From the 2006 NIDRR SCI Measures Meeting 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

Background/Objectives: To examine the reliability, validity, sensitivity, and practicality of various outcome measures for pain after spinal cord injury (SCI), and to provide recommendations for specific measures for use in clinical trials. Data Sources: Relevant articles were obtained through a search of MEDLINE, EMBASE, CINAHL, and PubMed databases from inception through 2006. Study Selection: The authors performed literature searches to find articles containing data relevant to the reliability and validity of each pain outcome measure in SCI and selected non-SCI populations. Data Extraction: After reviewing the articles, an investigator extracted information utilizing a standard template. A second investigator reviewed the chosen articles and the extracted pertinent information to confirm the findings of the first investigator. Data Synthesis: Taking into consideration both the quantity and quality of the studies analyzed, judgments on reliability and validity of the measures were made by the two investigators. Based upon these judgments, recommendations were formulated for use of specific measures in future clinical trials. In addition, for a subset of measures a voting process by a larger group of SCI experts allowed formulation of recommendations including determining which measures should be incorporated into a minimal dataset of measures for clinical trials and which ones need revision and further validity and reliability testing before use. Conclusions: A 0–10 Point Numerical Rating Scale (NRS) is recommended as the outcome measure for pain intensity after SCI, while the 7-Point Guy/Farrar Patient Global Impression of Change (PGIC) scale is recommended as the outcome measure for global improvement in pain. The SF-36 single pain interference question and the Multidimensional Pain Inventory (MPI) or Brief Pain Inventory (BPI) pain interference items are recommended as the outcome measures for pain interference after SCI. Brush or cotton wool and at least one high-threshold von Frey filament are recommended to test mechanical allodynia/hyperalgesia while a Peltier-type thermotester is recommended to test thermal allodynia/hyperalgesia. The International Association for the Study of Pain (IASP) or Bryce-Ragnarsson pain taxonomies are recommended for classification of pain after SCI, while the Neuropathic Pain Scale (NPS) is recommended for measuring change in neuropathic pain and the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) for quantitating neuropathic and nociceptive pain discrimination.

[1]  Mary Elizabeth Lynch,et al.  Intravenous adenosine alleviates neuropathic pain: a double blind placebo controlled crossover trial using an enriched enrolment design , 2003, PAIN®.

[2]  Misha-Miroslav Backonja,et al.  Neuropathic Pain Questionnaire—Short Form , 2003, The Clinical journal of pain.

[3]  D. Davis.  Validity and Reliability: Part I , 2004, Neonatal Network.

[4]  J. Lowery,et al.  Assessing Persistent Pain and Its Relation to Affective Distress, Depressive Symptoms, and Pain Catastrophizing in Patients with Chronic Wounds: A Pilot Study , 2004, American journal of physical medicine & rehabilitation.

[5]  J. Farrar,et al.  Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale , 2001, PAIN.

[6]  H. Baxter.  Understanding research: 2. Ensuring reliability and validity. , 2001, Journal of wound care.

[7]  M. Jensen,et al.  Catastrophizing is associated with pain intensity, psychological distress, and pain-related disability among individuals with chronic pain after spinal cord injury , 2002, Pain.

[8]  J. Farrar,et al.  Core outcome measures for chronic pain clinical trials: IMMPACT recommendations , 2003, Pain.

[9]  J. Riley,et al.  Empirical test of the factor structure of the West Haven-Yale Multidimensional Pain Inventory. , 1999, The Clinical journal of pain.

[10]  J. Farrar,et al.  Core outcome domains for chronic pain clinical trials: IMMPACT recommendations , 2003, Pain.

[11]  Bernard Laurent,et al.  Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4) , 2005, Pain.

[12]  M. Jensen,et al.  Assessing Global Pain Severity by Self-Report in Clinical and Health Services Research , 2000, Spine.

[13]  Deborah A Taylor,et al.  Classification of pain following spinal cord injury , 1997, Spinal Cord.

[14]  J. Richards,et al.  Spinal Cord Injury Rehabilitation: State of the Science , 2006, American journal of physical medicine & rehabilitation.

