article

The Neuropathic Pain Scale and its reliability

and validity for diabetic neuropathy
Tauqeer Ahmed Malik, Hussam Eddine Saleh Itani, Nashat Ali Gandoura
Pain is a subjective experience and as such is difficult to assess objectively. The
common method of assessment is to use a pain scale so that patients can rate
different aspects of their experience of pain. Neuropathic pain, which is caused
by a dysfunction of the nervous system and is often associated with the diabetic
foot, can be assessed using the Neuropathic Pain Scale. This article reviews the
literature for the Neuropathic Pain Scale to assess its reliability and validity in
identifying levels of neuropathic pain. The authors conclude that the NPS is a
valid and reliable tool.

ain is a sensation that the majority of us

will have experienced in varying degrees
throughout our lives. Various definitions of
pain have been used over the years. In 1986, the
International Association for the Study of Pain
(IASP)[1] described it as:
an unpleasant sensory or emotional experience
associated with actual or perceived tissue damage
or expressed in terms of such damage.

In Bonicas Management of Pain [2], it is argued

that the IASP should have included definitions of
acute, chronic, recurrent and cancer pain. In 2008,
the World Union of Wound Healing Societies
(WUWHS)[3] defined wound pain as:
a noxious symptom or unpleasant experience
directly related to an open skin ulcer.

Author
Dr Tauqeer Ahmed Malik is
a Senior Registrar G Surgery,
Diabetic Foot Surgeon and Wound
Care at the King Fahad Armed
Forces Hospital Jeddah, KSA; Dr
Nashat Ali Gandoura is Consultant
General and Diabetic Foot Surgeon
at, King Fahad Hospital in Jeddah,
KSA; Dr Hussam Eddine Saleh
Itani, Wound Care Consultant and
Educator, Dubai, UAE

12

Wound pain may arise from various wound

aetiologies, such as the diabetic foot, pressure ulcers
and arterial and venous leg ulcers[46]. Acute pain
is temporally related to injury. It is felt instantly,
it is localised, and it is often described as a sharp,
pinprick type of pain which eventually subsides
as the wound heals[7,8]. In contrast, chronic pain
is background pain that is persistent at rest and
between wound-related procedures, and extends
for more than three months or lasting longer than
a wound that is healing on a normal trajectory[7,9].
Pain is multidimensional, experienced by
an individual and not only involves physical

sensation, but also has a psychological impact [10,11].

Mood, personality, coping style, the degree of
preparation, uncertainty, control over the pain,
past experience of pain, and social and religious
influences are various psychological and social
factors that can affect an individuals ability to
cope with pain[10,12,13]. Carr [14] highlighted the
presence of bias among healthcare professionals
in their assessment of pain based on their
expectations of how certain individuals should
cope with pain. He concluded that the experience
of pain is influenced by age, past experience of
pain, gender, and culture, therefore, all need to
be considered while planning for appropriate
and effective care. However, pain and suffering
are private, internal events that cannot be
directly and empirically observed by clinicians,
or assessed via blood tests or X-rays [11], and as
expressed by McCaffery[12]:
pain is what the experiencing individual tells
you it is and exists when he/she says it does.
In order to understand pain, communication
between the patient and the clinician is mandatory.
This may help to achieve a correct diagnosis and
determine the intensity, quality and duration
of pain, as well as evaluating the effectiveness
of pain therapy[16]. Therefore, the assessment of
pain requires a psychosocial, behavioural and
organic approach, which encompasses not only
the severity of pain and related pathology, but
The Diabetic Foot Journal Middle East Vol 1 No 1 2015

The Neuropathic Pain Scale and its reliability and validity for diabetic neuropathy

also of the individual[17]. Failure to assess wound

pain may lead to significant distress for the
patient[18].
Pain assessment tools are generally simple to
use, efficient and minimally intrusive and are
used primarily for acute pain management in
hospital settings. They include: verbal rating
scales (VRS), numerical rating scales (NRS), and
visual analogue scales (VAS)[16]. The NRS asks the
patient to rate their pain from 0 to 10 (11 pointscale) or from 0 to 100 (101-point scale), with 0
equal to no pain and 10 or 100 equal to the worst
possible pain. NRSs are valid, reliable, easy to
administer and score, and include the Brief Pain
Inventory (BPI)[19], LANNS Pain Scale [20] and the
Neuropathic Pain Scale (NPS)[21,22]. This article
will consider the NPS in detail using a literature
review to identify studies that have evaluated its
effectiveness.

