The International Spinal Cord Injury Pain Extended Data Set (ISCIPEDS)
The working-group consists of:
Eva Widerström-Noga, DDS PhD (Chair); Fin Biering-Sørensen, MD, PhD; Thomas N Bryce, MD; Diana D Cardenas, MD, MHA; Nanna Brix Finnerup, MD, PhD; Mark P Jensen, PhD; J Scott Richards, PhD; Elizabeth J Richardson, PhD, MSPH; Philip Siddall, MD, PhD
Our interdisciplinary working group consists of members with published research expertise in the area of spinal cord injury (SCI) related pain. The members have expertise with regard to the clinical condition of pain, pain taxonomy, psychophysics of pain, psychology, epidemiology and assessment of pain and represent the Executive Committee of the International Spinal Cord Injury Standards and Data Sets (ASIA/ISCoS; Biering-Sørensen) and major organizations with an interest in SCI-related pain (i.e., the International Spinal Cord Society (ISCoS), American Spinal Injury Association (ASIA), Association of Spinal Cord Injury Professionals (ASCIP), American Pain Society (APS) and International Association for the Study of Pain (IASP)). Most of the committee members have memberships in several of these organizations.
Pain after SCI is a significant problem for those who experience it as well as for their healthcare providers because of its persistent nature. Pain in people with SCI is classified in broad categories as nociceptive, neuropathic (at- or below level of injury), other or unknown (Bryce et al., 2012 a,b). Neuropathic pain may be associated with evoked pain, such as allodynia or hyperalgesia (Eide et al., 1996; Finnerup et al., 2001). The neuropathic pains are rarely completely eliminated by available treatment interventions but can be meaningfully reduced in some people (Siddall et al., 2006; Cardenas et al., 2013).Because of the persistent nature of pain associated with SCI, there is a need to understand and assess both pain and associated psychological factors.
The clinical presentation of pain after SCI often includes multiple concomitant pain problemsthat are superimposed upon various physical impairments and consequences of injury. This presents unique challenges in the assessment of both pain and associated psychosocial factors and ultimately for clinical management.
The overall purpose of the International Spinal Cord Injury Pain Data Sets (ISCIPDS) is to standardize the collection and reporting of pain in the SCI population. The ISCIPDS contains a basic(ISCIPBDS)and an extended (ISCIPEDS)data set.The ISCIPBDS contains a minimal amount of clinically relevant information concerning pain that can be collected in the daily practice of healthcare professionals with expertise in SCI. The first version of the International Spinal Cord Injury Pain Basic Data Set ISCIPBDSwas published in 2008 (Widerstrom-Noga et al., 2008) and a revised version ISCIPBDS v2.0 (Widerstrom-Noga et al., 2014) in 2014. The revised version was shortened to increase its clinical utility and to reflect the new SCI pain taxonomy (Bryce et al., 2012 a,b).It is adopted by the National Institute of Health, National Institute of Neurological Disorders and Stroke (NINDS), Common Data Elements (CDEs) as a supplemental/highly recommended dataset to be collected in clinical SCI pain research
( (Jakemanet al., in press)
The ISCIPEDS is directly based on the pain problems identified in the ISCPBDS and is primarily intended to provide guidance regarding the assessment ofpain, and associated sensory function and psychosocial factors in clinical pain studies and trials. Consistent evaluation of these factors will facilitate research collaboration between clinical centers and thus expedite the development of beneficial treatments. The use of comparable sets of outcome measures in research studies will increase efficiency and facilitate collaborations, translation, interpretation, and application of results.
The ISCIPEDS is intended to be collected by researchers or healthcare professionals involved in research studies and who are familiar with SCI. Data should be collected by interview (dependent on the recommended mode of administration for a specific instrument) andexamination.