[15]  M. Devivo,et al.  Interference due to pain following spinal cord injury: important predictors and impact on quality of life , 2002, Pain.

[16]  Blair H. Smith,et al.  The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. , 2005, The journal of pain : official journal of the American Pain Society.

[17]  S. Harkins,et al.  Combined Use of Experimental Pain and Visual Analogue Scales in Providing Standardized Measurement of Clinical Pain , 1987 .

[18]  S. Braver,et al.  The measurement of clinical pain intensity: a comparison of six methods , 1986, Pain.

[19]  M. Bennett,et al.  Gabapentin in the treatment of neuropathic pain , 2004, Palliative medicine.

[20]  M. Rowbotham,et al.  The Lidocaine Patch 5% Effectively Treats All Neuropathic Pain Qualities: Results of a Randomized, Double-Blind, Vehicle-Controlled, 3-Week Efficacy Study With Use of the Neuropathic Pain Scale , 2002, The Clinical journal of pain.

[21]  S. Rutkowski,et al.  Pain characteristics in patients admitted to hospital with complications after spinal cord injury. , 2003, Archives of physical medicine and rehabilitation.

[22]  D. Turk,et al.  The West Haven-Yale Multidimensional Pain Inventory (WHYMPI) , 1985, Pain.

[23]  J. Putzke,et al.  Interrater Reliability of the International Association for the Study of Pain and Tunks’ Spinal Cord Injury Pain Classification Schemes , 2003, American Journal of Physical Medicine & Rehabilitation.

[24]  Debora Winders Davis,et al.  Reliability and Validity: Part II , 2004, Neonatal Network.

[25]  J. Atkinson,et al.  Measurement of pain: Patient preference does not confound pain measurement , 1981, Pain.

[26]  D. Borsboom,et al.  The concept of validity. , 2004, Psychological review.

[27]  L. Rajmil.  Health measurement scales. A practical guide to their development and use, 3rd ed , 2005 .

[28]  D. Turk,et al.  Assessment of the impact of pain and impairments associated with spinal cord injuries. , 2002, Archives of physical medicine and rehabilitation.

[29]  B. Galer,et al.  Development and preliminary validation of a pain measure specific to neuropathic pain , 1997, Neurology.

[30]  George Varghese,et al.  Psychosocial factors in chronic spinal cord injury pain , 1991, Pain.

[31]  E. Svensson,et al.  Lack of interchangeability between visual analogue and verbal rating pain scales: a cross sectional description of pain etiology groups , 2005, BMC medical research methodology.

[32]  M. Devivo,et al.  Pain classification following spinal cord injury: The utility of verbal descriptors , 2002, Spinal Cord.

[33]  R. Melzack,et al.  Pain assessment in adult patients , 2006 .

[34]  M. Dowda,et al.  Differentiating sensory and affective-sensory pain descriptions in patients undergoing magnetic resonance imaging for persistent low back pain , 2004, Pain.

[35]  J. Paice,et al.  Validity of a verbally administered numeric rating scale to measure cancer pain intensity. , 1997, Cancer nursing.

[36]  D. Dudgeon,et al.  The short-form McGill Pain Questionnaire in chronic cancer pain. , 1993, Journal of pain and symptom management.

[37]  E. Skovlund,et al.  A comparison of pain rating scales by sampling from clinical trial data. , 2000, The Clinical journal of pain.

[38]  B. Galer,et al.  The pain quality assessment scale: assessment of pain quality in carpal tunnel syndrome. , 2006, The journal of pain : official journal of the American Pain Society.

[39]  D. Cook,et al.  Current concepts in validity and reliability for psychometric instruments: theory and application. , 2006, The American journal of medicine.

[40]  M. Allegri,et al.  [Validation of the Italian version of the "Neuropathic Pain Scale" and its clinical applications]. , 2002, Minerva anestesiologica.

[41]  D. Turk,et al.  Exacerbation of chronic pain following spinal cord injury. , 2004, Journal of neurotrauma.

[42]  W. Downie,et al.  Studies with pain rating scales. , 1978, Annals of the rheumatic diseases.