The Neuropathic Pain Scale

The IASP defines neuropathic pain (NP) as:
pain initiated or caused by a primary lesion
or dysfunction of the nervous system
and it is a group of neurological disorders
characterised by chronic pain and typically
includes reports of burning, hyperpathia, and
lancinating pain regardless of aetiology [23].
Peripheral neuropathy is one of the most common
complications of diabetes, and is associated
with long standing peripheral neuropathic pain
affecting the life of a patients with diabetic foot.
The NPS was developed by Galer and Jensen
in 1996 [21] to assess NP based on their clinical
experience of identifying the most frequent
words used by patients with NP to describe their
pain. The NPS includes two descriptors of pain
including intensity and unpleasantness, that have
previously been identified as global descriptors
of pain[24,25], and eight descriptors that assess
specific qualities of NP: sharp, hot, dull, cold,
sensitive, itchy, deep and surface pain. Each of
these 10 dimensions has a 0 to 10 NRS, in which
0 is equal to no pain and 10 equals the most
intense pain.

Psychometrics and clinimetrics

Psychometrics or clinimetrics is the process of
scientific development and evaluation of an
evidence-based clinical assessment tool, which
The Diabetic Foot Journal Middle East Vol 1 No 1 2015

assesses the accuracy, internal consistency,

reliability, and validity of a tool[2628]. Although
both terms have been used in the medical literature
search, the majority of new developments in scale
construction like new variations of the intraclass
correlation, item response theory, structural
equation modeling, and cognitive theories
are reported in the psychometric literature, so
continued use of clinimetrics not only leads
to confusion and misunderstanding, but cuts
the scale developer off from a long, rich, and
f lourishing literature [29]. Hence Streiner has
questioned the use of the term clinimetrics and
suggests that the term psychometrics might be
more useful[29].

Mood, personality,
coping style, the
degree of preparation,
uncertainty, control
over the pain, past
experience of pain, and
social and religious
influences are various
psychological and
social factors that can
affect an individuals
ability to cope with
pain.

Literature review
Validity
Validity of a measured tool determines whether the
tool truly measures what it claims to measure[30,31],
and it may be achieved by various means, such as by
how the test measures what it is meant to measure
(content validity), by asking the opinion of an
expert group (face validity), by comparing it with
results of other established pain assessment scales
(concurrent validity), by considering whether it is
able to predict pain-related outcomes (predictive
validity) or by questioning whether a test designed
to measure a construct described by a theory really
measures this construct (construct validity)[27].
There are a number of aspects of the NPS design
that suggest it is a valid tool. In 1996, Galer and
Jensen[21] enrolled 288 consecutive patients with
one of four NP conditions: post-herpetic neuralgia
(PHN), reflex sympathetic dystrophy (RSD),
traumatic peripheral nerve injury (TPNI), and
diabetic neuropathy (DN). The authors evaluated
the predictive validity of the NPS, using analysis of
variance (ANOVA) for each of the 10 descriptors.
The authors concluded that the NPS descriptors
were able to distinguish PHN from RSD, TPNI,
and DN, with PHN being described as more
sharp (F=5.74; P<0.01), more sensitive (F=12.63;
P<0.01), more itchy (F=14.07; P<0.01), and less
cold (F=21.36; P<0.01).
In a randomised controlled trial by Jensen
et al[22], 159 patients with diabetes-related foot
pain were randomly assigned to receive opioid
(controlled-released oxycodone) or placebo
for six weeks. NPS was administered before,
during, and after study treatment. The analysis
13

