View clinical trials related to Pain.
Filter by:Title Staged Bilateral Carpal Tunnel Release: Which Side Hurts More? Primary null hypothesis Patients undergoing staged bilateral open Carpal Tunnel Release (CTR) have no difference in overall pain intensity of pain between sides. Secondary null hypotheses - There is no correlation in overall pain intensity after open CTR surgery and distal sensory latency, distal motor latency, electromyography (EMG), demographics, occupation, avocation, relevant comorbidities, dominance, left vs. right, Pain Self-Efficacy, Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity or PROMIS depression when both surgeries are performed within 6 months. - There is no difference in satisfaction with treatment at the time of suture removal after the first and second open CTR surgery when both are performed within 6 months.. IRB: 2009-p-001-019 ClinicalTrials.gov: Not mandatory, (b/o observational) Authors: Drijkoningen, Braun, Ring Journal: To be discussed Design: Prospective cohort study Background Many hand surgeons note that patients undergoing staged bilateral open carpal tunnel release often experience more pain with the second side. The investigator felt this was an easily testable hypothesis worthy of study. Subjects Eligibility: Inclusion: - Age 18 or older - Idiopathic carpal tunnel syndrome - No prior surgery for carpal tunnel syndrome Exclude: - Pregnant women - Not fluent in English Response Variables: - 11-point ordinal measure of overall pain intensity during and after surgery measured at the time of suture removal. - 11-point ordinal measure of satisfaction with treatment - PROMIS upper extremity Explanatory Variables: - Distal Sensory Latency (DSL) - Distal Motor Latency (DML) - EMG changes - Demographics: age, sex, race, occupation, avocation - Time limit between two surgeries < 6 months - Relevant comorbidities: Trapeziometacarpal (TMC) arthrosis, ulnar neuropathy, trigger finger - Involved hand (Dominance, Side) - First side vs. second side surgery - PROMIS Pain Interference Computer Adaptive Testing (CAT) - Pain Self Efficacy Questionnaire (PSEQ-2) - PROMIS Depression Methods The investigator and study staff will invite all adult patients (age 18 and older) presenting to the Orthopaedic Hand and Upper Extremity Service Department at Massachusetts General Hospital (MGH) with bilateral carpal tunnel syndrome planning staged bilateral carpal tunnel release. Analysis Power analysis An a priori power analysis for matched pairs was performed. To detect the difference between two dependent means an effect size of 0.5 at alpha of 0.05 and 80% power, a total sample size of 34 patients is needed.As the investigator expects to have patients who will be lost to follow-up the investigators will count 10% extra, a total of 38 patients will be needed. Univariate analysis: Variables will be presented with frequencies and percentages for categorical variables and as mean with standard deviation or median with interquartile range for respectively normal or non-normal distributed continuous variables. Normality of continuous distributed variables will be tested a paired T-Test. Bivariate and multivariable analysis will be performed and subsequently all variables with a probability < 0.10 in bivariate analysis will be inserted in a backward, stepwise, multivariable linear regression analysis to assess their ability to explain variation in outcome. The 11 point Likert Pain scale score is considered significant when there is a difference of more than 1.4 points (2.8 SD*0.5 effect size)on a scale from 1-10.[9]
Pain control is a common and serious problem in cancer patients. Although WHO has developed a three-stage model of cancer pain management, 80% cancer patients still suffer moderate to severe pain in their daily life. When patients are with acute exacerbation or aggravate of pain, they usually visit the emergency department for more help. Acupuncture is a safe, low-invasive and economic treatment. And it has been world-wide used as a complementary therapy among patients with cancer. It can not only relieve pain in cancer patients, but also can reduce some of the side effects caused by some treatment. This study is aimed to evaluate the efficacy and safety of acupuncture in cancer patient with acute pain onset through emergency department with objective Traditional Chinese Medicine assessment.
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.
The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management.
