• Abhilasha Ramasamy, Mona L Martin, Steven I Blum, Hiltrud Liedgens, Charles Argoff, Rainer Freynhagen, Mark Wallace, Kelly P McCarrier, Donald M Bushnell, Noël V Hatley, and Donald L Patrick.
• Forest Research Institute, Jersey City, New Jersey.
• Pain Med. 2017 Jun 1; 18 (6): 1098-1110.

ObjectiveTo identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.DesignLiterature review of existing PRO measures.MethodsPublications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.ResultsThirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.ConclusionsThere is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials.© 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

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