CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: The International SCI Data Sets
CRF: International SCI Pain Basic Data Set Version 2.0

Displaying 1 - 16 of 16
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C06071 Pain interfere mood scale PainIntrferMoodScl Scale that evaluates to what extent pain has interfered with the participants mood. Scale that evaluates to what extent pain has interfered with the participants mood. In general how much has pain interfered with your overall mood in the past week? 1;10;2;3;4;5;6;7;8;9 1;10;2;3;4;5;6;7;8;9 Numeric Values

Choose one for each pain classification (e.g., worst pain, second worst pain, etc.)
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date of data collection Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 21:00:23.88 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Free-Form Entry

C06072 Pain interfere sleep scale PainIntrferSleepScale Scale that evaluates to what extent pain has interfered with the participant's sleep. Scale that evaluates to what extent pain has interfered with the participant's sleep. In general how much has pain interfered with your ability to get a good night's sleep? 1;10;2;3;4;5;6;7;8;9 1;10;2;3;4;5;6;7;8;9 Numeric Values

Choose one for each pain classification (e.g., worst pain, second worst pain, etc.)
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06056 Pain past seven day indicator PainPstSvnDyInd Indicator of the presence of any type of pain during the last 7 days, including today. Indicator of the presence of any type of pain during the last 7 days, including today. Have you had any pain during the last seven days including today? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Pain is defined by the International Association for the Study of Pain (IASP) as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage" (Merskey & Bogduk, 1994). The seven day interval was chosen in order to be able to capture current pain and both constant and intermittent chronic pain that may be clinically relevant and to have the same time frame in all data sets.

Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Merskey H, Bogduk N. (Eds.). (1994). Classification of chronic pain: Description of chronic pain syndromes and definition of pain terms. Seattle: IASP Press. Adult Supplemental?Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06073 Pain treatment indicator PainTreatmtInd Indicator for whether the participant is using or receiving any treatment for the pain experienced. Indicator for whether the participant is using or receiving any treatment for the pain experienced. Are you using or receiving any Treatment for your pain problem? Yes;No;Unknown Yes;No;Unknown Alphanumeric

By "treatment" is meant any prescribed or non-prescribed medical, surgical, psychological, or physical treatment that the patient is using or receiving for pain that has been present the last seven days to alleviate his/her pain/pains. This variable may include chronic and intermittent drug treatment, physical therapy, relaxation training, nerve blocks etc.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06057 Pain different problem number PainDiffrntProbNum Number of different pain problems an individual perceives that he or she has experienced during the last seven days including today. A "pain problem" is defined by the person himself as a pain that has a specific character. Number of different pain problems an individual perceives that he or she has experienced during the last seven days including today. A "pain problem" is defined by the person himself as a pain that has a specific character. If yes how many different pain problems did you have? Please note that the time period during the last week applies to all pain interference questions. 1;2;3;4;5 or more 1;2;3;4;5 or more Alphanumeric

Only answered if person reports pain during the last seven days. Please note that one pain problem can be located in one or several areas.
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Subject Alphanumeric

The participant or subject identifiers or IDs should be assigned by the study.
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult;Pediatric Supplemental-Highly Recommended 1.00 2014-06-05 13:10:49.0 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets 255

Free-Form Entry

C06058 Pain problem grade PainProbGrade Grade for the pain problem that indicates whether the person is describing their worst pain problem, their second worst pain problem, or their third worst pain problem. Grade for the pain problem that indicates whether the person is describing their worst pain problem, their second worst pain problem, or their third worst pain problem. Please describe your three worst pain problems Alphanumeric

All three classifications should be used if the person reports three or more pain problems in the last 7 days.
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets 255

Free-Form Entry

C06059 Pain location anatomic site PainLocAntmicSite Anatomic site on the body where the pain is experienced Anatomic site on the body where the pain is experienced Pain locations sites Head;Throat;Neck;Shoulder;Upper arm;Elbow;Forearm;Wrist;Hand/Fingers;Chest;Abdomen;Pelvis/Genitalia;Upper back;Lower back;Buttocks;Hip;Anus;Upper leg/Thigh;Knee;Shin;Calf;Ankle;Foot/Toes Head;Throat;Neck;Shoulder;Upper arm;Elbow;Forearm;Wrist;Hand/Fingers;Chest;Abdomen;Pelvis/Genitalia;Upper back;Lower back;Buttocks;Hip;Anus;Upper leg/Thigh;Knee;Shin;Calf;Ankle;Foot/Toes Alphanumeric

Can be more than one, so check all that apply
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06060 Pain location indicator PainTypLatLoc Indicates if the participant experienced pain in the particular location described jointly by the laterality and anatomic site Indicates if the participant experienced pain in the particular location described jointly by the laterality and anatomic site Pain locations sites Right;Midline;Left Right;Midline;Left Alphanumeric

