The International Spinal Cord Injury Pain Extended Data Set (Version 1.0).

OBJECTIVES: The objective of this study was to develop the International Spinal Cord Injury Pain Extended Data Set (ISCIPEDS) with the purpose of guiding the assessment and treatment of pain after spinal cord injury (SCI). SETTING: International. METHODS: The ISCIPEDS was reviewed by members of the International SCI Data Sets Committee, the International Spinal Cord Society Executive and Scientific Committees, American Spinal Injury Association and American Pain Society Boards, and the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain, individual reviewers and societies. RESULTS: The working group recommended four assessment domains for the ISCIPEDS: (i) Pain symptoms including variables related to pain type, temporal course, severity, unpleasantness, tolerability of pain and questionnaires assessing pain type and symptom severity; (ii) Sensory signs to detect and quantify sensory abnormalities commonly associated with neuropathic pain, including dynamic mechanical and thermal allodynia, and hyperalgesia; (iii) Treatments (ongoing and past 12 months); and (iv) Psychosocial factors and comorbid conditions. CONCLUSION: The ISCIPEDS was designed to be used together with the International SCI Pain Basic Data Set and provide a brief yet thorough assessment of domains related to chronic pain in individuals with SCI. The data set includes pain-relevant self-reported assessments, questionnaires and sensory examinations. The recommendations were based on (i) their relevance to individuals with SCI and chronic pain, (ii) the existence of published findings supporting the utility of the selected measures for use in individuals with SCI, and to the greatest extent possible (iii) their availability in the public domain free of charge.

The International Spinal Cord Injury Pain Basic Data Set (version 2.0).

OBJECTIVES: To revise the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) based on new developments in the field and on suggestions from the spinal cord injury (SCI) and pain clinical and research community. SETTING: International. METHODS: The ISCIPBDS working group evaluated suggestions regarding the utility of the ISCIPBDS and made modifications in response to these and to significant developments in the field. The revised ISCIPBDS (version 2.0) was reviewed by members of the Executive Committee of the International SCI Standards and Data Sets, the International Spinal Cord Society (ISCoS) Executive and Scientific Committees, the American Spinal Injury Association and American Pain Society Boards and the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain, individual reviewers and societies and the ISCoS Council. RESULTS: The ISCIPBDS (version 2.0) is significantly shortened but still contains clinically relevant core questions concerning SCI-related pain. The revisions include an updated SCI pain classification, omission of three questions regarding temporal pain pattern and three pain interference questions. The remaining three pain interference questions concern perceived interference with activities, mood and sleep for overall pain rather than for individual pain problems and are scored on a 0 to 10 scale.

Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury.

STUDY DESIGN: Two randomized, double-blind, placebo-controlled trials. OBJECTIVE: To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI). SETTING: United States and Canada. METHODS: Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women). RESULTS: The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments. CONCLUSION: Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.

International Spinal Cord Injury Urinary Tract Infection Basic Data Set.

OBJECTIVES: To develop an International Spinal Cord Injury (SCI) Urinary Tract Infection (UTI) Basic Data Set presenting a standardized format for the collection and reporting of a minimal amount of information on UTIs in daily practice or research. SETTING: International working group. METHODS: The draft of the Data Set developed by a working group was reviewed by the Executive Committee of the International SCI Standards and Data Sets, and later by the International Spinal Cord Society (ISCoS) Scientific Committee and the American Spinal Injury Association (ASIA) Board. Relevant and interested scientific and professional (international) organizations and societies (∼40) were also invited to review the data set, and it was posted on the ISCoS and ASIA websites for 3 months to allow comments and suggestions. The ISCoS Scientific Committee, Executive Committee and ASIA Board received the data set for final review and approval. RESULTS: The International SCI UTI Basic Data Set includes the following variables: date of data collection, length of time of sign(s)/symptom(s), results of urine dipstick test for nitrite and leukocyte esterase, urine culture results and resistance pattern. The complete instructions for data collection and the data form itself are freely available on the website of ISCoS (http://www.iscos.org.uk).

International Spinal Cord Injury Pain (ISCIP) Classification: Part 2. Initial validation using vignettes.

