HPE Chronic pain – part two | Page 6

or reaching for a shelf. The questionnaire consists of 36 points (36 points indicating 100% ability to perform all 12 tasks in daily life; 0 points indicating 0% ability to perform all 12 tasks in daily life and therefore maximal impairment). A score of 80–100% (29–36 points) is considered to indicate normal functionality, 60–79% (22–28 points) moderate functionality, and <60% (<21 points) is considered as relevant impairment of functionality. 28 Pain Assessment for Lower Back-Symptoms (PAL-S) and Impacts (PAL-I) These questionnaires were developed recently to incorporate patient perspective of benefit of a treatment in cLBP trials. 29 The PAL-I and PAL-S were developed in accordance with US FDA guidance for PROMs to be used for label claims of patientreported improvements in symptoms and impact of medications to treat cLBP. The PAL-S is a recent PRO assessment tool designed to specifically reflect the pain sensations experienced by patients with cLBP. The qualitative evidence collected during this study supports the assessment of both the neuropathic- and nonneuropathic sensations in these patients. The variations of severity and disturbances observed among the specific concepts of pain underscore their importance in evaluating how patients feel and function and are therefore relevant and important in the assessment of potential treatment benefit. The instrument had a crosscultural patient input. The PAL-S reflects the specific symptoms of pain associated with cLBP and is not a generic measure. 30 The PAL-I provides a single total impact score on a scale of 0 to 3, with higher scores indicating greater impact due to cLBP. Patients score each of the nine items with response options of: Not at all limited (score 0); Limited a little (score 1); Limited a lot (score 2); Did not do because of my LBP (score 3); or patients can opt-out of an item (Did not do for TABLE 1 Low back pain concepts PAL-I 31 1 Limited your walking 2 Limited your sitting 3 Limited your standing 4 Limited your lifting 5 Limited your sleep 6 Limited your social activities (going out and seeing friends) 7 Limited travelling (daily driving and taking trips) 8 Affected your climbing up or down stairs (at home or at other locations) 9 Limited your turning, twisting, or bending other reasons) (Table 1). The mean score for all scored items (excluding opt-out items) represents the single total impact score. PAL-I and PAL-S are designed for use in clinical trials to treat cLBP. Although not specifically developed for use in clinical practice, both of these might be useful in assessing patients’ status associated with their cLBP and to provide helpful information to clinicians considering the next steps of care. 31 PAL-I demonstrated content validity, that is, the items in the instruments are relevant and representative of the cLBP experience based on input from patients with cLBP. PAL-I demonstrated one-week test–retest reliability, convergent validity with relevant components of existing instruments, and appropriate item-level performance, scale structure and scoring. The psychometric measurement properties have been validated and prove useful in assessing impairment in a clinical setting, by providing the opportunity to tailor individual patient therapy and improve patient– physician communication and patient outcomes. 31 Conclusions Functionality must be the main consideration when evaluating the efficacy of cLBP treatments. There is no validated or perfect instrument for measuring functionality, but clinicians can use any of a range of questionnaires mentioned previously in daily clinical practice. Fulfilment of individualised functional goals of treatment can be considered as the main outcome to assess functionality, including factors such as the ability to sleep and accomplishing day-to-day activities (including work) as surrogate dimensions. It is evident that more outcome measures are needed and there might be discrepancies between different pain measurement tools and different populations; nevertheless, measuring functionality is fundamental in cLBP and might be more objective and goal-oriented than assessment of pure pain intensity. References 1 Manchikanti L et al. Epidemiology of low back pain in adults. Neuromodulation 2014;17 Suppl 2:3–10. 2 Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. 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