[43]  M. Devivo,et al.  Predictors of Pain 1 Year Post-Spinal Cord Injury , 2001, The journal of spinal cord medicine.

[44]  G. Fava,et al.  A discussion on the role of clinimetrics and the misleading effects of psychometric theory. , 2005, Journal of clinical epidemiology.

[45]  M. Buonocore,et al.  Validazione della «Scala del Dolore Neuropatico» (SDN) e sue applicazioni terapeutiche , 2002 .

[46]  M. Pollack,et al.  Outcome assessment. , 1993, Critical care medicine.

[47]  S. Linton,et al.  A psychometric evaluation of the Swedish version of the Multidimensional Pain Inventory (MPI‐S): a gender differentiated evaluation , 1999, European journal of pain.

[48]  M. Bennett,et al.  The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs , 2001, Pain.

[49]  A. Stubhaug,et al.  Cold allodynia and hyperalgesia in neuropathic pain: the effect of N-methyl-d-aspartate (NMDA) receptor antagonist ketamine – a double-blind, cross-over comparison with alfentanil and placebo , 2003, Pain.

[50]  Walter Grassi,et al.  Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale , 2004, European journal of pain.

[51]  C. Cleeland,et al.  Pain assessment: global use of the Brief Pain Inventory. , 1994, Annals of the Academy of Medicine, Singapore.

[52]  K. Spratt,et al.  Pain Intensity Assessment in Older Adults: Use of Experimental Pain to Compare Psychometric Properties and Usability of Selected Pain Scales With Younger Adults , 2004, The Clinical journal of pain.

[53]  P. Bijur,et al.  Reliability and validity of a visual analog scale for acute abdominal pain in the ED. , 2002, The American journal of emergency medicine.

[54]  J. Bolton,et al.  Assessing the clinical significance of change scores recorded on subjective outcome measures. , 2004, Journal of manipulative and physiological therapeutics.

[55]  D. Bouhassira,et al.  Effects of IV morphine in central pain: A randomized placebo-controlled study , 2002, Neurology.

[56]  G. Moseley,et al.  Why do people with complex regional pain syndrome take longer to recognize their affected hand? , 2004, Neurology.

[57]  M. Jensen,et al.  One- and two-item measures of pain beliefs and coping strategies , 2003, Pain.

[58]  M. Jensen,et al.  Partner responses to pain behaviors are associated with depression and activity interference among persons with chronic pain and spinal cord injury. , 2006, The journal of pain : official journal of the American Pain Society.

[59]  J. Middleton,et al.  A proposed algorithm for the management of pain following spinal cord injury , 2006, Spinal Cord.

[60]  M. van Kleef,et al.  What Is a Meaningful Pain Reduction in Patients With Complex Regional Pain Syndrome Type 1? , 2003, The Clinical journal of pain.

[61]  T. Jensen,et al.  Pain and dysesthesia in patients with spinal cord injury: A postal survey , 2001, Spinal Cord.

[62]  R. M. Mason,et al.  Comparison of fixed interval and visual analogue scales for rating chronic pain , 1975, European Journal of Clinical Pharmacology.

[63]  Misha-Miroslav Backonja,et al.  Development of a Neuropathic Pain Questionnaire , 2003, The Clinical journal of pain.

[64]  Évaluation fonctionnelle de la douleur chronique chez le patient blessé médullaire , 2006 .

[65]  G. Lankhorst,et al.  Clinimetrics in rehabilitation medicine: current issues in developing and applying measurement instruments 1. , 2005, Journal of rehabilitation medicine.

[66]  P. Watson,et al.  The development and validation of a Greek version of the short‐form McGill Pain Questionnaire , 2000, European journal of pain.

[67]  P. Tugwell,et al.  Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial. , 1995, Arthritis and rheumatism.

[68]  C. Warms,et al.  Classification of chronic pain associated with spinal cord injuries. , 2002, Archives of physical medicine and rehabilitation.

[69]  D. Bouhassira,et al.  Intravenous lidocaine in central pain , 2000, Neurology.

