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 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.

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.

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.

Risks associated with pregnancy in spinal cord-injured women.

We reviewed the experience with pregnancy in spinal cord-injured women at the University of Washington over the past 10 years. During that time, 11 women with spinal cord injury had 13 pregnancies. Infant outcome was uniformly good. No major obstetric complication occurred. The mothers experienced medical problems including urinary tract infection in ten and pyelonephritis in three. Autonomic hyperreflexia occurred in three of five subjects with lesions at or above the sixth thoracic vertebra. Pregnancy in the spinal cord-injured patient involves medical risk for the mother, but with careful management, an excellent outcome for both mother and infant may be anticipated.

Effectiveness of behavioral therapy for chronic low back pain: a component analysis.

The effects of outpatient group behavioral therapy including aerobic exercise (BE), behavioral therapy only (B), and aerobic exercise only (E) on pain and physical and psychosocial disability were evaluated and compared in a group of mildly disabled chronic low-back-pain patients. Ninety-six Ss were randomly assigned to the 3 treatments and a waiting-list control (WL) condition and assessed on a variety of patient self-report, spouse-rated, and direct observational measures at pretreatment, posttreatment, and 6- and 12-month follow-ups. Patients in the BE condition, but not the B or E conditions, improved significantly more pretreatment to posttreatment than did WL patients on the patient self-report and observer-rated measures. At both follow-ups, all 3 treatment groups remained significantly improved from pretreatment, with no significant differences among treatments.

Cognitive psychopharmacology.

This article examines the use of compounds classified as "cognitive activators" to treat cognitive deficits from neurologic disorders, particularly brain injury. The compounds reviewed include catecholamine agonists, cholinergic agonists, nootropics, gangliosides, and thyrotropin releasing hormone (TRH). We present both our own work and the work of other investigators who have studied the effects of these drugs on cognitive-behavioral functioning. A major emphasis of this article is the examination of different types of approaches to assess the treatment efficacy of drug interventions. The different approaches discussed include physiological, psychometric, and behavioral measures. Recommendations of specific measures that have been shown to be especially sensitive to treatment effects are provided.

Reducing the period of immobilization following pressure sore surgery: a prospective, randomized trial.

The cost to care for a patient with pressure sores can be exorbitant. One part of this expense results from the prolonged postoperative immobilization. Published protocols report 3 to 8 weeks of immobilization; however, there are no studies that establish longer periods to be superior. To justify our 3-week protocol, we conducted a prospective, randomized trial of 2 versus 3 weeks of postoperative immobilization. Each patient was randomized preoperatively to either 2 or 3 weeks of postoperative immobilization. A total of 42 patients with a diagnosis of paraplegia, tetraplegia, or multiple sclerosis and a solitary pressure sore were enrolled over 5 years. The complication rates in the two groups (9 of 23, or 39 percent, for the 2-week group and 9 of 19, or 47 percent, for the 3-week group) were not statistically different (p < 0.493). However, the time to mobilization was significantly reduced in the 2-week group (16.1 +/- 6.1 versus 22.9 +/- 4.9 days, p < 0.0003), as was the time to achieve sitting (21.2 versus 28.9 days, p < 0.0026). In summary, 2 weeks of postoperative immobilization following surgery is adequate for uncomplicated solitary pressure sores.

Limb-salvage in reconstruction of recalcitrant pressure sores using the inferiorly based rectus abdominis myocutaneous flap.

