I am a
Home I AM A Search Login

Human Studies

Share this

Design of Phase 3 Studies Evaluating Vixotrigine for Treatment of Trigeminal Neuralgia.

Vixotrigine (BIIB074) is a voltage- and use-dependent sodium channel blocker. These studies will evaluate the efficacy and safety of vixotrigine in treating pain experienced by patients with trigeminal neuralgia (TN) using enriched enrollment randomized withdrawal trial designs.

A Qualitative Evaluation of the Pain Management VA-ECHO Program Using the RE-AIM Framework: The Participant’s Perspective.

Veterans frequently seek chronic pain care from their primary care providers (PCPs) who may not be adequately trained to provide pain management. To address this issue the Veterans Health Administration (VHA) Office of Specialty Care adopted the Specialty Care Access Network Extension for Community Healthcare Outcomes (VA-ECHO née SCAN-ECHO). The VA-ECHO program offered training and mentoring by specialists to PCPs and their staff. VA-ECHO included virtual sessions where expertise was shared in two formats: (1) didactics on common pain conditions, relevant psychological disorders, and treatment options and (2) real-time consultation on patient cases. VA-ECHO participants' perspectives were obtained using a semi-structured interview guide designed to elicit responses based on the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. A convenience sampling was used to recruit PCPs and non-physician support staff participants. Non-physicians from rural VHA sites were purposively sampled to gain diverse perspectives. This qualitative study yielded data on each RE-AIM domain except reach. Program reach was not measured as it is outside the scope of this study. Respondents reported program effectiveness as gains in knowledge and skills to improve pain care delivery. Effective incorporation of learning into practice was reflected in respondents' perceptions of improvements in: patient engagement, evidenced-based approaches, appropriate referrals, and opioid use. Program adoption included how participating health care systems selected trainees from a range of sites and roles to achieve a wide reach of pain expertise. Participation was limited by time to attend and facilitated by institutional support. Differences and similarities were noted in implementation between hub sites. Maintenance was revealed when respondents noted the importance of the lasting relationships formed between fellow participants. This study highlights VA-ECHO program attributes and unintended consequences. These findings are expected to inform future use of VA-ECHO as a means to establish a supportive consultation network between primary and specialty care providers to promote the delivery evidence-based pain management practices.

Sex-Specific Impact of Pain Severity, Insomnia, and Psychosocial Factors on Disability due to Spinal Degenerative Disease.

Pain experience due to spinal degenerative disease decreases activity of daily living and quality of life. The present cross-sectional study was aimed at examining the sex-specific impact of pain severity, psychosocial factors, and insomnia on the disability due to chronic pain arising from spinal degenerative disease.

Psychosocial Underpinnings of Pain and Sleep Disturbance in Safety-Net Primary Care Patients.

The aim of this study was to uncover possible psychosocial underpinnings of pain and sleep disturbance in a safety-net primary care sample.

The Hausa 12-item short-form health survey (SF-12): Translation, cross-cultural adaptation and validation in mixed urban and rural Nigerian populations with chronic low back pain.

Measuring health-related quality of life (HRQOL) in patients with chronic low back pain (LBP) is crucial to monitor and improve the patients' health status through effective rehabilitation. While the 12-item short-form health survey (SF-12) was developed as a shorter alternative to the 36-item short-form health survey for assessing HRQOL in large-scale studies, to date, no cross-culturally adapted and validated Hausa version exists. This study aimed to translate and cross-culturally adapt the SF-12 into Hausa language, and test its psychometric properties in mixed urban and rural Nigerian populations with chronic LBP.

Baseline Brain Gray Matter Volume as a Predictor of Acupuncture Outcome in Treating Migraine.

The present study aimed to investigate the use of imaging biomarkers to predict the outcome of acupuncture in patients with migraine without aura (MwoA). Forty-one patients with MwoA received 4 weeks of acupuncture treatment and two brain imaging sessions at the Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University. Patients kept a headache diary for 4 weeks before treatment and during acupuncture treatment. Responders were defined as those with at least a 50% reduction in the number of migraine days. The machine learning method was used to distinguish responders from non-responders based on pre-treatment brain gray matter (GM) volume. Longitudinal changes in GM predictive regions were also analyzed. After 4 weeks of acupuncture, 19 patients were classified as responders. Based on 10-fold cross-validation for the selection of GM features, the linear support vector machine produced a classification model with 73% sensitivity, 85% specificity, and 83% accuracy. The area under the receiver operating characteristic curve was 0.7871. This classification model included 10 GM areas that were mainly distributed in the frontal, temporal, parietal, precuneus, and cuneus gyri. The reduction in the number of migraine days was correlated with baseline GM volume in the cuneus, parietal, and frontal gyri in all patients. Moreover, the left cuneus showed a longitudinal increase in GM volume in responders. The results suggest that pre-treatment brain structure could be a novel predictor of the outcome of acupuncture in the treatment of MwoA. Imaging features could be a useful tool for the prediction of acupuncture efficacy, which would enable the development of a personalized medicine strategy.

Allodynography: Reliability of a New Procedure for Objective Clinical Examination of Static Mechanical Allodynia.

There is a need for reliable and valid clinical assessment tools for quantifying allodynia in neuropathic pain. Allodynography has been proposed as a useful standardized procedure for clinical assessment of mechanical allodynia. This study (www.clinicaltrials.gov NCT02070367) undertook preliminary investigation of the measurement properties of allodynography, a new standardized clinical examination procedure for mapping the area of cutaneous allodynia.

The persistence versus interchangeability of migraine and tension-type headaches in a 5-year population-based validated survey.

The aim of this population-based validated study was to determine the course of tension-type headache and migraine and to evaluate the predictors of persistence.

Psychometric properties of SF-36, EQ-5D, and HADS in patients with chronic pain.

Recent research has highlighted a need for the psychometric evaluation of instruments targeting core domains of the pain experience in chronic pain populations. In this study, the measurement properties of SF-36, EQ-5D, and HADS were analyzed within the item response-theory framework based on data from 35,908 patients. To assess the structural validity of these instruments, the empirical representations of several conceptually substantiated latent structures were compared in a cross-validation procedure. The most structurally sound representations were selected from each questionnaire and their internal consistency reliability computed as a summary of their precision. Lastly, questionnaire scores were correlated to each other to evaluate their convergent and discriminant validity. Our results supported that SF-36 is an acceptable measure of two independent constructs of physical and mental health. In contrast, although the approach to summarize the HRQoL construct of EQ-5D as a unidimensional score was valid, its low reliability rendered practical model implementation of doubtful utility. Finally, rather than being separated into two subscales of anxiety and depression, HADS was a valid and reliable measure of overall emotional distress. In support of convergent and discriminant validity, correlations between questionnaires showed that theoretically similar traits were highly associated whereas unrelated traits were not. Our models can be applied to score SF-36 and HADS in chronic pain patients, but we recommend against using the EQ-5D model due to its low reliability. These results are useful for researchers and clinicians involved in chronic pain populations, as questionnaires' properties determine their discriminating ability in patient status assessment.

Primary stabbing headache in children and adolescents.

To examine the characteristics of primary stabbing headache (PSH) in typically developing children and adolescents.

Search