article

of covariance (ANCOVA) model and responder

analysis were used for the study outcome. The
authors concluded that, relative to placebo,
the opioid analgesic produced a statistically
significantly greater decrease in global pain
intensity (P<0.003), pain unpleasantness
(P<0.018), and sharp (P<0.028), dull (P<0.023),
and deep (P<0.015) pain sensations. Responder
analysis, using ANCOVA analysis, indicated
a higher rate of response to opioid analgesic
conditions relative to placebo for the ratings
of intense (P<0.012), unpleasant (P<0.019),
deep (P<0.039) and surface pain (P<0.021).
Although not statistically significant, more
patients responded to the analgesia than the
placebo on the ratings of sharp, hot, dull, and
cold pain. These findings support the use of the
NPS for characterising the multidimensional
nature of the NP experience and for detecting
changes in NP with treatment.
Further, Rog et al[32] gave the NPS to 141 patients
with multiple sclerosis (MS), together with the
short-form McGill Pain Questionnaire (SFMPQ),
the Hospital Anxiety and Depression Scale
(HADS), and the short-form 36 Health Survey
(SF-36). The patients chose a mean of 8.0 (range
1 to 10, SD=1.9) of the 10 NPS items compared
with the mean of 8.5 items chosen from the 15
SFMPQ descriptors (range 0 to 15, SD=4.0). Thus
NPS shows significantly higher content validity
than the SFMPQ. This could be explained in part
because VAS is an integral part of SFMPQ[33], and
patients with MS may find it difficult to use VAS
because of their disabilities. Patients used a mean
of 81% of the NPS descriptors in defining their
NP compared with a mean of 59% of the SFMPQ
items signifying higher face validity compared with
SFMPQ. However, regarding construct validity,
the NPS demonstrated convergent validity with the
SFMPQ and discriminant validity with the HADS
and SF-36 mood and health status instruments.
Studies by Fishbain et al [34] and Victor et
[35]
al , further demonstrated the good level of
predictive validity of the NPS, showing an
ability to discriminate between non-neuropathic
and neuropathic pain. However, the studies by
Galer and Jensen[21], Fishbain et al [34] and Victor
et al[35] were all clinical, non-randomised, noncontrolled and non-blind. For further accuracy of
results from these studies, a randomised doubleblind approach is warranted.
14

Reliability
Reliability is an important measure in assessing
the accuracy of NPS and refers to an assessment
of error measurement, which means that the
test is likely to give the same results on repeated
occasions [36]. The reliability is calculated using
the intra-class correlation coefficient (ICC)[37].
The values for reliability coefficients range from 0
to 1.0. A coefficient of 0 means no reliability and
1.0 means perfect reliability. Since all tests have
some error, reliability coefficients never reach 1.0.
Generally, if the reliability of a standardised test is
above 0.80, it is said to have very good reliability;
if it were below 0.50, it would not be considered
a very reliable test [38]. Therefore, the minimum
acceptable value for reliability is set to 0.70 [39].
The reliability of NPS came from a sub-study by
Rog et al[32] who administered NPS to 36 patients
with MS together with SFMPQ, HADS, and
SF-36. The authors tested the short-term test or
re-test reliability by providing NPS to the patients
at home by post after telephone calls, or in the
clinic or the day-case ward. For the long-term test
or re-test reliability, NPS was posted to all those
patients approximately three weeks after the initial
completion of questionnaires. This included a
written reminder to answer questionnaires solely
for the pain identified at initial completion. In the
test or re-test analysis only those patients whose
pain remained the same were included. In the shortterm test re-test reliability 45% initially completed
the NPS at home, 25% in clinic, and 2% on the
day-case ward, demonstrating good agreement of
postal and hospital completion. While in the longterm test or re-test reliability, 90% repeat NPSs
were completed and returned. The ICC for the
individual NPS items varied between 0.45 and
0.78, with overall ICC for the total NPS score being
0.71, just above the acceptable value of 0.7, showing
the reliability of the NPS tool.
Sensitivity is defined as the proportion of the
people with disease who have a positive test result,
and specificity is the proportion of people without
disease who have a negative test result[41]. The
NPS needs to be sensitive, specific, and reliable to
changes in the pain experience over time. Galer
and Jensen[21] tested the psychometric properties
of the NPS using intravenous lidocaine and
phentolamine infusion on a total of 78 patients.
To determine the sensitivity of the NPS descriptors
to treatment, a series of repeated measures of
The Diabetic Foot Journal Middle East Vol 1 No 1 2015

The Neuropathic Pain Scale and its reliability and validity for diabetic neuropathy