[70]  D. Turk,et al.  Internal consistency, stability, and validity of the spinal cord injury version of the multidimensional pain inventory. , 2006, Archives of physical medicine and rehabilitation.

[71]  D. Turk,et al.  Psychosocial Profiles of People With Pain Associated With Spinal Cord Injury: Identification and Comparison With Other Chronic Pain Syndromes , 2004, The Clinical journal of pain.

[72]  S. Dworkin,et al.  Grading the severity of chronic pain , 1992, Pain.

[73]  S. Cathcart,et al.  Reliability of pain threshold measurement in young adults , 2004, The Journal of Headache and Pain.

[74]  P. Roberts,et al.  Reliability and validity in research. , 2006, Nursing standard (Royal College of Nursing (Great Britain) : 1987).

[75]  D. Cardenas,et al.  Gender and minority differences in the pain experience of people with spinal cord injury. , 2004, Archives of physical medicine and rehabilitation.

[76]  B. Dudgeon,et al.  Describing pain with physical disability: narrative interviews and the McGill Pain Questionnaire. , 2005, Archives of physical medicine and rehabilitation.

[77]  N. Blumen,et al.  Characterization of chronic pain and somatosensory function in spinal cord injury subjects , 2001, Pain.

[78]  N. Harland,et al.  Development of the Coping Strategies Questionnaire 24, a Clinically Utilitarian Version of the Coping Strategies Questionnaire , 2003 .

[79]  Francis J. Keefe,et al.  The use of coping strategies in chronic low back pain patients: Relationship to patient characteristics and current adjustment , 1983, Pain.

[80]  K. Grafton,et al.  Test-Retest Reliability of the Short-Form McGill Pain Questionnaire: Assessment of Intraclass Correlation Coefficients and Limits of Agreement in Patients With Osteoarthritis , 2005, The Clinical journal of pain.

[81]  B. Galer,et al.  Assessment of pain quality in chronic neuropathic and nociceptive pain clinical trials with the Neuropathic Pain Scale. , 2005, The journal of pain : official journal of the American Pain Society.

[82]  D. Price,et al.  The validation of visual analogue scales as ratio scale measures for chronic and experimental pain , 1983, Pain.

[83]  J. Cissik.  Prediction of high naevus count in a healthy UK population to estimate melanoma risk , 2015, BDJ.

[84]  Jacques Fermanian,et al.  Development and validation of the Neuropathic Pain Symptom Inventory , 2004, Pain.

[85]  R. Poole,et al.  Pregabalin for the treatment of postherpetic neuralgia , 2003, Neurology.

[86]  M. Jensen,et al.  Postsurgical pain outcome assessment , 2002, PAIN.

[87]  M. Devivo,et al.  Age And Spinal Cord Injury: An Emphasis On Outcomes Among The Elderly , 2003, The journal of spinal cord medicine.

[88]  K. Ragnarsson,et al.  Reliability of the Bryce/Ragnarsson Spinal Cord Injury Pain Taxonomy , 2006, The journal of spinal cord medicine.

[89]  I. L. Johannesen,et al.  Intravenous Lidocaine Relieves Spinal Cord Injury Pain: A Randomized Controlled Trial , 2005, Anesthesiology.

[90]  G. Waddell,et al.  A comparison of cognitive measures in low back pain: statistical structure and clinical validity at initial assessment , 1991, Pain.

[91]  P. London.  Injury , 1969, Definitions.

[92]  S. Rutkowski,et al.  Pain report and the relationship of pain to physical factors in the first 6 months following spinal cord injury , 1999, Pain.

[93]  G. Cruccu,et al.  EFNS guidelines on neuropathic pain assessment , 2004, European journal of neurology.

[94]  J. Turner,et al.  Chronic pain problems in individuals with spinal cord injuries. , 1999, Seminars in clinical neuropsychiatry.

[95]  S. Rutkowski,et al.  A longitudinal study of the prevalence and characteristics of pain in the first 5 years following spinal cord injury , 2003, Pain.

[96]  A. Nava,et al.  Use of the leeds assessment of neuropathic symptoms and signs questionnaire in patients with fibromyalgia. , 2003, Seminars in arthritis and rheumatism.

