Functional restoration versus outpatient physical training in chronic low back pain: a randomized comparative study.

STUDY DESIGN: A randomized parallel-group comparative trial with a 1-year follow-up period was performed. OBJECTIVE: To compare the effect of a comprehensive functional restoration program involving intensive physical training, ergonomic training, and behavioral support (39 hours per week for 3 weeks) with the effect of outpatient intensive physical training (1.5 hours three times per week for 8 weeks). SUMMARY OF BACKGROUND DATA: Nonrandomized studies conducted in the United States favor functional restoration for patients with chronic low back pain. Two previously reported randomized studies from the authors' Back Center in Copenhagen concur with this recommendation, although the positive effects in one of the studies had faded out after 2 years. Randomized functional restoration studies in Canada and Finland have failed to demonstrate any substantive effect. METHODS: Initially, 138 patients with chronic low back pain were included in the current study. They then were randomized to either functional restoration (n = 64) or outpatient intensive physical training (n = 74). Of the initial 138 patients, 11 never started (5 and 6, respectively); 21 dropped out during treatment (8 and 13); and 7 of the graduates did not take part in the 1-year follow-up evaluation (3 and 4). The conclusions were drawn from the 99 patients (48 and 51, respectively) who graduated and participated in a 1-year follow-up evaluation. The median age of the patients was 42 years (range, 21-55 years) The female-to-male ratio was 68 to 31, and the median sick leave days during the preceding 3 years was 180 (range, 0-1080 days). The average back pain was rated 5.5 on a scale of 0 (no pain) to 10 (maximal pain). For these variables, there were no important differences between the groups. However, the functional restoration group tended to be more capable of work at baseline (58% vs 42%; P = 0.09). RESULTS: At the 1-year follow-up evaluation, overall assessment favored functional restoration. Otherwise, no significant differences were observed regarding work capability, sick leave for those at work, health care contacts,back pain, leg pain, or self-reported activities of daily living. CONCLUSIONS: Only in terms of overall assessment, the functional restoration program was superior to a comparatively short time-consuming outpatient physical training program. DISCUSSION: It may be that lower economic benefits during sick leave in the United States lead to favorable results from functional restoration programs, whereas greater benefits in Canada, Finland, and Denmark result in different conclusions. Finally, it may be that the difference in results across studies points simply to whether the studies were randomized.

[Predictive factors of the effect of multidisciplinary, intensive rehabilitation of back pain. Demographic, socioeconomic and physical factors]. / Praediktive faktorer for effekt ved tvaerfaglig, intensiv rygrehabilitering. Demografiske, socioøkonomiske og fysiske faktorer.

In order to identify possible predictive factors for success from rehabilitation in a functional restoration (FR) program for patients with chronic low back pain, pre-treatment baseline variables were correlated to different outcome parameters following treatment in either a FR program or control programs. A prospective clinical trial involving 816 patients was carried out. Of the total cohort 621 patients participated in a FR program and 195 in control groups. The results showed that different factors could be identified as useful in predicting outcome from a FR program, but most of these factors were also shown to predict success for controls of shorter outpatient programs or of no treatment.

Can it be predicted which patients with chronic low back pain should be offered tertiary rehabilitation in a functional restoration program? A search for demographic, socioeconomic, and physical predictors.

STUDY DESIGN: A prospective clinical trial was conducted that involved six groups of patients with chronic low back pain selected from a large cohort (N = 816). OBJECTIVES: To correlate pretreatment baseline variables with outcome parameters after treatment in a functional restoration program or in control programs, to identify possible factors predictive of the need for functional restoration. SUMMARY OF BACKGROUND DATA: Since the functional restoration program was first described, research has focused on identifying patients who will or will not benefit from such a program. The value of previous studies is limited, however, because predictive factors from a control group were not "subtracted." METHODS: Eight hundred sixteen patients with chronic low back disability were included. All had a structured medical examination, including various physical tests before participation in either a functional restoration program (n = 621) or shorter "control" outpatient programs (n = 144). A smaller group of the cohort (n = 51) had no treatment and served as a pure control group. Six groups were selected from the cohort: Three underwent an identical functional restoration program and three underwent different outpatient control programs. Several baseline demographic, physical, and socioeconomic variables were correlated to 1-year outcome parameters. RESULTS: Age, days of sick leave, connection to the work force, and back pain intensity, were significantly correlated to success 1 year after entry into the study in all groups, no matter what kind of treatment was administered. Back muscle endurance, sports activity, activity of daily living scores, and vibrations were of importance in some outcome parameters for success after functional restoration. Smoking was positively correlated to disability pension. Days of sick leave and, in functional restoration, ability to work were the only factors that were correlative with statistics for people who withdrew. CONCLUSIONS: Different factors can be identified as predictive of outcome in a functional restoration program, but most of these factors were also shown to predict success for shorter control outpatient programs or of no treatment.