ANOVA were performed with treatment (lidocaine

versus phentolamine) and time (immediately
before versus immediately post-treatment) as the
independent variables, and responses to each of
the NPS descriptors as the dependable variables.
The authors concluded that two treatments were
effective, on average, for reducing pain, with most
pain qualities decreasing post-treatment. Lidocaine
was found to be particularly effective for unpleasant
and deep qualities of pain, whereas lidocaine
and phentolamine were similarly effective for the
remaining qualities of NP. Moreover, the authors
did mention the limitations of their second study
in generalising the results, as the study was not
performed in a randomised, double-blind fashion
rather the study was done to assess the ability of the
NPS to detect the treatment effect, not to assess
the efficacy of the therapies.
The study by Galer and Jensen[21] not only
indicates high sensitivity and specificity of the
NPS, but also suggests discriminant validity
(an ability for changes to individual dimensions
to reflect specific pain treatments and provide
evidence of their distinct value[34]). Jensen et al[42]
studied the use of the lidocaine patch 5% in
patients with peripheral NP, lower back pain (LBP),
and osteoarthritis with exception of cold pain
in the LBP group. Each of the NPS descriptors
showed significant change after using a lidocaine
patch with relative larger changes in intensity,
unpleasantness, sharp and deep pain, and relatively
smaller changes in cold, sensitive and itchy pain.
The results support the potential use of the NPS for
assessing the patterns of changes in pain qualities
that can be observed after treatment for pain.
Similarly, Galer et al[43] deployed the NPS as the
only pain assessment tool specifically designed to
measure the distinct components of NP, and Argoff
et al[44], studied the impact of the lidocaine patch
5% on pain associated with PHN, DN and LBP.
Both studies demonstrated the improved sensitivity
and reliability of the NPS in differentiating various
pain states and also in assessing the treatment
outcomes for various pain qualities associated with
given pain states. However, in contrast, Lynch et
al[45] showed adenosine affecting only five of the
NPS descriptors, suggesting that it has a different
treatment mechanism.
The overall usability is important for any
screening tool and to become accepted it needs
to save users time and offer practicality, resulting
The Diabetic Foot Journal Middle East Vol 1 No 1 2015

in better patient care and cost savings [26]. For the

readability and clarity of the tools, it is important
that users are able to easily understand, interpret
and comprehend the questionnaire in order to
self-administer the tool. Galer and Jensen [21]
and Jensen et al [42] addressed these concerns
and provided explanations and instructions,
prompting the patients to note that pain can have
many different qualities and then asked them to
rate their pain according to 10 descriptors of NPS.
However, Backonja and Stacy[23] argued against
this by showing that in the results from the NPS
and Neuropathic Pain Questionnaire (NPQ )[46],
the burning pain from NPQ and hot pain from
NPS were essentially the same feeling of hot and
burning, but the frequency and severity of these
two descriptors were different.

Conclusion
Screening tools should be easy and quick to
perform, acceptable to the patients and healthcare
workers, and have good reproducibility and validity
(Stratton et al, 2004). Precision is necessary,
as patients who are in pain may not want to
spend time, possibly in an uncomfortable position,
completing lengthy charts or questionnaires[47].
However, diagnostic tests are seldom 100%
accurate and both false positive and false negative
results can occur[48].
The NPS is the first pain measure designed
specifically for NP. It assesses various qualities
of NP and has sensitivity and specificity in
relation to NP[21,42,45]. Its short-term test/re-test
and long-term test/re-test reliabilities have been
demonstrated by Rog et al[32] in a study of patients
with MS. They demonstrated that the NPS
could discriminate between different categories
of NP, and that NPS scores changed in response
to various treatments. However, the NPS cannot
discriminate NP from non-NP, and its ability to
do so remains untested [46].
The literature search has shown that the NPS is a
valid and reliable tool. It captures a large proportion
of the patients own description of their NP and it is
largely free from ambiguity. It can be administered
both by post and in hospital, and it shows both
convergent and discriminant validity with other
commonly-used scales[32]. Thus it is evident that the
NPS is sensitive and specific to the neuropathic pain
experience in the clinical setting, demonstrating a
range of psychometric principles.
n
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article

Precision is necessary,
as patients who are in
pain may not want to
spend time, possibly
in an uncomfortable
position, completing
lengthy charts or
questionnaires.

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The Diabetic Foot Journal Middle East Vol 1 No 1 2015