The ISCIPEDS includes several important assessment components divided in 4 sections: (1) Pain symptom assessment including individual variables related to the temporal course, severity, unpleasantness, tolerability of pain, as well as questionnaires related to the pain type and symptom severity. This section is divided into: A. Overall pain(assessments are intended to provide an overall assessment of all pain that a person may experience).B. Each pain problem(assessments are intended to be performed for each separate pain problem identified in the ISCIPBDS); and C. Recommended questionnaires intended to provide supplemental information as appropriate for a specific purpose or interest. (2) Sensory assessment to detect and quantify common sensory abnormalities, including light touch, pinprick, and cold sensation in a neuropathic pain area; (3) Treatments used in the past 12 months and for ongoing treatments, dose (if appropriate), frequency of treatment, any adverse effects, and a rating of global impression of change; and (4) Psychosocial domains and comorbid conditions including outcomes, mediating factors, or comorbid conditions (e.g., depression, anxiety, quality of life). Forms for all assessment variables except for questionnaires can be found in the Appendix.
Pain symptoms and signs are particularly important to evaluate in populations, such as SCI, where pain is typically heterogeneous, persistent and often severe. Symptoms and signs associated with neuropathic pain may not only facilitate a better understanding of the clinical condition but may also provide a foundation for subgroup analyses in clinical trials and thus facilitate future mechanisms-based treatment interventions (Baron et al., 2012; Demant et al., 2014 ). The pain symptom measures included in the ISCIPEDS are intended to be simple, and clinically useful. They are divided into measures that can be used to assess overall pain and measures that are more useful if asked for a specific pain problem. There is also a section of recommendedpain questionnaires that assess the presence and severity of pain symptoms and have data supporting their utility after SCI. These measures are intended to provide supplemental information as appropriate for a specific purpose or interest.The sensory measures are intended to detect and quantify common sensory abnormalities, including mechanical allodynia, mechanical hyperalgesia, and thermal allodynia commonly associated with neuropathic pain types.
Information regarding a persons’ previous and current experience with various treatment interventions is important both for the planning of clinical studies and facilitates screening of potential participants of a clinical trial. The ISCIPEDSis designed to capture information regarding both past (last 12 months) and current treatments. Due to possible recall biases, the effectiveness of past treatments are not captured in detail but only whether a person has had the treatment in the past 12 months and if it was helpful or not, or unknown. For current, ongoing treatments, more details are captured, including the dose (if appropriate), frequency of treatment, any adverse effects, and a rating of global impression of change (Guy 1976).
The psychosocial domains that researchers should consider assessing in their studies of SCI pain include outcome variables, mediating variables and comorbid conditions that would be of interest to those seeking to develop, test, or expand biopsychosocial models of SCI-related pain.The ISCIPEDSworking group selected those domains, and identified potential measures of those domains, as a function of (a) their relevance to individuals with SCI and chronic pain and (b) the existence of published findings that support the validity of the measures selected in samples of individuals with SCI, and as much as possible (c) their availability in the public domain.
There is a vast array of outcomes measures that have been recommended for use in neuropathic pain research (Haanpӓӓ et al., 2011) and in SCI pain research specifically(Bryce et al., 2007).Reviewing all such measuresis beyond the scope of the ISCIPEDS.We recommend that researchers carefully examine the appropriateness of any measure they might like to use with respect to utility in the SCI chronic pain population. For example, standard measures for pain-related outcomes may have content that is inappropriate for persons with SCI, or that can be misleading if endorsed (e.g., unusual sensory experiences). The instruments in the ISCIPEDS were selected in part to minimize that problem. The reader is also referred to the SCIRE ( and NINDS CDEs ( websites where an extensive numberof outcomemeasuresare evaluated with respect to their applicability and psychometric properties. While the measures reviewed in these loci are not focused only on pain per se, they offer other resources for SCI researchers who want to use the most valid scales, particularly those which are being proposed for adoption across studies.
Acknowledgements:We thank William Bauman, Susan Charlifue, and Vanessa Noonan for valuable comments and suggestions.
- PAIN SYMPTOM ASSESSMENT:
- Overall pain (assessment includes all pain problems but could also be assessed for each pain problem (previously identified by the ISCIPBDS) if appropriate).
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VARIABLE NAME:Number of days with pain in the last 7 days including today
DESCRIPTION:This variable specifies the total number of days with pain during the last 7 days, including today.
CODES:0 – none
1 – one day
2 – two days
3 – three days
4 – four days
5 – five days
6 – six days
7 – seven days
Unknown
COMMENTS: “Today” is the day the individual answers the question regardless time of day.The duration of pain during the day does not matter in answering this question.
