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Randomized Clinical Trial of Lumbar Instrumented Fusion and Cognitive Intervention and Exercises in Patients with Chronic Low Back Pain and Disc Degeneration

Ivar Brox, Jens MD, PhD*; Sørensen, Roger MD*; Friis, Astrid PT*; Nygaard, Øystein MD, PhD†; Indahl, Aage MD, PhD‡; Keller, Anne MD§; Ingebrigtsen, Tor MD, PhD∥; Eriksen, Hege R. PhD¶; Holm, Inger PT*; Koller, Anne Kathrine PT*; Riise, Rolf MD*; Reikerås, Olav MD*

doi: 10.1097/01.BRS.0000083234.62751.7A
Randomized Trial

Study Design. Single blind randomized study.

Objectives. To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.

Summary of Background Data. To the authors’ best knowledge, only one randomized study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician.

Patients and Methods. Sixty-four patients aged 25–60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4–L5 and/or L5–S1 at radiographic examination were randomized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The main outcome measure was the Oswestry Disability Index.

Results. At the 1-year follow-up visit, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (−6.7 to 11.4) (P = 0.33). Improvements inback pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment, and lower limb pain was reduced more after surgery. The success rateaccording to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%.

Conclusion. The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomized to cognitive intervention and exercises, or lumbar fusion.

From the *Department of Orthopedic Surgery, National Hospital, Oslo, the

†Department of Neurosurgery, St. Olav’s Hospital, Trondheim, the

‡Coast Hospital for Physical Medicine and Rehabilitation, Stavern, the

§Department of Physical Medicine and Rehabilitation, Ullevaal University Hospital, Oslo, the

∥Department of Neurosurgery, University North Norway, Tromsø, and the

¶Department of Biological and Medical Psychology, University of Bergen, Norway.

Acknowledgment date: September 18, 2002.

Acceptance date: October 28, 2002.

The manuscript submitted does not contain information about medical device(s)/drug(s). Federal and Foundation funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

Address reprint requests to Jens Ivar Brox, Department of Orthopaedics, National Hospital, 0027, Oslo, Norway. E-mail: jens.ivar.brox@rikshospitalet.no

© 2003 Lippincott Williams & Wilkins, Inc.