Sally Ann Holmes

Comparison of dalteparin and enoxaparin for deep venous thrombosis prophylaxis in patients with spinal cord injury

Chiou-Tan FY, Garza H, Chan KT, Parsons KC, Donovan WH, Robertson CS, Holmes SA, Graves DE, Rintala DH: Comparison of dalteparin and enoxaparin for deep venous thrombosis prophylaxis in patients with spinal cord injury. Am J Phys Med Rehabil 2003;82:678–685. Objective To determine differences between dalteparin and enoxaparin in patients with spinal cord injury. Design This prospective, randomized, open-label study was performed as a multiple hospital trial in a large urban setting. A total of 100 patients with acute (<3 mo) spinal cord injury were recruited. A total of 95 patients met all inclusion criteria. Fifty received enoxaparin, and 45 received dalteparin. Main outcome measures included deep venous thrombosis, bleeding, compliance, Short Form-12 Health Status Survey, satisfaction, and medication/labor costs. Patients were randomized to receive 30 mg of enoxaparin subcutaneously every 12 hr or 5000 IU of dalteparin subcutaneously once daily. Prophylaxis was continued for 3 mo for motor-complete and 2 mo for motor-incomplete patients. Results Six percent of the patients developed deep venous thrombosis while receiving enoxaparin and 4% while receiving dalteparin (&khgr;2 = 0.44, df = 1, P = 0.51). Four percent developed bleeding while receiving dalteparin and 2% while receiving enoxaparin (&khgr;2 = 0.13, df = 1, P = 0.72). No differences were noted in compliance, health status, or most of the satisfaction measures. It was, however, noted that after being discharged home, the patients receiving enoxaparin rated the shots significantly more inconvenient (two injections per day) compared with taking three pills per day, than those receiving dalteparin (one injection per day, P < 0.05). The cost of the medication was

Predictors of pressure ulcer recurrence in veterans with spinal cord injury.

1101/mo for enoxaparin (two injections per day) and

Effectiveness of Supported Employment for Veterans With Spinal Cord Injuries: Results From a Randomized Multisite Study

750/mo for dalteparin (one injection per day). Conclusion Similar compliance, health status, deep venous thrombosis, and bleeding rates were found between dalteparin and enoxaparin.

Effect of Dronabinol on Central Neuropathic Pain After Spinal Cord Injury: A Pilot Study

Abstract Background/Objective: To predict recurrence of pressure ulcers (PrUs) in a high-risk populationofveterans with spinal cord injury (SCI). Design:Cross-sectional observational design. Participants: A convenience sample of 64 subjects from 6 Department of Veterans Affairs (VA) SCI Centers who had been admitted to the hospital for the treatment of stage III-IV pelvic PrUs and were healed at the time of discharge back to the community. Main Outcome Measures:Primary outcome measures were pelvic PrU recurrence, defined as selfreported new skin breakdown (stage II or greater) in the pelvic area (not necessarily in the same location as previous ulcer) and time to recurrence. Results:There were no differences between those with/without recurrences with regard to age, age at/level of injury, number of previous ulcers or surgery, rate of or time, to recurrence. Mean age was 56 years; most were white and men, lived at home, and had some college education. Mean time since SCI was 22 years; 28% had tetraplegia; mean number of prior pressure ulcers was 3; and almost one half had a previous ulcer in the same location. The strongest predictor of recurrence in a multivariate logistic regression was African American race (odds ratio = 9.3). Additional predictors included higher scores on the Charlson Co-Morbidity Index (indicating a higher burden of illness), the Salzburg PrU Risk Assessment Scales, and longer sitting time at discharge. Conclusion:Identifying individuals at highest risk for recurrence and developing effective prevention programs are essential rehabilitation goals. We recommend that the unique findings of this exploratory study be considered preliminary until replication of these results is published.

