Abstract
Effective outcome measures are a key component in the rapid and efficient development of analgesic treatments. In particular, recent interest in mechanism-based approaches to the classification and treatment of pain disorders has highlighted the utility of validated tools for the measurement of neuropathic and non-neuropathic pain qualities, such as the revised Short-form McGill Pain Questionnaire (SF-MPQ-2).The SF-MPQ-2 has been validated in chronic pain populations, but not in patients with acute low back pain. To evaluate the possible utility of the SF-MPQ-2 in clinical trial patients with acute low back pain, we conducted validation analyses with data from a randomized, double-blind, parallel-group study of immediate-release formulations of oxycodone vs. tapentadol for relief of acute low back pain. A confirmatory factor analysis (CFA) was performed on pre-treatment data for four subscales: Continuous pain, Intermittent pain, Neuropathic pain, and Affective descriptors. The following additional analyses were conducted to assess validity: Internal consistency was measured using alpha coefficients. Convergent validity was assessed via correlations with other baseline measures of similar constructs. Correlations with primary efficacy endpoints assessed predictive validity. Bias was evaluated by correlations with demographic variables. Responsiveness was evaluated by testing change from baseline for each treatment group. Results showed that the subscales of the SF-MPQ-2 (1) fit the a priori factor structure specified for the CFA, (2) showed high internal consistency, (3) displayed good convergent validity, (4) had no unexpected biases, and (5) were responsive to change associated with analgesic treatment. SF-MPQ-2 scores were not predictive of treatment efficacy for low back pain, but were correlated with relief from leg pain in a subset of patients. We conclude that the SF-MPQ-2 is a valid instrument for use in clinical trials to assess pain qualities in patients with acute low back pain. These analyses were supported by a grant from Janssen Pharmaceuticals.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