A prospective, randomized 5-year follow-up study of functional restoration in chronic low back pain patients.

A functional restoration (FR) program, dealing with a combination of intensive physical and ergonomic training, psychological pain management, and patient education, was tested in two randomized, parallel group studies. In one of these patients following the FR program were compared with a non-treated control group (project A), and in the other with patients on two less intensive treatment programs (project B). A total of 238 chronic low back pain patients participated in the two studies, 106 entering project A and 132 project B. Patients from the two projects were comparable except that the patients in project A were recruited from all over the country, whereas patients in project B all were living in and around Copenhagen. Thirteen patients never started any treatment, and 20 patients (9%) dropped out during the treatment period. Of the 207 who completed treatment, 89% returned a mailed questionnaire 5 years later. This was the case for 55% of the drop-outs. The questions referred to work situation, pain level, activities of daily living, days of sick leave, contact with health care professionals, physical activity, use of medication, and a subjective overall assessment. The results show that in project A the treated group reported significantly fewer contacts with the health care system and significantly fewer days of sick leave over the 5-year follow-up period compared to the control group. In all other parameters, including work ability, there was no statistically significant difference between the two groups. In project B, patients treated in the FR program did significantly better in most measured parameters, except in leg pain, use of pain medication and sport activity, where no significant differences were found between groups. The overall result shows a positive long-term effect of the FR program, but it also shows the necessity of testing a given treatment in different projects and designs, among other things due to statistical variations.

Functional restoration for chronic low back pain. Two-year follow-up of two randomized clinical trials.

STUDY DESIGN: Two randomized, prospective clinical trials involving 238 chronic low back disability patients were carried out. Results at 2-year follow-up are presented. OBJECTIVES: To compare the clinical outcomes of a multidisciplinary functional restoration program with a nontreated control group (Project A) and with two less intensive but different training programs (Project B). SUMMARY OF BACKGROUND DATA: The effectiveness of functional restoration programs has not been firmly established. Results from trials carried out in the United States differ from those in trials conducted in other countries. Only a few of these studies have been carried out as prospective and randomized clinical studies. METHODS: Two hundred thirty-eight patients with chronic low back disability of at least 6 months' duration were included. There were 106 patients in project A and 132 patients in project B. Two years after completion of treatment patients were mailed a questionnaire that included questions regarding their work status, pain and disability levels, number of sick leave days, number of medical care contacts, medication use, physical activity levels, and subjective overall assessment of their "back life situation." RESULTS: Patients in both studies were comparable at inclusion, except that patients in Project A were recruited from all of Denmark, whereas those in Project B were from the greater Copenhagen area. Thirteen patients did not report for treatment after randomization. Of the remaining 225 patients, 20 (9%) did not complete treatment. The questionnaire response rate was 94%. In Project A, those patients receiving treatment (functional restoration) reported significantly less contact with the health care system, fewer sick leave days, and a less disabled life style during the follow-up period, compared with reports of patients in the control group. Other effect parameters did not demonstrate a significant difference between the two groups. In Project B, all effect parameters reported, except leg pain and medication usage, were significantly in favor of functional restoration, compared with reports from the less intensively treated groups. CONCLUSIONS: The functional restoration program seems effective in various parameters compared with the less intensive programs, but the differences in outcome in the two parallel studies indicate the necessity of testing a treatment program in different settings, in that the statistical variation may be a major factor in results of different studies.

Comparison of three intensive programs for chronic low back pain patients: a prospective, randomized, observer-blinded study with one-year follow-up.

