T.K. Murphy

Pregabalin for painful HIV neuropathy: a randomized, double-blind, placebo-controlled trial.

Objective: Pregabalin is effective in several neuropathic pain syndromes. This trial evaluated its efficacy, safety, and tolerability for treatment of painful HIV-associated neuropathy. Methods: This randomized, double-blind, placebo-controlled, parallel-group trial included a 2-week double-blind dose-adjustment (150–600 mg/day BID) phase, a 12-week double-blind maintenance phase, and an optional 3-month open label extension phase. The primary efficacy measure was the mean Numeric Pain Rating Scale (NPRS) score, an 11-point numeric rating scale. Secondary measures included Patient Global Impression of Change (PGIC) and sleep measurements. Results: Baseline mean NPRS score was 6.93 for patients randomized to pregabalin (n = 151) and 6.72 for those to placebo (n = 151). Pregabalin average daily dosage (SD) was 385.7 (160.3) mg/d. At endpoint, pregabalin and placebo showed substantial reductions in mean NPRS score from baseline: −2.88 vs −2.63, p = 0.3941. Pregabalin had greater improvements in NPRS score relative to placebo at weeks 1 (−1.14 vs −0.69, p = 0.0131) and 2 (−1.92 vs −1.43, p = 0.0393), and at weeks 7 (−3.22 vs −2.53 p = 0.0307) and 8 (−3.33 vs −2.53, p = 0.0156). At all other time points, differences between groups were not significant. Sleep measurements and 7-item PGIC did not differ among treatment groups; however, collapsed PGIC scores showed 82.8% of pregabalin and 66.7% of placebo patients rated themselves in 1 of the 3 “improved” categories (p = 0.0077). Somnolence and dizziness were the most common adverse events with pregabalin. Conclusions: Pregabalin was well-tolerated, but not superior to placebo in the treatment of painful HIV neuropathy. Factors predicting analgesic response in HIV neuropathy warrant additional research. Classification of Evidence: This Class II trial showed that pregabalin is not more effective than placebo in treatment of painful HIV neuropathy.

Pregabalin in the treatment of post-traumatic peripheral neuropathic pain: a randomized double-blind trial.

Background:  Pregabalin is effective in the treatment of peripheral and central neuropathic pain. This study evaluated pregabalin in the treatment of post‐traumatic peripheral neuropathic pain (including post‐surgical).

290 EFFICACY AND SAFETY OF PREGABALIN AS TREATMENT OF PAINFUL DIABETIC PERIPHERAL NEUROPATHY (DPN): A 13‐WEEK RANDOMIZED CONTROLLED TRIAL AND 6‐MONTH SAFETY EXTENSION

amputation, reason and area of amputation, intensity and appeased factors of phantom pain, amount and kind of medication for relive phantom pain and severity of pain was determined and controlled with MC GILL visual Analogue scale before and after acupressure findings were statistically by using SPSS software. Results. Analyzing statistical tests, indicates that acupressure treatment can decrease intensity of phantom pain (p < 0.0001) and decrease amount of medications (p < 0.005) and both of hypothesis were accepted.

448 PREDICTORS OF PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) RESPONSE IN PERIPHERAL NEUROPATHIC PAIN: RESULTS FROM 10 TRIALS WITH PREGABALIN

Background and Aims: Complex Regional Pain Syndrome (CRPS) develops in a significant number of stroke individuals and interferes with rehabilitation process and delays recovery of the upper limb function. We suggested that determination of the frequency of CRPS in stroke patients may concentrate attention on this problem and the evaluation of distribution and intensity of pain in the involved limb would be helpful in appropriate and effective treatment of CRPS in this patient group. Methods: Forty consecutive inpatient stroke individuals hospitalized for rehabilitation (mean age: 65.6±10.1 years, mean interval between the stroke and the examination: 35.6±73.1 weeks, 15 male, 25 female, 33 ischemic and 7 hemorrhagic stroke) were investigated prospectively. Patients were diagnosed as CRPS according to IASP diagnostic criteria for complex regional pain syndrome. Pain intensity was determined in shoulder, elbow, wrist and fingers of the involved limb by using the method by which Ritchie articular index is calculated. Descriptive statistics, Friedman Test and Wilcoxon Test were used in statistical analysis. Results: Ten of 40 patients (25%) had CRPS. Mean pain scores were 1.80±1.03, 1.00±0.67, 2.50±0.71, 2.40±0.52 for shoulder, elbow, wrist and fingers respectively and there were statistically significant difference among them (p = 0.001). Pain intensity was significantly lower in elbow when compared with shoulder (p< 0.05), wrist (p< 0.01) and fingers (p< 0.01). There were no statistically significant difference among shoulder, wrist and finger scores. Conclusions: According to our results 25% of stroke patients develops CRPS. Patients experience more intense pain in hand and shoulder than elbow region.

304 Efficacy, by baseline severity of anxiety symptoms, of pregabalin for treating central neuropathic pain in patients with spinal cord injury (SCI)

and thermal discrimination was affected regardless of the manifestation of CPSP. However, it was found that heat and cold pain thresholds were more severely affected in the pain group as was the mean side-to-side differences of tactile sensibility. Further correlations indicated that hyperpathia generally coexisted with allodynia and was exclusive to the pain group. These results provide a baseline for the exploration of new methods to predict, assess and treat central neuropathic pain from stroke.

