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.
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