I am a
Home I AM A Search Login

Human Studies

Share this

A randomized controlled trial of five daily sessions and continuous trial of four weekly sessions of repetitive transcranial magnetic stimulation for neuropathic pain.

We conducted a multicenter, randomized, patient and assessor-blinded, sham-controlled trial to investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) in patients with neuropathic pain. Patients were randomly assigned to receive five daily sessions of active or sham rTMS of M1 corresponding to the part of the body experiencing the worst pain (500 pulses per session at 5 Hz). Responders were invited to enroll in an open-label continuous trial involving four weekly sessions of active rTMS. The primary outcome was a mean decrease in a visual analogue scale (VAS) of pain intensity (scaled 0-100 mm) measured daily during the daily sessions in an intention-to-treat population. Secondary outcomes were other pain scores, quality-of-life measures, and depression score. 144 patients were assigned to the active or sham stimulation groups. The primary outcome, mean VAS decreases, was not significantly different (p=0.58) between the active stimulation group (mean, 8.0) and the sham group (9.2) during the daily sessions. The secondary outcomes were not significantly different between two groups. The patients enrolled in the continuous weekly rTMS achieved more pain relief in the active stimulation group compared with the sham (p<0.01). No serious adverse events were observed. Five daily sessions of rTMS with stimulus conditions used in this trial were ineffective in short-term pain relief in the whole study population with various neuropathic pain. Long-term administration to the responders should be investigated for the clinical use of rTMS on neuropathic pain in the future trials.

Learn More >

A QST-based Pain Phenotype in Adults with Sickle Cell Disease: Sensitivity and Specificity of Quality Descriptors.

We sought to refine a screening measure for discriminating a sensitized or normal sensation pain phenotype among African American adults with sickle cell disease (SCD).

Learn More >

Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine.

Galcanezumab is a humanized immunoglobulin G (IgG) monoclonal antibody (mAb) indicated for the prevention of migraine that binds to calcitonin gene-related peptide. A population pharmacokinetic (PK) analysis was performed to characterize galcanezumab PK using data pooled from 7 clinical studies. Clinical studies included healthy individuals and patients with episodic or chronic migraine who were administered between 5 and 300 mg galcanezumab. The PK data were analyzed using nonlinear mixed-effects modeling. Galcanezumab concentration-time data were described with a 1-compartment model with first-order absorption following subcutaneous administration and linear elimination. At the median body weight of 74 kg, the estimated population apparent clearance (CL/F) was 0.00785 L/h (34% IIV), the apparent volume of distribution was 7.33 L (34% IIV), and half-life was 27 days. Patient body weight was found to have a modest effect of CL/F, with median galcanezumab concentrations being lower in the heaviest patients compared to the lightest patients, but this outcome was determined not to be clinically relevant in the context of model-estimated random variability. Dosing adjusted for body weight is not warranted in adults. Age, sex, race/ethnicity, immunogenicity, renal/hepatic markers, and injection-site location did not affect galcanezumab PK. In conclusion, galcanezumab exhibits PK parameters typical for an IgG mAb administered subcutaneously. The population PK model developed in this study demonstrates that galcanezumab exhibits linear PK that was not influenced in a clinically relevant manner by the patient factors evaluated.

Learn More >

Development and Evaluation of a Screening Tool to Aid the Diagnosis of a Cluster Headache.

Cluster headache (CH), a severe primary headache, is often misdiagnosed and mismanaged. The aim of this study was to develop and evaluate a screening tool to aid the diagnosis of CH. We developed a novel 12-item screening tool. This was comprised of four components: (1) images depicting headache pain; (2) pain descriptors; (3) key questions that could differentiate between CH and migraine; and (4) a visual analogue pain scale. The total possible questionnaire score ranged from 3-32. Patients with CH and migraines (control group) were recruited prospectively from a headache centre in the North of England, UK. Two-hundred and ninety-six patients were included in the study: 81 CH patients, 36 of which suffer with episodic CH and 45 with chronic CH; 215 migraine patients, 92 of which suffer with episodic migraine and 123 with chronic migraine. The mean questionnaire score was higher in CH patients versus migraine patients (28.4 versus 19.5). At a cut-off score of >25 out of 32, the screening tool had a sensitivity of 86.4% and a specificity of 92.0% in differentiating between CH and migraine. The screening tool could be a useful instrument to aid the diagnosis of a CH. The images depicting headache pain do not clearly discriminate between CH and migraine.