Differential responses to measures of gait performance among healthy and neurologically impaired individuals

OBJECTIVE To examine whether supported employment (SE) is more effective than treatment as usual (TAU) in returning veterans to competitive employment after spinal cord injury (SCI). DESIGN Prospective, randomized, controlled, multisite trial of SE versus TAU for vocational issues with 12 months of follow-up data. SETTING SCI centers in the Veterans Health Administration. PARTICIPANTS Subjects (N=201) were enrolled and completed baseline interviews. In interventional sites, subjects were randomly assigned to the SE condition (n=81) or the TAU condition (treatment as usual-interventional site [TAU-IS], n=76). In observational sites where the SE program was not available, 44 subjects were enrolled in a nonrandomized TAU condition (treatment as usual-observational site [TAU-OS]). INTERVENTIONS The intervention consisted of an SE vocational rehabilitation program called the Spinal Cord Injury Vocational Integration Program, which adhered as closely as possible to principles of SE as developed and described in the individual placement and support model of SE for persons with mental illness. MAIN OUTCOME MEASURES The primary study outcome measurement was competitive employment in the community. RESULTS Subjects in the SE group were 2.5 times more likely than the TAU-IS group and 11.4 times more likely than the TAU-OS group to obtain competitive employment. CONCLUSIONS To the best of our knowledge, this is the first and only controlled study of a specific vocational rehabilitation program to report improved employment outcomes for persons with SCI. SE, a well-prescribed method of integrated vocational care, was superior to usual practices in improving employment outcomes for veterans with SCI.

Neurophysiological assessment of lower-limb voluntary control in incomplete spinal cord injury

Rintala DH, Fiess RN, Tan G, Holmes SA, Bruel BM: Effect of dronabinol on central neuropathic pain after spinal cord injury: A pilot study. Objective:To test the efficacy and safety of a cannabinoid, dronabinol, compared with an active control, diphenhydramine, in relieving neuropathic pain in persons with spinal cord injury. Design:A randomized, controlled, double-blind, crossover pilot study. Results:Seven adults with spinal cord injury and neuropathic pain below the level of injury participated. Two participants withdrew while receiving dronabinol, their first medication. For the remaining five participants, change in pain on a scale of 0–10 from baseline to the end of the maintenance phase did not differ significantly between the two medications (mean change, dronabinol: 0.20 ± 0.837, range = −1.00 to 1.00; diphenhydramine: −1.80 ± 2.490, range = −6.00 to 0; Wilcoxon Z = 1.63, P = 0.102). Similar results were found when the average of the two ratings during the maintenance phase was used (dronabinol: −0.20 ± 0.671, range = −0.50 to 1.00; diphenhydramine: −1.40 ± 1.245, range = −3.50 to −0.50; Wilcoxon Z = 1.60, P = 0.109). The most common side effects were dry mouth, constipation, fatigue, and drowsiness for both medications. Conclusions:On average, dronabinol was no more effective than diphenhydramine for relieving chronic neuropathic pain below the level of injury.

Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase

OBJECTIVES To compare gait during a 5-minute walk among healthy individuals, persons with spinal cord injury (SCI), and stroke survivors and to investigate whether simultaneous measures of oxygen consumption enhance information about performance. DESIGN Descriptive study. SETTING Veterans Affairs medical center. PARTICIPANTS Thirty-nine healthy individuals, 10 persons with SCI, and 20 stroke survivors. INTERVENTIONS Participants were fitted with a portable gas analyzer and walked on a 5-m walkway for 5 minutes. MAIN OUTCOME MEASURES Measures of walk distance, gait speed, gait energy expenditure (GEE), and gait cost were obtained, along with measures of ventilation (.Ve), ventilation and carbon dioxide production slope (.Ve . .VCo2), oxygen pulse, and heart rate. RESULTS The SCI group (127.65+/-81.74m) walked less than the stroke survivors (148.80+/-64.3m) or the healthy group (268.90+/-35.01m) but had higher energy demands, as shown by GEE (SCI group, 13.28+/-3.23mL.kg(-1).min(-1); stroke group, 10.18+/-2.14mL.kg(-1).min(-1); healthy group, 9.61+/-1.90mL.kg(-1).min(-1)) and by gait cost (SCI group,.57+/-.40 mL.kg(-1).m(-1); stroke group,.40+/-.52mL.kg(-1).m(-1); healthy group,.18+/-.02mL.kg(-1).m(-1)). Compared with the healthy group, the stroke group had higher .Ve (stroke group, 22.34+/-5.20L/min vs healthy group, 16.11+/-3.22L/min) and .Ve . .VCo2 slope (24.22+/-8.80 vs 18.73+/-5.44, respectively). CONCLUSION Use of metabolic assessment during the 5-minute walk was feasible and provided further information for evaluating gait performance with the subjects studied.

