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.