equipped in a fighter aircraft on the ground. RESULTS: Maneuvering under high +Gz forces for 40 min caused a 4.9 mm decrease in body height. Recumbent rest before flights increased body height by 2.5-3.5 mm, and sitting in an aircraft returned body height to the values measured before rest. CONCLUSIONS: The findings indicate that +Gz forces place a high stress on the spinal column. Therefore, the work of a fighter pilot can be considered to be physically demanding with respect to the spinal column.

Relationship of the Pain Disability Index (PDI) and the Oswestry Disability Questionnaire (ODQ) with three dynamic physical tests in a group of patients with chronic low-back and leg pain.

OBJECTIVE: To determine the relationship between overall disability in daily activities, assessed with the Pain Disability Index (PDI) and the Oswestry Disability Questionnaire (ODQ), and impaired performance on three physical tests in patients with chronic low-back pain. DESIGN AND SUBJECTS: The PDI and ODQ were administered in a cross-sectional study, before beginning a back rehabilitation program, to 45 patients with low-back pain of > or = 3 months' duration, with or without radiation to the legs. All patients also performed repetitive sit-up, arch-up, and squatting tests. SETTING: Tertiary care center. RESULTS: Modestly significant (p < 0.05) or significant (p < 0.01) inverse correlations (Pearson's r = 0.30-0.41) were noted between the PDI and the ODQ and all three physical performance tests. When normative data were used, the correlation (Spearman's rs = -0.45) between PDI and the squatting test remained significant (p < 0.01), whereas it was modestly significant (rs = -0.33, p < 0.05) between the ODQ and squatting test and between the PDI and arch-up test (rs = -0.35, p < 0.05). Compared with patients presently working, those on sick leave had significantly higher scores on the PDI and ODQ (Wilcoxon's two-sample test: p < 0.001) and also significantly worse performance on all physical tests (p < 0.001). CONCLUSIONS: The PDI and ODQ, as measures of self-perceived disability, and impaired performance on repetitive squatting, arch-up, and sit-up tests, as measures of physical capability, show some overlap in low-back-pain patients. Both types of disability measures are clearly influenced by the patient's work status.

Intercorrelation and test-retest reliability of the Pain Disability Index (PDI) and the Oswestry Disability Questionnaire (ODQ) and their correlation with pain intensity in low back pain patients.

OBJECTIVE: To determine the intercorrelation between subjective disability, as assessed with the Pain Disability Index (PDI) and the Oswestry Disability Questionnaire (ODQ) and their correlation with visual analogue scale (VAS) pain intensity ratings. DESIGN AND SUBJECTS: Questionnaires were administered to 94 patients with chronic low back pain with or without radiation into the legs of at least 3 months' duration. SETTING: Tertiary care center. RESULTS: High correlations were noted between the ODQ and PDI (r = 0.83) and PDI factor 1 (r = 0.84), a subscale of the PDI. Lower correlations were noted between pain intensity (VAS) scores and the ODQ (r = 0.62) and the PDI (r = 0.69). A weaker correlation (r = 0.41) was noted between the ODQ and PDI factor 2. Intraclass correlation coefficients (ICC) for test-retest reliability in 20 patients (time interval 1 week) were for the ODQ ICC = 0.83, PDI ICC = 0.91, PDI percentage score ICC = 0.91, PDI factor 1 ICC = 0.87, and PDI factor 2 ICC = 0.73, respectively. CONCLUSIONS: The present results suggest that either the PDI or the percentage score PDI and also the even shorter-to-administer PDI factor 1 may be useful and reliable tests for the assessment of subjective disability in low back pain patients. As noted by the moderate intercorrelations with pain intensity scores, both the PDI and the ODQ address a broader concept of disability than that directly related to pain intensity.

Outcome of a multimodal treatment including intensive physical training of patients with chronic low back pain.

A comprehensive 4-week inpatient treatment including intensive physical training was evaluated in 194 chronic low back pain patients of whom 101 were working and 79 were on sick leave. Physical performance was assessed by measurements of spinal mobility, isometric trunk flexion and extension strength, and isokinetic lifting strength. Outcome was evaluated by a functional capacity index and work status changes reported at a 12-month follow-up. There was a 30-50% average increase in physical performance during treatment. At the 12-month follow-up the functional capacity index showed an average increase from 35.4 to 39.3 points (score range 24-48). At follow-up 28% of the sicklisted patients had returned to work and of those employed before treatment 14% were on sick leave. Associations between outcome and the improvement in physical measurements and their level at discharge were determined by stepwise multiple and logistic regression analyses. Among the physical measurements only increase in spinal mobility was associated with functional capacity index in women and return to work in both men and women at the 12-month follow-up. The overall results showed that intensive physical training and improved physical performance did not play crucial roles in the rehabilitation of chronic low back pain patients, at least when return to work was used as the outcome criterion.

Outcome of two multimodal back treatment programs with and without intensive physical training.

We compared the results of two multimodal back treatment programs (program A: n = 134; program B: n = 175) using pain, functional capacity, sickness absence, subjective state of health, depression, and work status as outcome variables. Whereas in program A exercise was guided by pain, in program B a "no pain, no gain" rationale was used as a basis for intensive physical training. Neither of the programs included direct attempts to influence the patient's environment (i.e., to find employment or to modify working conditions). In both programs, a clear decrease in pain and an increase in functional capacity was found from the pretreatment phase to the 12-month follow-up. These changes were, however, stronger in program B. Days of absence decreased significantly in group B, but the change was not significantly different from that in group A. On the whole, the more intensive training showed somewhat better results, even though the difference was not substantial. In contrast to some earlier results, there was no statistically significant increase in the proportion of those employed after treatment in either group. The results indicate that intensive physical exercise does not, as such, solve the problem of back disability in a country that has a highly developed social security system. More active interventions in work and work-life are needed.

Effects and follow-up of a multimodal treatment program including intensive physical training for low back pain patients.

The results of a comprehensive 4-week treatment program including intensive physical training were evaluated in 65 chronic low back pain patients. Marked increases in measures of spinal mobility, trunk muscle strength and lifting capacity were found during the treatment, but no average increase in pain ratings. At 3-week and 12-month follow-ups a statistically significant decrease in subjective disability and pain was found, but the percentage of patients who were working was unchanged. This points to a need for more work-oriented rehabilitation efforts in the treatment.