258 A DOUBLE‐BLIND, RANDOMIZED, PLACEBO‐CONTROLLED TRIAL TO EVALUATE TIME‐TO‐ONSET OF CLINICALLY MEANINGFUL PAIN RELIEF IN POSTHERPETIC NEURALGIA (PHN) PATIENTS TREATED WITH PREGABALIN

258 A DOUBLE-BLIND, RANDOMIZED, PLACEBOCONTROLLED TRIAL TO EVALUATE TIME-TOONSET OF CLINICALLY MEANINGFUL PAIN RELIEF IN POSTHERPETIC NEURALGIA (PHN) PATIENTS TREATED WITH PREGABALIN M.C. Rowbotham , B.R. Stacey , K. Phillips , E. Whalen , T.K. Murphy , J.A. Barrett * a UCSF Pain Clinical Research Center, San Francisco, CA,USA b Oregon Health & Science University, Portland, OR, USA c Pfizer, Inc., New York, USA

449 ONSET AND DURATION OF ANALGESIA IN COMBINED ANALYSES OF CLINICAL TRIALS OF PREGABALIN FOR PAINFUL DPN AND PHN

Background and Aims: Complex Regional Pain Syndrome (CRPS) develops in a significant number of stroke individuals and interferes with rehabilitation process and delays recovery of the upper limb function. We suggested that determination of the frequency of CRPS in stroke patients may concentrate attention on this problem and the evaluation of distribution and intensity of pain in the involved limb would be helpful in appropriate and effective treatment of CRPS in this patient group. Methods: Forty consecutive inpatient stroke individuals hospitalized for rehabilitation (mean age: 65.6±10.1 years, mean interval between the stroke and the examination: 35.6±73.1 weeks, 15 male, 25 female, 33 ischemic and 7 hemorrhagic stroke) were investigated prospectively. Patients were diagnosed as CRPS according to IASP diagnostic criteria for complex regional pain syndrome. Pain intensity was determined in shoulder, elbow, wrist and fingers of the involved limb by using the method by which Ritchie articular index is calculated. Descriptive statistics, Friedman Test and Wilcoxon Test were used in statistical analysis. Results: Ten of 40 patients (25%) had CRPS. Mean pain scores were 1.80±1.03, 1.00±0.67, 2.50±0.71, 2.40±0.52 for shoulder, elbow, wrist and fingers respectively and there were statistically significant difference among them (p = 0.001). Pain intensity was significantly lower in elbow when compared with shoulder (p< 0.05), wrist (p< 0.01) and fingers (p< 0.01). There were no statistically significant difference among shoulder, wrist and finger scores. Conclusions: According to our results 25% of stroke patients develops CRPS. Patients experience more intense pain in hand and shoulder than elbow region.

468 PROFILE OF SLEEP EFFECTS OF PREGABALIN IN PATIENTS WITH CHRONIC PAIN SYNDROMES AND IN HEALTHY VOLUNTEERS

Background & aims: Complex regional pain syndrome (CRPS) is associated with reduced tactile acuity. Tactile acuity is increased when visual and tactile input are available (cross-modal interaction). We hypothesised: tactile discrimination training (TDT) increases tactile acuity in CRPS patients; that the effect is enhanced by cross-modal interaction. Methods: Experiment 1: After a WAITING period, seventeen CRPS patients underwent daily sessions of tactile stimulation (light pressure, two probes of different width, five locations, limb hidden from view). For the first two weeks, stimulation was passive – no response was required from patients (SHAM). For the next two weeks, stimuli were identical, but patients reported the type of probe and the location of each stimulus (TDT). Experiment 2: Ten CRPS patients underwent TDT with three types of visual input: watching the reflected opposite limb, watching the opposite limb, looking in the direction of the (hidden) affected limb. Results: Experiment 1: Pain, disability and two-point discrimination (TPD) were unaffected during WAITING and SHAM, but decreased during TDT (p< 0.01), maintained at three months. Decrease in pain related to decrease in TPD (r = 0.627, p = 0.016). Experiment 2: TPD decreased in each condition. The largest decrease occurred when patients watched the reflected opposite limb during TDT. Decrease in TPD related to decrease in resting pain (r = 0.63, p< 0.001). Conclusions: TDT decreases pain and disability and increases tactile acuity in CRPS patients. The effect is enhanced by utilising cross-modal interaction between vision and touch. Changes in pain and tactile acuity are related.

769 PRESENCE OF COMORBID ANXIETY SYMPTOMS DOES NOT COMPROMISE THE EFFICACY OF PREGABALIN FOR TREATING CENTRAL NEUROPATHIC PAIN

4 days. Other complications such as somnolence, ataxia, light-headedness, dizziness and visual disturbances were also followed. VAS scores were significantly lower in group 1 than in group 2 for 4 days. Oral gabapentine administration in patients occurred PDPH after spinal anaesthesia is an effective and safe a treatment. The oral administration of gabapentin has provided a significant analgesic benefit for postdural puncture headache relief in patients.