STUDY DESIGN: International validation study using self-administered surveys. OBJECTIVES: To investigate the utility and reliability of the International Spinal Cord Injury Pain (ISCIP) Classification as used by clinicians. METHODS: Seventy-five clinical vignettes (case histories) were prepared by the members of the ISCIP Classification group and assigned to a category by consensus. Vignettes were incorporated into an Internet survey distributed to clinicians. Clinicians were asked, for each vignette, to decide on the number of pain components present and to classify each using the ISCIP Classification. RESULTS: The average respondent had 86% of the questions on the number of pain components correct. The overall correctness in determining whether pain was nociceptive was 79%, whereas the correctness in determining whether pain was neuropathic was 77%. Correctness in determining if pain was musculoskeletal was 84%, whereas for visceral pain, neuropathic at-level spinal cord injury (SCI) and below-level SCI pain it was 85%, 57% and 73%, respectively. Using strict criteria, the overall correctness in determining pain type was 68% (versus an expected 95%), but with maximally relaxed criteria, it increased to 85%. CONCLUSIONS: The reliability of use of the ISCIP Classification by clinicians (who received minimal training in its use) using a clinical vignette approach is moderate. Some subtypes of pain proved challenging to classify. The ISCIP should be tested for reliability by applying it to real persons with pain after SCI. Based on the results of this validation process, the instructions accompanying the ISCIP Classification for classifying subtypes of pain have been clarified.

International spinal cord injury pain classification: part I. Background and description. March 6-7, 2009.

STUDY DESIGN: Discussion of issues and development of consensus. OBJECTIVE: Present the background, purpose, development process, format and definitions of the International Spinal Cord Injury Pain (ISCIP) Classification. METHODS: An international group of spinal cord injury (SCI) and pain experts deliberated over 2 days, and then via e-mail communication developed a consensus classification of pain after SCI. The classification was reviewed by members of several professional organizations and their feedback was incorporated. The classification then underwent validation by an international group of clinicians with minimal exposure to the classification, using case study vignettes. Based upon the results of this study, further revisions were made to the ISCIP Classification. RESULTS: An overall structure and terminology has been developed and partially validated as a merger of and improvement on previously published SCI pain classifications, combined with basic definitions proposed by the International Association for the Study of Pain and pain characteristics described in published empiric studies of pain. The classification is designed to be comprehensive and to include pains that are directly related to the SCI pathology as well as pains that are common after SCI but are not necessarily mechanistically related to the SCI itself. CONCLUSIONS: The format and definitions presented should help experienced and non-experienced clinicians as well as clinical researchers classify pain after SCI.

Reliability and validity of the International Spinal Cord Injury Basic Pain Data Set items as self-report measures.

OBJECTIVE: To evaluate the psychometric properties of a subset of International Spinal Cord Injury Basic Pain Data Set (ISCIBPDS) items that could be used as self-report measures in surveys, longitudinal studies and clinical trials. SETTING: Community. METHODS: A subset of the ISCIBPDS items and measures of two validity criteria were administered in a postal survey to 184 individuals with spinal cord injury (SCI) and pain. The responses of the participants were evaluated to determine: (1) item response rates (as an estimate of ease of item completion); (2) internal consistency (as an estimate of the reliability of the multiple-item measures); and (3) concurrent validity. RESULTS: The results support the utility and validity of the ISCIBPDS items and scales that measure pain interference, intensity, site(s), frequency, duration and timing (time of day of worst pain) in individuals with SCI and chronic pain. The results also provide psychometric information that can be used to select from among the ISCIBPDS items in settings that require even fewer items than are in the basic data set.

The international spinal cord injury pain basic data set.

OBJECTIVE: To develop a basic pain data set (International Spinal Cord Injury Basic Pain Data Set, ISCIPDS:B) within the framework of the International spinal cord injury (SCI) data sets that would facilitate consistent collection and reporting of pain in the SCI population. SETTING: International. METHODS: The ISCIPDS:B was developed by a working group consisting of individuals with published evidence of expertise in SCI-related pain regarding taxonomy, psychophysics, psychology, epidemiology and assessment, and one representative of the Executive Committee of the International SCI Standards and Data Sets. The members were appointed by four major organizations with an interest in SCI-related pain (International Spinal Cord Society, ISCoS; American Spinal Injury Association, ASIA; American Pain Society, APS and International Association for the Study of Pain, IASP). The initial ISCIPDS:B was revised based on suggestions from members of the Executive Committee of the International SCI Standards and Data Sets, the ISCoS Scientific Committee, ASIA and APS Boards, and the Neuropathic Pain Special Interest Group of the IASP, individual reviewers and societies and the ISCoS Council. RESULTS: The final ISCIPDS:B contains core questions about clinically relevant information concerning SCI-related pain that can be collected by health-care professionals with expertise in SCI in various clinical settings. The questions concern pain severity, physical and emotional function and include a pain-intensity rating, a pain classification and questions related to the temporal pattern of pain for each specific pain problem. The impact of pain on physical, social and emotional function, and sleep is evaluated for each pain.

