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Open Access Highly Accessed Study protocol

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

Sami Tarnanen1*, Marko H Neva2, Joost Dekker3, Keijo Häkkinen4, Kimmo Vihtonen2, Liisa Pekkanen5 and Arja Häkkinen16

Author Affiliations

1 Department of Health Sciences, University of Jyväskylä, Jyväskylä, Finland

2 Department of Orthopaedic and Trauma Surgery, Tampere University Hospital, Tampere, Finland

3 Department of Rehabilitation Medicine, VU University Medical Center, Amsterdam, The Netherlands

4 Department of Biology of Physical activity, University of Jyväskylä, Jyväskylä, Finland

5 Department of Orthopaedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland

6 Department of Physical Medicine and Rehabilitation, Central Finland Central Hospital, Jyväskylä, Finland

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BMC Musculoskeletal Disorders 2012, 13:123  doi:10.1186/1471-2474-13-123

Published: 20 July 2012

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 NCT00834015

Keywords:
Lumbar fusion; Disability; Pain; Quality of life; Spine; Exercise; Rehabilitation