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Surgical or Nonoperative Treatment for Lumbar Spinal Stenosis?: A Randomized Controlled Trial

Malmivaara, Antti MD, PhD*; Slätis, Pär MD, PhD∥; Heliövaara, Markku MD, PhD†; Sainio, Päivi PT, MSc†; Kinnunen, Heikki MD§; Kankare, Jyrki MD, PhD§; Dalin-Hirvonen, Nina MD‡; Seitsalo, Seppo MD, PhD∥; Herno, Arto MD, PhD¶; Kortekangas, Pirkko MD, PhD#; Niinimäki, Timo MD, PhD**; Rönty, Hannu MD**; Tallroth, Kaj MD, PhD∥; Turunen, Veli MD††; Knekt, Paul PhD‡‡; Härkänen, Tommi PhD†; Hurri, Heikki MD, PhD∥; for the Finnish Lumbar Spinal Research Group

doi: 10.1097/01.brs.0000251014.81875.6d
Randomized Trial

Study Design. A randomized controlled trial.

Objectives. To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis.

Summary of Background Data. No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis.

Methods. Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0–100). Data on the intensity of leg and back pain (scales, 0–10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months.

Results. Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3–18.4), 1.7 in leg pain (95% CI, 0.4–3.0), and 2.3(95% CI, 1.1–3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8–14.9) 1.5 in leg pain (95% CI, 0.3–2.8), and 2.1 in back pain (95% CI, 1.0–3.3). Walking ability, either reported or measured, did not differ between the two treatment groups.

Conclusions. Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.

The effectiveness of decompressive surgery for lumbar spinal stenosis was assessed. A total of 94 patients were randomized into a surgical or nonoperative treatment group. At the 2-year follow-up, the mean differences in favor of surgery were: 7.8 in Oswestry disability index (scale, 0–100), 1.5 in leg pain (scale 0–10), and 2.1 in back pain. Walking ability, either reported or measured, did not differ between the two treatment groups. The results indicate a favorable effect of decompressive surgery both on leg and low back pain and on overall disability.

From the *Finnish Office for Health Technology Assessment, National Research and Development Center, FinOHTA/Stakes, Helsinki; †National Public Health Institute, Helsinki; ‡Department of Radiology, Helsinki University Hospital, Helsinki; §Department of Orthopaedic Surgery, Helsinki University Hospital, Helsinki; ∥ORTON Orthopedic Hospital, Invalid Foundation, Helsinki; ¶Department of Physiatrics, Kuopio University Hospital, Kuopio; #Department of Neurosurgery, Turku University Hospital, Turku; **Department of Orthopaedic Surgery, Oulu University Hospital, Oulu; ††Department of Orthopaedic Surgery, Kuopio University Hospital, Kuopio; and ‡‡Helsinki Psychotherapy Study, Social Insurance Institution, Helsinki, Finland.

Supported by the Finnish Office for Health Technology Assessment, and the participating hospitals.

Acknowledgment date: October 12, 2004. First revision date: July 8, 2005. Second revision date: December 21, 2005. Third revision date: March 13, 2006. Acceptance date: March 14, 2006.

The manuscript submitted does not contain information about medical device(s)/drug(s).

Institutional 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 correspondence and reprint requests to Antti Malmivaara, MD, PhD, Finnish Office for Health Technology Assessment, Lintulahdenkuja 4, 00530 Helsinki, Finland; E-mail: antti.malmivaara@stakes.fi

© 2007 Lippincott Williams & Wilkins, Inc.