Pain intensity, pain interference and characteristics of spinal cord injury.

STUDY DESIGN: Postal survey. OBJECTIVES: To examine if the intensity of pain in persons with spinal cord injury (SCI) varied as a function of pain site, and to identify the patient and SCI characteristics associated with pain location, pain intensity and pain interference in a sample of persons with SCI. SETTING: Community sample, United States. METHODS: A postal survey including measures of pain intensity, pain interference, other pain, demographic and medical characteristics was completed by 238 adults with SCI. RESULTS: Average pain intensity was moderate and pain was common across the body. Demographic and medical variables, including SCI level, were generally not associated with pain prevalence, intensity and interference. However, persons with higher level injuries were more likely to report upper extremity pain than persons with paraplegic injuries. The lower body was the location of the highest pain ratings. CONCLUSION: Persons with SCI tend to experience high pain intensity over multiple body locations. Lower body pain was as common as upper extremity pain, but tended to be more intense.

Phase 2 trial of sustained-release fampridine in chronic spinal cord injury.

STUDY DESIGN: Double-blind, randomized, placebo-controlled, parallel-group clinical trial. OBJECTIVE: Assess safety and efficacy of sustained-release fampridine in subjects with chronic spinal cord injury. SETTING: A total of 11 academic rehabilitation research centers in the United States. METHODS: A total of 91 subjects with motor-incomplete spinal cord injury (SCI), randomized to three arms: fampridine, sustained release, 25 mg b.i.d. (Group I), 40 mg b.i.d. (Group II), and placebo (Group III) for 8 weeks. OUTCOME MEASURES: Patient diary questionnaire, Ashworth score, American Spinal Cord Injury Association International Standards, International Index of Erectile Function, bladder and bowel management questionnaires, and Clinician and Subject Global Impressions (Clinician Global Impression of change, Subject Global Impression (SGI)). Safety was evaluated from adverse events, physical examinations, vital signs, electrocardiograms, and laboratory tests. RESULTS: In total, 78% of the subjects completed the study. More (13/30) discontinued from Group II than Group I (4/30) and Group III (3/31). The most frequent adverse events across groups were hypertonia, generalized spasm, insomnia, dizziness, asthenia, pain, constipation, and headache. One subject in Group II experienced a seizure. SGI changed significantly in favor of Group I (P=0.02). Subgroup analysis of subjects with baseline Ashworth scores >1 showed significant improvement in spasticity in Group I versus III (P=0.02). CONCLUSIONS: Group I showed significant improvement in SGI, and potential benefit on spasticity. The drug was well tolerated. Group II showed more adverse events and discontinuations.

Chronic pain in individuals with spinal cord injury: a survey and longitudinal study.

STUDY DESIGN: Cross-sectional and longitudinal postal survey. OBJECTIVES: To (1) compare the severity of pain in persons with spinal cord injury (SCI) to national norms, (2) examine the association between pain and measures of (a) psychological functioning, (b) community integration and (c) pain interference with daily activities, and (3) examine the change in the prevalence and intensity of pain over time. SETTING: Community. METHODS: A total of 147 adults with SCI were surveyed twice, 2-6 years apart. Main outcome measures included presence/absence of pain in general and at specific body sites, 0-10 numerical rating scale of average pain intensity, modified Brief Pain Inventory Pain Interference scale, SF-36 Bodily Pain scale, SF-36 Mental Health scale, Community Integration Questionnaire. RESULTS: Pain was more severe, on average, in this sample of patients with SCI than it is in normative samples. The presence of pain was associated with trends towards poorer psychological functioning and social integration, and the intensity of pain was associated with interference with a number of important basic activities of daily living. Little systematic change was found in pain over a 2-6-year-period, although there was evidence that the prevalence of shoulder pain increases over time. CONCLUSION: The current findings underscore the serious nature of pain in persons with SCI and provide additional support for the need to identify effective treatments for SCI-related pain.

A bibliography of cost-effectiveness practices in physical medicine and rehabilitation: AAPM&R white paper.

Cost-effectiveness studies attempt to determine the ratio of costs to outcomes of a particular intervention or treatment and to compare a standard intervention with an alternative intervention to determine if the alternative is more cost effective. The goal is to establish priorities for the resources allocation and to decide among alternative interventions for the same medical condition. The global process of rehabilitation does not usually lend itself to cost-effective analysis (due to the complex set of treatments provided) but rather to specific interventions and specific aspects of outcome. The American Academy of Physical Medicine and Rehabilitation has published a cost effectiveness annotated bibliography on the Internet (http://www.aapmr.org/memphys/cebfinala.htm) that identifies 132 studies in the literature that meet specified criteria and are related to the field of rehabilitation. This White Paper attempts to interpret and synthesize the studies in that bibliography that relate to stroke, spinal cord injury (SCI), orthopedic conditions, pain syndromes, amputations, and traumatic brain injury (TBI). Most studies support the cost effectiveness of care for stroke and SCI in dedicated units or centers rather than in a general medical unit. Studies also support back programs and revascularization procedures in limb ischemia. Studies in TBI underscore the significant financial resources for the care of these patients as well as the potential benefit from rehabilitation services even in the most severely injured. Further high quality research in this area is needed.