Can be more than one, so check all that apply
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06061 Pain type PainTyp Type of pain present. Eight broad types of pain are specified based on the new SCI pain taxonomy that has been published and validated (Bryce TN, Biering-Sorensen F, Finnerup NB, Cardenas DD, Defrin R, Lundeberg T et al.
International spinal cord injury pain (ISCIP) classification: part I. Background and description. Spinal Cord 2012; 50: 413–417. and Bryce TN, Biering-Sorensen F, Finnerup NB, Cardenas DD, Defrin R, Ivan E et al.
International spinal cord injury pain (ISCIP) classification: part 2. Initial validation using vignettes. Spinal Cord 2012; 50: 404–412.).
Type of pain present. Eight broad types of pain are specified based on the new SCI pain taxonomy that has been published and validated. Type of Pain Neuropathic- At-level SCI;Neuropathic- Below-level SCI;Neuropathic- Other;Nociceptive-musculoskeletal;Nociceptive-other;Nociceptive-visceral;Other pain type;Unknown Neuropathic- At-level SCI;Neuropathic- Below-level SCI;Neuropathic- Other;Nociceptive-musculoskeletal;Nociceptive-other;Nociceptive-visceral;Other pain type (not nociceptive or neuropathic);Unknown Alphanumeric

Check all that apply. Seven broad types of pain are specified based on pain types identified in previous SCI pain taxonomies (Donovan et al., 1982; Siddall et al., 2000; Bryce & Ragnarsson, 2001; Cardenas et al., 2002; Bryce et al., 2012a,b) and based on prevalence in the SCI population. Please note that the ASIA Impairment scale (AIS) and the associated dermatomal map (Kirshblum et al., 2011) are to be used as integral parts of the SCI pain classification. Nociceptive pains that are less prevalent or not directly related to SCI and not categorized as musculoskeletal or visceral can be classified as 'Other (Nociceptive)'. Pains that are not associated with a lesion or disease affecting the spinal cord or nerve roots yet are nevertheless neuropathic can be classified as 'Other (Neuropathic)'. 'Unknown' should be used when it is not possible to classify the pain into one of the categories listed above. 'Unknown' pain refers only to pain of unknown etiology and not to pains with both nociceptive and neuropathic qualities, nor to defined pain syndromes of unknown etiology, like fibromyalgia. For pains that seem to have both nociceptive and neuropathic qualities the two components should be classified separately. Defined pain syndromes of unknown etiology (for example, fibromyalgia) should be coded as 'Other'

Bryce TN, Ragnarsson KT. Epidemiology and classification of pain after spinal cord injury. Top Spinal Cord Inj Rehabil. 2001;7:1-17. Cardenas DA, Turner JA, Warms CA, Marshall HM. Classification of chronic pain associated with spinal cord injuries. Arch Phys Med Rehabil. 2002;83:1708-14.Donovan WH, Dimitrijevic MR, Dahm L, Dimitrijevic M. Neurophysiological approaches to chronic pain following spinal cord injury. Paraplegia. 1982;20:135-46. Siddall PJ, Yezierski RP, Loeser JD. Pain following spinal cord injury: clinical features, prevalence, and taxonomy. International Association for the Study of Pain Newsletter. 2000;3:3-7. WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Multiple Pre-Defined Values Selected

C06062 Pain intensity average past week scale PainIntnstAvgPstWkScale Scale of the participant's/subject's pain intensity in the past week. A 0 – 10 Numerical Rating Scale (ranging from 0 = "No pain" to a maximum of 10 = "Pain as bad as you can imagine") of average pain intensity for the past week Numerical Rating Scale (ranging from 0 = "No pain" to a maximum of 10 = "Pain as bad as you can imagine") of average pain intensity for the past week Average pain intensity in the last week 0;1;2;3;4;5;6;7;8;9;10 No Pain;;;;;;;;;;pain as bad as you can imagine Numeric Values

Choose one. Please note that "last week" specifically refers to the last seven days including today.
Supplemental - Highly Recommended

Bryce TN, Budh CN, Cardenas DD, Dijkers M, Felix ER, Finnerup NB, Kennedy P, Lundeberg T, Richards JS, Rintala DH, Siddall P, Widerstrom-Noga E. Pain after spinal cord injury: an evidence-based review for clinical practice and research. Report of the National Institute on Disability and Rehabilitation Research Spinal Cord Injury Measures meeting. J Spinal Cord Med. 2007;30:421-40. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allan RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott, MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9-19. Jensen MP, Karoly P. (2001). Self-report scales and procedures for assessing pain in adults. In DC Turk & R Melzack (Eds.), Handbook of pain assessment, 2nd edition. New York: Guilford Publications, pp. 15-34. WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06063 Pain onset date PainOnstDate Date (and time, if applicable and known) the particular pain problem started Date (and time, if applicable and known) the particular pain problem started Date of onset for pain Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Free-Form Entry

C02411 Laterality type LatTyp Laterality type relative to the anatomic site of the body examined or affected Laterality type relative to the anatomic site of the body examined or affected Pain locations sites Left;Right;Midline Left;Right;Midline Alphanumeric

Choose one

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-08-28 16:08:00.453 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06070 Pain interfere daily activity scale PainIntrferDlyActScale Scale that evaluates to what extent pain has interfered with the participant's daily activities. Scale that evaluates to what extent pain has interfered with the participant's daily activities. In general how much has pain interfered with your day to day activities in the last week? 1;10;2;3;4;5;6;7;8;9 1;10;2;3;4;5;6;7;8;9 Numeric Values

Choose one for each pain classification (e.g., worst pain, second worst pain, etc.)
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06000 Site identifier number SiteIDNum Unique identification number given to the study site to distinguish the location where data is recorded. Unique identification number given to the study site to distinguish the location where data is recorded. Site Alphanumeric

The site identifiers or IDs should be assigned by the study.
Supplemental - Highly Recommended

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. Adult Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Set Version 2.0 The International SCI Data Sets The International SCI Data Sets 255

Free-Form Entry

CSV