It has been demonstrated that female patients have poor quality of surgical recovery compared to male patients. Increased sensitivity to pain and increased susceptibility to postoperative nausea and vomiting have been attributed as causal factors. Currently, few strategies have been shown to improve quality of recovery in female patients undergoing laparoscopic hysterectomy. A better recovery in female patients undergoing outpatient laparoscopy is particularly desirable since those patients do not have access to potent intravenous medications and nursing support after hospital discharge. Our group has previously demonstrated that both TAP block and systemic lidocaine improve quality of recovery after outpatient laparoscopic gynecological surgery. The TAP block, however, requires expertise, equipment (ultrasound), and additional time to perform as compared with a simple lidocaine infusion. It is currently unknown if a systemic lidocaine infusion provides non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery. The main objective of the current investigation is to examine the effect of TAP block on quality of recovery compared to a systemic lidocaine infusion. We hypothesize that systemic lidocaine infusion would provide non-inferior quality of recovery when compared to TAP block for outpatient laparoscopic gynecological surgery. Significance: This is the first study to compare systemic lidocaine to TAP block with regard to quality of recovery. The research question; does systemic lidocaine provide similar quality of recovery as TAP block for outpatient laparoscopy? The hypothesis; systemic lidocaine provides non-inferior quality of recovery as TAP block for outpatient laparoscopy. Research significance: It has been shown that females have poor surgical recovery compared to males; this project intends to demonstrate that systemic lidocaine provides similar recovery as TAP blocks but it does not require the expertise, equipment, and time needed to perform TAP blocks.
This clinical trial is a double-blind, randomized, within-subject controlled, 2-armed, single-center study sponsored by SciVision Biotech Inc. and approved by National Taiwan University Hospital Research Ethics Committee. The aim of this post-marketing study is to evaluate the safety and efficacy of Hya-Dermis mixed with lidocaine, as well as the effectiveness of corrections of Hya-Dermis mixed with lidocaine. Accounting for potential loss to follow-up, the minimum enrollment was statistically determined to be 40 patients. The study was estimated to be held one and half year including a 0-2 weeks screening period, a day of treatment, and follow-up at month 1, 3, 6, 9, 12. Patient informed consent forms will be obtained before the treatment. A pre-treatment photograph, nasolabial folds (NLF) severity scale scores, and individual aesthetic satisfaction will be the baseline. Two sets of randomized numbers are used, patient numbers and treatment numbers. Participants with odd patient numbers will be assigned to nasolabial group and those with even patient numbers will be assigned to nasolabial&cheekbone group. Participants receive experiment treatment (Hya-Dermis mixed with lidocaine) in one side and control treatment (Hya-Dermis mixed with normal saline) in the other side of the face randomly depending on the treatment numbers. Both physicians and participants are only blind to the treatment assignment. 30 minutes after the injection, a post-photograph will be used to evaluate NLF severity scale scores and global aesthetic improvement scale (GAIS) by physicians. A questionnaire including the Visual Analog Scale (VAS) of pain during the treatment and individual aesthetic satisfaction will be collected from patients. The effectiveness analyses compare NLF severity scale scores and GAIS based on photograph records from physicians, as well as participant questionnaires for each group on every visit. The safety assessment evaluates any recorded adverse events following the device treatment.
This is a phase 4 study being conducted at the Ohio State University Department of Neurology Multiple Sclerosis Research Program. The purpose of the study is to administer a single shot of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has not responded to other pain medicines.
Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In addition,oxytocin have an important roles in sexual reproduction , in particular during and after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin has been commonly used to improve breastfeeding in lactating women. A review of safety , side effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did not review any differences from placebo. The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain. The main objective of the current investigation was to evaluate the effect of intranasal oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain threshold compared to intranasal saline . Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in humans.
Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.
Today, patients with cancer pain in need of opioids for moderate to severe pain get long-acting morphine twice a day and morphine tablets taken on demand in addition. This procedure might be based on the assumption that cancer pain is persistent, although the evidence to support whether this assumption applies to all cancer patients is lacking. Some cancer patients might not need a fixed dose of long-acting morphine. Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an opioid on demand when pain occurs. A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl nasal spray taken on demand, showed that this treatment was apparently feasible and safe for these patients. This approach is studied further in NFCP-II. The participants will be treated with rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary outcome will be patient satisfaction. The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day. After 10 days of treatment there is a crossover and the opposite drug is used for the same participant. Morphine tablets can be taken on demand in all phases of the study. The participants will meet the investigator at inclusion, at the crossover and at the end of treatment. During the study, a diary is filled in by the participants every morning. Questions about pain and side effects are answered. Satisfaction is measured at the crossover and at end of treatment while preference is measured at the end of treatment.