Chronic pain associated with spinal cord injuries: a community survey.

OBJECTIVE: To investigate, in a community sample of people with spinal cord injuries (SCIs), chronic pain prevalence, associated factors, sites, characteristics, interference with daily functioning, treatments received, and treatment helpfulness. DESIGN: Postal survey. SETTING: Community. PARTICIPANTS: Three hundred eighty-four individuals aged over 17 years with SCIs. MAIN OUTCOME MEASURES: Chronic Pain Grade questionnaire, Short-Form McGill Pain Questionnaire, pain sites, and treatments. RESULTS: Current pain was reported by 79% of respondents and was significantly more common in less highly educated persons, and individuals not employed or in school. Most common locations of current pain were the back (61%), hips and buttocks (61%), and legs and feet (58%). Upper extremity pain was experienced by 76% after the injury and by 69% currently. Individuals with tetraplegia were significantly more likely to have neck and shoulder pain than were those with paraplegia. On average, respondents reported a high level of pain intensity and a moderate level of pain interference with activities, and rated treatments received for pain as being only somewhat helpful. CONCLUSION: Most individuals with SCI experience chronic pain that is refractory to medical treatment. Further research is needed to delineate the causes of, and optimal treatments for, the various pain problems in this population.

Women in physical medicine and rehabilitation. Leadership issues.

Academic medical centers share the triple missions of education, research, and clinical care, particularly in vulnerable populations. They are well positioned to have a significant impact on reducing health disparities between patients from diverse backgrounds, both now and in future generations. A key component to realizing this goal lies in increasing the number of women in academic medicine. Women bring a fresh perspective to the investigative process, often targeting gender is a better way of providing preventive services, and patient satisfaction studies have shown that many patients prefer women physicians.

Bladder management in women with neurologic disabilities.

Women with neurologic disabilities can experience an array of bladder disorders. There are many aspects of lower urinary tract management that are specific to women. Treatments should be based on urodynamic findings, and individualized for each woman's physical and cognitive abilities.

Long-term medical complications after traumatic spinal cord injury: a regional model systems analysis.

OBJECTIVE: To analyze the incidence, risk factors, and trends of long-term secondary medical complications in individuals with traumatic spinal cord injury. DESIGN: Data were reviewed from the National SCI Statistical Center on annual evaluations performed at 1, 2, 5, 10, 15, and 20 years after injury on patients injured between 1973 and 1998. SETTING: Multicenter Regional SCI Model Systems. MAIN OUTCOME MEASURES: Secondary medical complications at annual follow-up years, including pneumonia/atelectasis, autonomic dysreflexia, deep venous thrombosis, pulmonary embolism, pressure ulcers, fractures, and renal calculi. RESULTS: Pressure ulcers were the most frequent secondary medical complications in all years, and individuals at significant (p < .05) risk included those with complete injuries (years 1, 2, 5, 10), younger age (year 2), concomitant pneumonia/atelectasis (year 1, 2, 5), and violent injury (years 1, 2, 5, 10). The incidence of pneumonia/atelectasis was 3.4% between rehabilitation discharge and year-1 follow-up with those most significantly at risk being older than 60 years (years 1, 2, 5, 10) and tetraplegia-complete (years 1, 2). One-year incidence of deep venous thrombosis was 2.1% with a significant decline seen at year 2 (1.2%), and individuals most significantly (p < .001) at risk were those with complete injuries (year 1). The incidence of calculi (kidney and/or ureter) was 1.5% at 1-year follow-up and 1.9% at 5 years and was more frequent in patients with complete tetraplegia. Intermittent catheterization was the most common method of bladder management among patients with paraplegia but became less common at later postinjury visits. CONCLUSIONS: Pressure ulcers, autonomic dysreflexia, and pneumonia/atelectasis were the most common long-term secondary medical complications found at annual follow-ups. Risk factors included complete injury, tetraplegia, older age, concomitant illness, and violent injury.

Immobilization hypercalcemia treatment with pamidronate disodium after spinal cord injury.

