Randomized controlled trial of postoperative exercise rehabilitation program after lumbar spine fusion: study protocol

Abstract Background Lumbar spine fusion (LSF) effectively decreases pain and disability in specific spinal disorders; however, the disability rate following surgery remains high. This, combined with the fact that in Western countries the number of LSF surgeries is increasing rapidly it is important to develop rehabilitation interventions that improve outcomes. Methods/design In the present RCT-study we aim to assess the effectiveness of a combined back-specific and aerobic exercise intervention for patients after LSF surgery. One hundred patients will be randomly allocated to a 12-month exercise intervention arm or a usual care arm. The exercise intervention will start three months after surgery and consist of six individual guidance sessions with a physiotherapist and a home-based exercise program. The primary outcome measures are low back pain, lower extremity pain, disability and quality of life. Secondary outcomes are back function and kinesiophobia. Exercise adherence will also be evaluated. The outcome measurements will be assessed at baseline (3 months postoperatively), at the end of the exercise intervention period (15 months postoperatively), and after a 1-year follow-up. Discussion The present RCT will evaluate the effectiveness of a long-term rehabilitation program after LSF. To our knowledge this will be the first study to evaluate a combination of strength training, control of the neutral lumbar spine position and aerobic training principles in rehabilitation after LSF. Trial registration ClinicalTrials.gov Identifier NCT00834015peerReviewe

Reoperation Rates Following Instrumented Lumbar Spine Fusion

Study Design. A prospective cohort study. Objective. This study evaluated the cumulative reoperation rate and indications for reoperation following instrumented lumbar spine fusion (LSF). Summary of Background Data. LSF reduces disability and improves health-related quality of life for patients with several spinal disorders. The rate of instrumented LSF has drastically increased over the last few decades. The increased incidence of LSF, however, has led to increased reoperation rates. Methods. The data are based on the prospective LSF database of Tampere University Hospital that includes all elective indications for LSF surgery. A total of 433 consecutive patients (64% women, mean age 62 years) who underwent LSF in Tampere University Hospital between 2008 and 2011 were evaluated and indications for reoperations were rechecked from patient records and radiographs. The most common diagnosis for the primary surgery was degenerative spondylolisthesis and the mean follow-up time was 3.9 years. The cumulative incidence of reoperations and the ‘‘time to event’’ survival rate was calculated by Kaplan-Meier analysis. Results. By the end of 2013, 81 patients had undergone at least one reoperation. The cumulative reoperation rate at 2 years was 12.5% (95% confidence interval: 95% CI: 9.7–16.0) and at 4 years was 19.3% (95% CI: 15.6–23.8). The most common pathology leading to reoperation was adjacent segment pathology with a cumulative reoperation rate of 8.7% (95% CI: 6.1–12.5) at 4 years. The corresponding rates for early and late instrumentation failure were 4.4% (95% CI: 2.7–7.0) and 2.9% (95% CI: 1.9–7.1), respectively, and for acute complications, 2.5% (95% CI: 1.4–4.5). Conclusion. Although previous studies reported that early results of spinal fusion are promising, one in five patients required reoperation within 4 years after surgery. Patients and surgeons should be aware of the reoperation rates when planning fusion surgery. Key words: adjacent segment, complications, instrumented lumbar spine fusion, pathology, reoperation. Level of Evidence: 4 Spine 2018;43:295–301peerReviewe

Quality of life and disability: can they be improved by active postoperative rehabilitation after spinal fusion surgery in patients with spondylolisthesis? A randomised controlled trial with 12-month follow-up

Purpose The aim of the study was to investigate the effectiveness of the postoperative 12-month exercise program compared to usual care on disability and health-related quality of life (HRQoL) in patients after lumbar spine fusion surgery (LSF). Methods Altogether, 98 patients with isthmic (31) or degenerative (67) spondylolisthesis were randomised to exercise therapy group (EG) (n = 48) or usual care group (UCG) (n = 50) 3 months after LSF. EG patients had home-based progressive strength and aerobic training program for 12 months. UCG patients received only oral and written instructions of exercises. Oswestry Disability Index (ODI) and HRQoL (RAND-36) were evaluated at the time of randomization, at the end of the intervention and 1 year after intervention. Results The mean ODI score decreased from 24 (12) to 18 (14) in the EG and from 18 (12) to 13 (11) in the UCG during intervention (between-groups p = 0.69). At 1-year follow-up, 25 % of the EG and 28 % of the UCG had an ODI score ≥20. No between-group differences in HRQoL change were found at any time point. The mean (95 % CI) physical functioning dimension of the HRQoL improved by 10.0 (4.6–15.3) in the EG and by 7.8 (2.5–13.0) in the UCG. In addition, the role physical score improved by 20.0 (7.7–32.3) in the EG and by 16.4 (4.4–28.4) in the UCG during the intervention. Conclusions The exercise intervention did not have an impact on disability or HRQoL beyond the improvement achieved by usual care. However, disability remained at least moderate in considerable proportion of patients.peerReviewe