Literature Review

Variation in Eligibility Criteria From Studies of Radiculopathy due to a Herniated Disc and of Neurogenic Claudication due to Lumbar Spinal Stenosis

A Structured Literature Review

Genevay, Stephane MD^*†; Atlas, Steve J. MD, MPH^‡; Katz, Jeffrey N. MD, MSc^†

From the *Division of Rheumatology, University Hospitals of Geneva, Geneva, Switzerland; †Department of Orthopaedic Surgery and Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Harvard Medical, Boston MA; and ‡General Medicine Division, Massachusetts General Hospital, Boston MA.

Acknowledgment date: March 5, 2009. Revision date: May 29, 2009. Acceptance date: July 13, 2009.

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

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.

Supported by NIH/NIAMS P60 AR 47782 and NIH/NIAMS K24 02123 (to J.N.K.); and supported in part by a grant from (P60 AR048094) to the Multidisciplinary Clinical Research Center in Musculoskeletal Diseases from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (to S.J.A.).

Address correspondence and reprint requests to Stéphane Genevay, MD, Division of Rheumatology, University Hospitals of Geneva, 26 Av Beau-Séjour, 1211 Geneva 14, Switzerland; E-mail: [email protected]

Spine 35(7):p 803-811, April 1, 2010. | DOI: 10.1097/BRS.0b013e3181bc9454

Study Design.

A structured literature review.

Summary of the Background Data.

Widely recognized classification criteria for rheumatologic disorders have resulted in well-defined patient populations for clinical investigation.

Objective.

We sought to determine whether similar criteria were needed for back pain disorders by examining variability in eligibility criteria in published studies.

Methods.

Studies involving radiculopathy due to lumbar herniated disc (HD) and for neurogenic claudication due to lumbar spinal stenosis (LSS) were identified. Randomized controlled trials published between January 1, 2006 and October 1, 2008 in select peer reviewed journals were retrieved, their eligibility criteria were identified and categorized.

Results.

Twelve eligible HD studies were identified. Thirteen unique categories of eligibility criteria were identified with a mean of 3.9 (±2.0) and a range from 0 to 8 categories per study. More categories were present for studies that included nonsurgical (5.6 ± 2.5) treatment for studies with only surgical treatment (2.6 ± 1.7) P = 0.04). Seven LSS studies met eligibility criteria, and 9 unique categories were identified. A mean of 5.0 (±2.2) categories with a range from 2 to 7 was used per study.

Conclusion.

Wide variation in the number and type of eligibility criteria from randomized clinical trials of well defined back pain syndromes was identified. These results support the need for developing and disseminating international classification criteria for these clinical conditions.

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Variation in Eligibility Criteria From Studies of Radiculopathy due to a Herniated Disc and of Neurogenic Claudication due to Lumbar Spinal Stenosis