OBJECTIVE: To review the use of pamidronate to treat immobilization hypercalcemia after acute spinal cord injury (SCI) in 9 cases. DESIGN: Retrospective case series. SETTING: Two inpatient rehabilitation programs, one pediatric and one adult, in the Northwest Regional Spinal Cord Injury System. PATIENTS: Patients with acute SCI who developed immobilization hypercalcemia that was treated with pamidronate. RESULTS: Nine patients (7 men, 2 women), ages 15 to 41 yrs, with SCI (8 tetraplegia, 1 paraplegia) were treated using pamidronate between 1994 and 1998. A single dose of 60 mg of pamidronate resolved the hypercalcemia or its symptoms in 7 (78%) patients within days. One patient required a second dose (90 mg) and one patient required three additional doses (the fourth at 90 mg) to achieve resolution of the hypercalcemia or symptoms. Side effects were mild and included drug-related fever in one patient and transient asymptomatic hypocalcemia in four patients. CONCLUSION: Pamidronate was effective in treating immobilization hypercalcemia caused by SCI. Its advantages include its effectiveness, the duration of treatment, ease of administration, and elimination of the need for long-term intravenous saline or daily medications.

Chronic pain problems in individuals with spinal cord injuries.

Chronic pain problems are common in individuals with spinal cord injuries (SCI); however, many questions about the prevalence, nature, and impact of such problems remain unanswered. Questionnaires were mailed to individuals on an SCI newsletter mailing list to investigate chronic pain problem prevalence, sites, characteristics, interference with daily functioning, associated factors, treatments received, and treatment helpfulness. Completed questionnaires were received from 164 individuals over age 17 with SCI. Unpleasant, but not painful, sensations were currently experienced by 75%, and 80.5% reported currently experiencing one or more pain problems. Among all 164 respondents, 62% reported experiencing high intensity pain in the previous week. Respondents indicated that they had received a variety of treatments for pain, but the only treatment reported to be helpful on average for the sample was opiate medication. Among respondents reporting current pain problems, most reported more than one problem (16.7% reported one, 25.8% reported two, 16.7% reported three, and 40.9% reported more than three). These findings indicate that chronic pain is a serious secondary problem in individuals with SCI and underscore the need for further research aimed at delineating the causes of, and optimal treatments for, the various pain problems in this population.

Upper extremity pain after spinal cord injury.

OBJECTIVE: Patients with spinal cord injury (SCI) may complain of upper extremity (UE) pain. The purpose of this study was to determine the frequency and severity of UE pain as well as its association with functional activities. Types of treatments that SCI patients received for UE pain and the benefits of these treatments were also identified. STUDY DESIGN AND METHODS: A questionnaire of demographic variables and measures of UE pain intensity, location, treatment, and interference with functional activities was mailed to 170 persons with SCI. Data was analyzed by descriptive and comparative statistics. RESULTS: Of the 130 persons who responded, 76 (58.5%) (38 paraplegic, 38 tetraplegic patients) reported UE pain: 71% had shoulder pain, 53% wrist pain, 43% hand pain, and 35% elbow pain. Pain interfered with transfers in 65% (36/55) of the patients who were doing them. Of ten functional activities, pain was more likely to be associated with pressure reliefs, transfers, and wheelchair mobility. Sixty-three per cent sought medical treatment for pain, and of those, 90% received either physical therapy, pharmacological treatment or massage. Although only 27% had wheelchair or home modification or joint protection education, these approaches were helpful for almost all and very helpful or extremely helpful in 26.6% and 63.6% of the patients, respectively. CONCLUSION: UE pain is a common problem in individuals with SCI and has impact on daily activities. UE pain prevention and management programs are needed for SCI patients.

Management of focal dystonia of the extensor hallucis longus muscle with botulinum toxin injection: a case report.

Recently botulinum toxin has been used with increasing frequency as a safe and effective treatment for many previously refractory conditions associated with excessive muscle activity. The indications for use of botulinum toxin injection continue to expand. This report describes the case of an 83-year-old woman with a history of diabetes mellitus and lumbar spinal stenosis who developed a severe focal dystonia of the left great toe, such that the toe maintained the extended position. Functionally, the resultant deformity prevented the patient from wearing shoes. In addition, the patient had significant pain in the left great toe. Under needle electromyographic localization, 50 units of botulinum toxin were injected into the left extensor hallucis longus muscle. Two weeks after the injection the patient was symptom free and could place her left foot into a shoe. Seven months later, she remained symptom free. This case illustrates that localized injection of botulinum toxin to a specific lower limb muscle can effectively result in decreased muscle activity and functional improvement.