Learn More >

Most Bothersome Symptom in Persons With Migraine: Results From the Migraine in America Symptoms and Treatment (MAST) Study.

The objectives of this study were to determine the rates of nausea, phonophobia, and photophobia reported overall and as the most bothersome symptom (MBS) in individuals with migraine and to identify individual characteristics associated with each of the 3 candidate MBSs.

Learn More >

Association between neuropathic pain characteristics and DNA methylation of transient receptor potential ankyrin 1 in human peripheral blood.

Elucidation of epigenetic mechanisms correlating with neuropathic pain in humans is crucial for the prevention and treatment of this treatment-resistant pain state. In the present study, associations between neuropathic pain characteristics and DNA methylation of the transient receptor potential ankyrin 1 (TRPA1) gene were evaluated in chronic pain patients and preoperative patients. Pain and psychological states were prospectively assessed in patients who suffered chronic pain or were scheduled for thoracic surgery. Neuropathic characteristics were assessed using the Douleur Neuropathique 4 (DN4) questionnaire. DNA methylation levels of the CpG islands in the TRPA1 gene were examined using whole blood. Forty-eight adult patients were enrolled in this study. Increases in DNA methylation rates at CpG -51 showed positive correlations with increases in the DN4 score both in preoperative and chronic pain patients. Combined methylation rates at CpG -51 in these patients also significantly increased together with increase in DN4 scores. Neuropathic pain characteristics are likely associated with methylation rates at the promoter region of the TRPA1 gene in human peripheral blood.

Learn More >

Evaluation of genetic risk related to catechol-O-methyltransferase (COMT) and β2-adrenergic receptor (ADRB2) activity in different diagnostic subgroups of temporomandibular disorder in Brazilian patients.

The aim of this study was to evaluate the possible association between polymorphisms in the catechol-O-methyltransferase (COMT) and β2-adrenergic receptor (ADRB2) genes and muscular temporomandibular disorders (TMD). This was a case-control study. Individuals were evaluated using the Research Diagnostic Criteria for Temporomandibular Disorders and were divided into three groups: unaffected (no TMD) (n=154); exclusively muscular TMD (n=49); exclusively articular TMD (n=49). Genomic DNA was obtained from saliva samples, and single nucleotide polymorphisms in the COMT (rs165774, rs6269, rs9332377) and ADRB2 (rs2053044, rs1042713, rs1042714) genes were investigated. The TT genotype for the COMT rs9332377 gene was highly associated with the presence of muscular TMD (P= 0.03). With respect to the ADRB2 gene, the non-polymorphic AA genotype in the rs1042713 region was more prevalent in the articular TMD group than in the muscular TMD group (P= 0.05). This study supports the hypothesis that alterations in the COMT and ADRB2 genes influence the muscular pathophysiology.

Learn More >

Human Abuse Potential of Oral NKTR-181 in Recreational Opioid Users: A Randomized, Double-Blind, Crossover Study.

To evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of oral NKTR-181 (oxycodegol), a novel full mu-opioid receptor agonist, relative to oral oxycodone.

Learn More >

The contribution of purpose in life to psychological morbidity and quality of life in chronic pain patients.

Chronic pain is a cause of morbidity, interference with daily functioning, decreased health and quality of life. Purpose in life acts as a protective factor and mitigates these consequences. This cross-sectional study aimed to determine whether purpose in life contributed to psychological morbidity and quality of life in patients with chronic pain by controlling psychological variables related to health (pain severity and interference, pain perceptions, pain catastrophizing and coping). The sample included 103 patients diagnosed with chronic pain. Results showed that purpose in life independently contributed to psychological morbidity and to mental quality of life, but not to physical quality of life, after controlling for pain-related variables. Results showed the relevance of purpose in life to identify patients at risk of developing psychological morbidity and decreased quality of life, suggestting the need to intervene in chronic pain, specifically on purpose in life, to prevent psychological morbidity and promote quality of life, in this population.

Learn More >

The Course of Orofacial Pain and Jaw Disability after Whiplash Trauma: A 2-year Prospective Study.

Prospective cohort study OBJECTIVE.: To evaluate the course of orofacial pain and jaw disability in relation to neck pain, neck disability and psychosocial factors at the acute stage and the chronic stage after whiplash trauma.Summary of Background Data Many individuals report chronic pain in the orofacial region after whiplash trauma. The possible association between whiplash trauma and orofacial pain is debated. Prospective studies are therefore needed to evaluate the development of orofacial pain after whiplash trauma.

Learn More >

Search