Neurophysiological examination of the corticospinal system and voluntary motor control in motor-incomplete human spinal cord injury

Study design:Cross-sectional retrospective study of a neurophysiological method of voluntary motor control characterization.Objectives:This study was undertaken to validate the surface electromyography (sEMG)-based voluntary response index (VRI) as an objective, quantitative, laboratory measure of spinal cord injury severity in terms of voluntary motor control disruption.Setting:VA Medical Centers in Houston and Dallas Texas, USA.Methods:A total of 67 subjects with incomplete spinal cord injury (iSCI), American Spinal Injury Association Impairment Scale (AIS)-C (n=32) and -D (n=35) were studied. sEMG recorded during a standardized protocol including eight lower-limb voluntary motor tasks was analyzed using the VRI method that relates multi-muscle activation patterns of SCI persons to those of healthy-subject prototypes (n=15). The VRI is composed of a measure of the amount of the sEMG activity (magnitude) and the distribution of activity across muscle groups compared to that of healthy subjects for each motor task (similarity index, SI). These resulting VRI components, normalized magnitude and SI, were compared to AIS clinical findings in this study. Receiver operating characteristic analysis was performed to determine the SI values best separating AIS-C and AIS-D subjects.Results:Magnitude and SI for AIS-C subjects had mean values of 0.27±0.32 and 0.65±0.21, respectively. Both parameters were significantly larger in the AIS-D subjects (0.78±0.43 and 0.93±0.06), respectively (P<0.01). An SI value of 0.85 was found to separate AIS-C and AIS-D groups with a sensitivity of 0.89 and a specificity of 0.81. Further, the VRI of each leg strongly correlated with the respective AIS motor score (0.80, r<0.01).Conclusions:In the domains of voluntary motor control, the sEMG-based VRI demonstrated adequate face validity and sensitivity to injury severity as currently measured by the AIS.Sponsorship:Veterans Affairs Medical Center.

Analysis of sEMG during voluntary movement-part II: voluntary response index sensitivity

Abstract Background Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. Objective Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Study design Multi-site, double-blind, sham-controlled study. Participants Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. Intervention Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess ‘as-needed’ CES use. Outcome measures Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. Results The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal–Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). Conclusions On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief.

Comparing multicomponent interventions to improve skin care behaviors and prevent recurrence in veterans hospitalized for severe pressure ulcers

This study employed neurophysiological methods to relate the condition of the corticospinal system with the voluntary control of lower-limb muscles in persons with motor-incomplete spinal cord injury. It consisted of two phases. In a group of ten healthy subjects, single and paired transcranial magnetic stimulation (TMS) of the motor cortex was used to study the behavior of the resulting motor evoked potentials (MEP) in lower-limb muscles. Interstimulus intervals (ISIs) of 15–100 ms were examined for augmentation of test MEPs by threshold or subthreshold conditioning stimuli. The second phase of this study examined eight incomplete spinal cord injured (iSCI) subjects, American Spinal Injury Association Impairment Scale C (n =5) and D (n =3) in whom voluntary motor control was quantified using the surface EMG (sEMG) based Voluntary Response Index (VRI). The VRI is calculated to characterize relative output patterns across ten lower-limb muscles recorded during a standard protocol of elementary voluntary motor tasks. VRI components were calculated by comparing the distribution of sEMG in iSCI subjects with prototype patterns collected from 15 healthy subjects using the same rigidly administered protocol, The resulting similarity index (SI) and magnitude values provided the measure of voluntary motor control. Corticospinal system connections were characterized by the thresholds for MEPs in key muscles. Key muscles were those that function as the prime-movers, or agonists for the voluntary movements from which the VRI data were calculated. Results include healthy-subject data that showed significant increases in conditioned MEP responses with paired stimuli of 15–50 ms ISI. Stimulus pairs of 75 and 100 ms showed no increase in MEP peak amplitude over that of the single-pulse conditioning stimulus alone, usually no response. For the iSCI subjects, 42% of the agonists responded to single-pulse TMS and 25% required paired-pulse TMS to produce an MEP. American Spinal Injury Association Impairment Scale component motor scores for agonist muscles, Quadriceps, Tibialis Anterior, and Triceps Surae, were significantly lower where MEPs could not be obtained (p <0.05). VRI values were also significantly lower for motor tasks with agonists that had no resting MEP (p <0.01). Therefore, the presence of a demonstrable connection between the motor cortex and spinal motor neurons in persons with SCI was related to the quality of post-injury voluntary motor control as assessed by the VRI.