Pressure sore closure is frequently a reconstructive challenge. This challenge is particularly evident in cases of multiply recurrent sores. In such settings, there are often opportunities to manage the recurrent wounds either by repeated advancement of previous flaps or by design of alternative ones. However, these interventions are not always feasible, and limb amputation with total thigh flap closure must be considered. A review of operative experience with seven such complex pressure sores in seven patients is presented. Each patient had previously suffered a permanent thoracic-level spinal cord injury. Prior attempts at wound closure were unsuccessful. Despite consideration of all described locoregional flaps, no limb-sparing procedure could be designed satisfactorily. As an alternative to either hip disarticulation and total thigh flap coverage or distant free-tissue transfer, we reconstructed the debrided ulcer beds with inferiorly based rectus abdominis myocutaneous flaps. Six of the seven wounds healed primarily, whereas one required repeated debridement and the addition of a gracilis muscle flap to achieve complete closure. Postoperative follow-up has ranged from 6 to 45 months. Each patient has returned to his baseline preoperative activity level with no clinical compromise of abdominal wall function. All wounds have healed. Successful application of the inferiorly based vertical rectus abdominis myocutaneous flap for cases of both recalcitrant ischial and trochanteric pressure sores is demonstrated and its consideration is advocated if no reconstructive options short of extremity amputation and total thigh flap coverage exist for such challenging sores.

Results of 268 pressure sores in 158 patients managed jointly by plastic surgery and rehabilitation medicine.

Despite improvements in surgical repair of pressure sores, recurrence rates greater than 80 percent are reported, thus indicating that this difficult problem is not yet solved. Recurrence results in additional hospitalizations and increased medical expenses. Because associated general clinical and social issues are numerous for these patients, our physical medicine and rehabilitation colleagues are active participants in their perioperative medical care. In addition, the Department of Physical Medicine and Rehabilitation also directs a complete postreconstruction rehabilitation and education program for them. The results of surgically repaired pressure sores for patients managed in this collaborative fashion have not been previously reported. Pressure sore patients at the Harborview and University of Washington Medical Centers are evaluated by plastic surgery colleagues together with the Department of Physical Medicine and Rehabilitation. Patients believed to be candidates for complete postoperative rehabilitation are offered surgical repair and constitute this study cohort. Individuals who cannot cooperate with our protocol are treated nonoperatively and are not included in this study. A retrospective analysis of all 158 patients (mean age 34.5 years) operated on for 268 grade III and IV pressure sores between October of 1977 and December of 1989 was performed. Following surgical debridement and reconstruction, patients receive their principal medical care from the Department of Physical Medicine and Rehabilitation service while the Plastic Surgery Department manages the surgical wounds. Graduated patient mobilization is initiated in accord with a mutually agreed upon standardized protocol. New or primary sores numbered 174 (65 percent), and recurrent or secondary sores numbered 94 (35 percent). Mean patient follow-up was 3.7 years. The overall pressure sore recurrence rate (recurrence at the same site) was 19 percent, and the overall patient recurrence rate (previous patient developing a new sore) was 25 percent. Recurrence rates of 22 and 15 percent were noted for primary and secondary pressure sores, respectively. On most recent examination, 131 patients (83 percent) had intact pelvic and perineal skin. These results support a collaborative approach to the management of high-grade pressure sore patients. Our protocol of mutual patient evaluation followed by surgical reconstruction and postoperative rehabilitation yields notably low recurrence rates of both primary and secondary sores. In addition, the high percentage of patients who manifest long-term maintenance of skin integrity demonstrates the excellent education in personal skin and self-care that this approach provides. Not only do patients enjoy successful and durable reconstructive results, but additional hospitalizations and health care expenses implicit to pressure sore recurrence are consequently diminished. This collaborative clinical effort remains our standard of care.

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.

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.

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.

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.

Dorsal nerve of the penis nerve conduction velocity: a new technique.

In the evaluation of a possible peripheral neuropathic process as the etiology of erectile dysfunction, studies of the dorsal nerve of the penis may be unique in that they allow examination of the most distal segment of pudendal nerve in isolation. This study describes a new technique using a simple traction device for elongation of the penis to determine the orthodromic nerve conduction of the dorsal nerve of the penis. With stimulation at the glans, and recording at the base of the penis, the value obtained in 20 normal subjects was 36.2 +/- 3.2 m/s with an amplitude of 2.29 +/- 1.08 mV.