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VARIABLE NAME:Average pain intensity of the worst pain in the last week
DESCRIPTION:A 0 – 10 Numerical Rating Scale (ranging from 0 = “No pain” to a maximum of 10 = “The most intense pain imaginable”) of average pain intensity for the worst pain problem the respondents experience). Please note that “last week” specifically refers to the last seven days including today.
CODES:0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
COMMENTS:Pain intensity is the most common pain domain assessed in research and clinical settings.Although different rating scales have proven to be valid for assessing pain intensity, including the Numerical Rating Scale (NRS), the Verbal Rating Scale (VRS), and the Visual Analogue Scale (VAS), the 0 – 10 NRS has the most strengths and fewest weaknesses of available measures (Jensen & Karoly, 2000).Moreover the 0 – 10 NRS has been recommended by the IMMPACT consensus group for use in pain clinical trials (Dworkin et al., 2005) and by the 2006 NIDRR SCI Pain outcome measures consensus group (Bryce et al., 2007).
The seven day time frame was selected to balance the need to assess pain over a long enough epoch to capture usual pain, against the need to keep the time frame short enough to maximize recall accuracy.
The instruction and endpoints used were designed to differentiate between pain intensity and pain unpleasantness (Dannecker et al., 2007). For example, the intensity of pain is how strong the pain feels and the unpleasantness of pain is how disturbing the pain is. In order to better understand the difference between pain intensity and unpleasantness one can substitute the word “sound” for “pain”. Pain intensity is analogous to the loudness of a sound while unpleasantness is analogous to the aversiveness of a sound not necessarily related to its loudness.
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VARIABLE NAME:Average pain unpleasantness in the last week
DESCRIPTION:A 0 – 10 Numerical Rating Scale (ranging from 0 = “Not at all unpleasant” to a maximum of 10 = “The most unpleasant pain imaginable”) of average pain unpleasantness for (up to) three pain problems (the three worst pain problems respondents experience). Please note that “last week” specifically refers to the last seven days including today.
CODES:0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
COMMENTS: Pain is a result of sensory, cognitive, and affective dimensions, and the emotional dimension can be evaluated separately from intensity (Price et al., 1987). Although different rating scales have proven to be valid for assessing pain intensity, including the Numerical Rating Scale (NRS), the Verbal Rating Scale (VRS), and the Visual Analogue Scale (VAS), the 0 – 10 NRS has the most strengths and fewest weaknesses of available measures (Jensen & Karoly, 2000).
The instruction and endpoints used were designed to differentiate between pain intensity and pain unpleasantness (Dannecker et al., 2007). For example, the intensity of pain is how strong the pain feels and the unpleasantness of pain is how disturbing the pain is. In order to better understand the difference between pain intensity and unpleasantness one can substitute the word “sound” for “pain”. Pain intensity is analogous to the loudness of a sound while unpleasantness is analogous to the aversiveness of a sound not necessarily related to its loudness.
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VARIABLE NAME:Number of days with manageable/tolerablepain in the last 7 days including today
DESCRIPTION:This variable specifies the total number of days with pain during the last 7 days, including today.
CODES:0 – none
1 – one day
2 – two days
3 – three days
4 – four days
5 – five days
6 – six days
7 – seven days
Unknown
COMMENTS:“Today” is the day the individual answers the question regardless time of day. The duration of manageable/tolerable pain during the day does not matter in answering this question.
Manageable or tolerable pain is a construct reported by Zelman et al., 2004, and not specific to pain after SCI. Focus group methodology has suggested that manageable or tolerable pain is pain that permits concentration on something other than the pain, perhaps by using a treatment or self-remedy that “takes the edge off” pain and allows performance of daily activities or “getting something done.” Other factors associated with manageable pain are lower levels of negative mood, feeling well enough to socialize and not experiencing excessive adverse effects of ongoing treatments including medication.
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- Each pain problem(to be assessed for each pain problem previously identified by the ISCIBPDS)
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VARIABLE NAME:Pain intensity in present moment
DESCRIPTION:A 0 – 10 Numerical Rating Scale (ranging from 0 = “No pain” to a maximum of 10 = “The most intense pain imaginable”) of present pain intensity for (up to) three pain problems (the three worst pain problems respondents experience). Please note that “present” specifically refers to this moment.
