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.
RCT Entities:
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.
Authors: Frederieke G Schaafsma; Karyn Whelan; Allard J van der Beek; Ludeke C van der Es-Lambeek; Anneli Ojajärvi; Jos H Verbeek Journal: Cochrane Database Syst Rev Date: 2013-08-30
Authors: J Bart Staal; Hynek Hlobil; Maurits W van Tulder; Albère J A Köke; Tjabe Smid; Willem van Mechelen Journal: Sports Med Date: 2002 Impact factor: 11.136
Authors: Paul Baker; Carol Coole; Avril Drummond; Sayeed Khan; Catriona McDaid; Catherine Hewitt; Lucksy Kottam; Sarah Ronaldson; Elizabeth Coleman; David A McDonald; Fiona Nouri; Melanie Narayanasamy; Iain McNamara; Judith Fitch; Louise Thomson; Gerry Richardson; Amar Rangan Journal: Health Technol Assess Date: 2020-09 Impact factor: 4.014