In a randomized, blinded study, we compared the outcome from a full-time functional restoration program with the outcome from shorter active rehabilitation programs for patients with chronic, disabling low back pain. The study initially included 132 patients, randomized into one of three treatment programs: (1) an intensive 3-week multidisciplinary program; (2) active physical training and back school; or (3) psychological pain management and active physical training. Nine of the randomized patients never started in any program, so the studied population consisted of 123 patients. Of these, 14 patients (11%) dropped out. The results presented here are at 1 year following treatment, where we achieved a 92% response rate, including the drop-outs. The functional restoration program was superior to the shorter programs as to work-ready rate, health care contacts, back pain level, disability level, staying physically active, and reduction in analgesics. There was no significant difference between Programs 2 and 3 in most of these parameters. As for sick leave and leg pain, there was no significant difference between Programs 1 and 2, although a difference was observed when comparing Program 3 with each of the other two. Conclusively, it seems that there is human, as well as economical, benefit from a functional restoration program compared to less intensive programs for these patients.

Functional restoration in chronic low back pain.

Conventional treatments have not slowed down the ever expanding low back pain (LBP) problem. Traditional treatment has most probably contributed to the growth of the problem. Therefore, in a search for new solutions, 'functional restoration' has been devised. In connection with chronic LBP the term has been associated with a full-day program lasting from 3 to 5 weeks. It includes multidisciplinary treatment of patients in groups with intensive physical and ergonomic training, psychological pain management, back school, as well as teaching in social/work related issues. The key concepts are 'acceptance of the pain', 'activity', 'self-responsibility', 'multidisciplinary' and 'quantitative functional evaluation (QFE)'. The latter is aimed so that the participants can feel the physical improvement, encouraging them to be able to go back to work, or at least to lead a more active life style. Several controlled studies suggest a lasting effect in terms of regaining their ability to work and improving pain behavior for a good part of disabled chronic LBP patients. However, it is noteworthy that randomized studies seemingly show poorer results than studies not employing randomized controls.

Multidisciplinary intensive treatment for chronic low back pain: a randomized, prospective study.

BACKGROUND: Americans with low back pain have been helped to return to work by multidisciplinary intensive treatment programs. Whether this treatment method will succeed in countries with a more generous social welfare system, where the incentive to return to work might be less, is not proven. OBJECTIVES: To evaluate a Danish program of functional restoration combined with behavioral support. METHODS: Patients who had experienced at least 6 months of disabling low back pain were randomly assigned to either a 3-week intensive treatment program (n = 55) or an untreated control group (n = 51). RESULTS: Of the 106 patients randomized, 94 (89%) returned for a 4-month follow-up visit. At that time, 29 (64%) of the 45 treated patients were able to work, compared with 14 of 49 (29%) in the control group. The treated patients had used fewer days of sick leave (P < .02), had contacted health care. professionals fewer times (P < .001), and had lower pain and disability scores. CONCLUSIONS: Although such programs are expensive, they can reduce pension expenditures, sick leave days, health care contacts, and pain.

Active treatment programs for patients with chronic low back pain: a prospective, randomized, observer-blinded study.

Several new studies have indicated that an active approach to patients with chronic disabling low back pain (LBP) seems effective. Some of these studies emphasize the importance of dealing with the patient's total situation in comprehensive multidisciplinary programs--the bio-psycho-social model. However, these programs are expensive. The aim of this study was to evaluate the rehabilitation outcome from three different active programs in terms of: (1) return-to-work rate, (2) days of sick leave, (3) health-care contacts, (4) pain and disability scores, and (5) staying physically active. The subjects included 132 patients randomized to the study, of whom 123 started one of the treatment programs. They had all had at least 6 months of chronic LBP. The patients were randomized into one of three programs: group 1--a full-time, intensive 3-week multidisciplinary program, including active physical and ergonomic training and psychological pain management, followed by 1 day weekly for the subsequent 3 weeks; group 2--active physical training, twice a week for 6 weeks, for a total of 24h; group 3--psychological pain management combined with active physical training, twice a week for 6 weeks, also for a total of 24h. The results presented here are based on data collected 4 months following treatment, which shows an 86% response rate. The initial examination and the follow-up evaluation were performed by a blinded observer. The results show that 4 months after treatment, the intensive multidisciplinary program is superior to the less intensive programs in terms of return-to-work rate, health-care contacts, pain and disability scores, and staying physically active.(ABSTRACT TRUNCATED AT 250 WORDS)

[Intensive multidisciplinary treatment of back pain--2 controlled prospective studies]. / Intensiv tvaerfaglig rygbehandling--to kontrollerede, prospektive undersøgelser.