CODES:0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
COMMENTS: Pain intensity is the most common pain domain assessed in research and clinical settings.Although different rating scales have proven to be valid for assessing pain intensity, including the Numerical Rating Scale (NRS), the Verbal Rating Scale (VRS), and the Visual Analogue Scale (VAS), the 0 – 10 NRS has the most strengths and fewest weaknesses of available measures (Jensen & Karoly, 2000).Moreover the 0 – 10 NRS has been recommended by the IMMPACT consensus group for use in pain clinical trials (Dworkin et al., 2005) and by the 2006 NIDRR SCI Pain outcome measures consensus group (Bryce et al., 2007).
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VARIABLE NAME:How long does your pain usually last?
DESCRIPTION:This variable provides an estimate of the duration of pain. Some pain types are very brief andmay be felt several times per day. This question refers to the duration of each separate pain event.
CODES:One minute or less
More than one minute but less than one hour
At least one hour, but less than 24 hours
At least 24 hours but not continuous
Constant or continuous
Unknown
COMMENTS:The duration of pain can be defined when a specific pain follows a predictable pattern. If no predictable pattern for a specific pain exists, the answer “unknown” is given.
VARIABLE NAME:When during the day is the pain most intense?
DESCRIPTION:This variable identifies the diurnal peak in pain intensity.
CODES:Morning
Afternoon
Evening
Night
Unpredictable; pain is not consistently more intense at any one time of day
COMMENTS:“Morning” is between 6.01 am and 12.00 am (06.01 and 12.00);“Afternoon” is between 12.01 am and 6.00 pm (12.01 and 18.00); “Evening” is between 6.01 pm and 12.00 pm (18.01 and 24.00); “Night” is between 0.01am and 6.00 am (00.01 and 06.00)
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- Recommended questionnaires
Instruments for the assessment of pain type or pain symptom severity are listed in Table 1.
Nociceptive pain assessment
The assessment for nociceptive pain will be assessed as in non-SCI populations.
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- SENSORY ASSESSMENT
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VARIABLE NAME:Dynamic light touch
DESCRIPTION:Sensation rated as normal (compared to a control area in a non-affected skin area), absent (no sensation felt), hypoesthesia (decreased sensation compared to control area), hyperesthesia (increased sensation compared to control area), allodynia (the touch provokes pain), other (changed sensation that cannot be categorized otherwise). If allodynia is present the pain is rated on a 0 – 10 Numerical Rating Scale (ranging from 0 = “No pain” to a maximum of 10 = “Pain as bad as you can imagine”).
COMMENTS:Can be assessed by light stroking the skin with an innocuous moving stimuli, e.g. a cotton wisp, cotton wool tip, or a brush (e.g. Somedic standardized brush, Sweden) of approximately 2 cm with a speed of 1-2 cm/sec. (Rolke et al. 2006).
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VARIABLE NAME:Pinprick
DESCRIPTION:Sensation rated as normal (compared to a control area in a non-affected skin area), absent (no sensation felt), hypoalgesia (decreased pain sensation compared to control area), hyperalgesia (increased pain sensation compared to control area), other (changed sensation that cannot be categorized otherwise). If hyperalgesia is present the pain is rated on a 0 – 10 Numerical Rating Scale (ranging from 0 = “No pain” to a maximum of 10 = “Pain as bad as you can imagine”).
COMMENTS:Can be assessed using a disposable safety pin or calibrated monofilaments (Rolke et al., 2006)
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VARIABLE NAME:Cold
DESCRIPTION: Sensation rated as normal (compared to a control area in a non-affected skin area), absent (no sensation felt), hypoesthesia (decreased sensation compared to control area), hyperesthesia (increased sensation compared to control area), allodynia (the cold provokes pain), other (changed sensation that cannot be categorized otherwise). If allodynia is present the pain is rated on a 0 – 10 Numerical Rating Scale (ranging from 0 = “No pain” to a maximum of 10 = “Pain as bad as you can imagine”).
COMMENTS:Can be assessed using a cold thermoroll (Somedic Sweden) of 20 or 25C, a piece of cold metal, an ice cube or an acetone droplet. For determination of cold detection and cold pain thresholds, thermal tests can be performed using thermo testers (TSA, Medoc, Israel or MSA, Somedic, Sweden) (Rolke et al. 2006).