[97]  P. Grigg,et al.  Three-dimensional load analysis of indentation stimulators , 2003, Journal of Neuroscience Methods.

[98]  P. Hansson,et al.  Dynamic mechanical allodynia: On the relationship between temporo-spatial stimulus parameters and evoked pain in patients with peripheral neuropathy , 2005, Pain.

[99]  K. Raichle,et al.  The reliability and validity of pain interference measures in persons with spinal cord injury. , 2006, The journal of pain : official journal of the American Pain Society.

[100]  T. Friede,et al.  Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis , 2005, Neurology.

[101]  P. Kennedy,et al.  Factors associated with acute and chronic pain following traumatic spinal cord injuries , 1997, Spinal Cord.

[102]  David L Streiner,et al.  "Precision" and "accuracy": two terms that are neither. , 2006, Journal of clinical epidemiology.

[103]  Ronald Melzack,et al.  The short-form McGill pain questionnaire , 1987, Pain.

[104]  Elif Kocasoy Orhan,et al.  Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. , 2004, The journal of pain : official journal of the American Pain Society.

[105]  F. Keefe,et al.  Sickle cell disease pain: relation of coping strategies to adjustment. , 1989, Journal of consulting and clinical psychology.

[106]  K. Andrews,et al.  The effect of changes in temperature and humidity on the accuracy of von Frey hairs , 1993, Journal of Neuroscience Methods.

[107]  M. Hanley,et al.  Pain interference in persons with spinal cord injury: classification of mild, moderate, and severe pain. , 2006, The journal of pain : official journal of the American Pain Society.

[108]  S. Canavero,et al.  Intravenous Subhypnotic Propofol in Central Pain: A Double-Blind, Placebo-Controlled, Crossover Study , 2004, Clinical neuropharmacology.

[109]  R. Melzack.  The McGill Pain Questionnaire: Major properties and scoring methods , 1975, PAIN.

[110]  D. Turk,et al.  Types and effectiveness of treatments used by people with chronic pain associated with spinal cord injuries: influence of pain and psychosocial characteristics , 2003, Spinal Cord.

[111]  PJ Siddall,et al.  Pain following spinal cord injury , 2001, Spinal Cord.

[112]  A. Arntz,et al.  Psychometric properties of the Multidimensional Pain Inventory, Dutch language version (MPI-DLV). , 1999, Behaviour research and therapy.

[113]  Bonita J Sawatzky,et al.  Prevalence of shoulder pain in adult- versus childhood-onset wheelchair users: a pilot study. , 2005, Journal of rehabilitation research and development.

[114]  R. Treede,et al.  Quantitative sensory testing: a comprehensive protocol for clinical trials , 2006, European journal of pain.

[115]  J. Bell-Krotoski,et al.  The repeatability of testing with Semmes-Weinstein monofilaments. , 1987, The Journal of hand surgery.

[116]  K. Ragnarsson.  Management of pain in persons with spinal cord injury. , 1997, The journal of spinal cord medicine.

[117]  G. Bove,et al.  Mechanical sensory threshold testing using nylon monofilaments: The pain field’s “Tin Standard” , 2006, Pain.

[118]  C. Chapman,et al.  Correlation of change in visual analog scale with pain relief in the ED. , 2005, The American journal of emergency medicine.

[119]  D. Streiner,et al.  Health Measurement Scales: A practical guide to thier development and use , 1989 .

[120]  F. Keefe,et al.  Theoretical perspectives on the relation between catastrophizing and pain. , 2001, The Clinical journal of pain.

[121]  M. Devivo,et al.  Quality of life after spinal cord injury caused by gunshot. , 2001, Archives of physical medicine and rehabilitation.

[122]  Gregory T. Smith.  On construct validity: issues of method and measurement. , 2005, Psychological assessment.

[123]  J. Womersley,et al.  Measurement of the W boson mass at the LHC , 1997, hep-ph/9711304.

[124]  P. Watson,et al.  Reliability and sensitivity measures of the Greek version of the short form of the McGill Pain Questionnaire , 2001, European journal of pain.