The aim of this study was to evaluate an intensive, multidisciplinary functional restoration program for people with chronic low back pain. The program was compared to a non-treated control group in project A, and to less intensive treatment programs in project B. Both projects were randomized and observer blinded. Two hundred and thirty-eight patients were included, 106 entering project A and 132 project B. All had had chronic low back disability of at least six months duration, with an average of one year's sick leave due to low back pain over the last three years. Their average age was 41 years. The results at follow-up (conducted four months after treatment, follow-up rate 90% in project A and 86% in project B) showed that 67% of the treated patients in project A were able to work compared to 28% in the control group. In project B, 75% of the patients treated in the functional restoration program were able to work, the corresponding numbers from the less intensive programs being 48% and 40%. Numbers of days of sick leave, contacts to the health-care system and pain- and disability-scores were significantly lower for the patients treated in the functional restoration program compared to the other groups in both projects. Functional restoration is more expensive to carry out, but the long-term benefits in form of reductions in pensions, sick leave and contacts to the health-care system, not to mention reduced pain for the patients, seems to justify this expenditure.

[Why intensive rehabilitation of patients with chronic back problems?]. / Hvorfor intensiv rehabilitering af kroniske rygpatienter?

When patients with chronic back trouble are improved after intensive rehabilitation, in all likelihood it is due more to changes in pain behaviour than to physiological effects of treatment. The Copenhagen Spine Center at the Danish national hospital, Rigshospitalet has launched an eight hours a day, three-week programme of cardiovascular fitness, progressive weight training, stretching, ergonomics, psychology and an extended back school, with a view to modifying the self-image and pain behaviour of long term sick-certificated patients with back problems, in order to enable them to return to work.

Disability exaggeration as a predictor of functional restoration outcomes for patients with chronic low-back pain.

Many of the individual biological, psychological, and social factors attributed to low-back disability have been tested previously for their ability to predict treatment outcomes. To test the assumption that disability exaggeration affects treatment outcomes, models were developed to quantify this complex characteristic and to test its predictive value. Two hundred fifty-eight patients with chronic back disability entering a program of functional restoration were initially evaluated with a battery of tests, including measurements of trunk flexibility, lifting capacity, cycling endurance, self-assessments of pain and disability, and psychological attributes. On the basis of these measurements, patients were characterized as disability exaggerators if by peer comparison their self-assessments of pain and disability were in the most severe range despite high levels of physical capacity. Program completion and work status 1 and 2 years after treatment were compared between disability exaggerators and their peers. Individual initial attributes associated with program completion included pain intensity and Million Visual Analogue scores, lifting capacity, trunk flexibility, some Minnesota Multiphasic Personality Inventory and Million Behavioral Health Inventory scales, and cigarette smoking. One-year re-employment was associated with Minnesota Multiphasic Personality Inventory Scale 8, Wechsler Adult Intelligence Score-Revised, and cycling endurance. There were no significant associations between any individual factor and 2-year work status. Only two of the 12 disability exaggeration models distinguished between program graduates and dropouts, and none of the models accurately predicted return to work following treatment. Prescription of intensive multidisciplinary treatment should not be denied on the basis of any individual patient attribute or of disability exaggeration, as measured in this study.(ABSTRACT TRUNCATED AT 250 WORDS)

Posture, acceptability and energy consumption on a tiltable and a knee-support chair.

Sitting postures on a knee-support (Balans®) chair and a tiltable chair were investigated with 12 healthy subjects during office work and simulated assembly work. After at least 3 weeks' adaptation to each chair, the subjects were investigated for 1 hour on each chair in stratified sequence. Postures were evaluated by means of a statometric method. Spinal load was further estimated by measuring stature shrinkage over each sitting period. Energy consumption was roughly assessed by pulse measurements. Finally, subjective acceptability was rated by a 5-point scale. Posture effects of the Balans® chair, taken in relation to the tiltable chair, were primarily a forward tilt of the pelvis and a change toward lumbar lordosis. Secondly, the trunk was vertical compared to the slightly backward-inclined position in the tiltable chair. The head was most vertical in the Balans® chair. No effect on spinal shrinkage or pulse was observed. The subjective rating seemed to favour the tiltable chair if used over longer periods. However, the Balans(®) chair may be a good alternative for some seated periods and special tasks.

Geophysical variables and behavior: V. Human performance in ionized air.

An experiment was conducted to investigate the claim that human performance may be enhanced by exposure to artificially high concentrations of negative air ions. 16 subjects, only half of whom were informed of the ion level in each session, performed reasoning, psychomotor, and memory-search tasks. Despite adequate control of confounding variables, no clear evidence was obtained in support of the view that negative ions in the air influence performance.