Baseline endometriosis-associated pain burden: Data from 1600+ women enrolled in elagolix clinical trials

2019 ◽  
Vol 11 (3) ◽  
pp. 117-125 ◽  
Author(s):  
Nicholas Leyland ◽  
Stephanie J Estes ◽  
Samantha Eichner ◽  
Ahmed M Soliman ◽  
Yabing Mai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pelvic Pain ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Phase 3 ◽  
Double Blind ◽  
Scale Range ◽  
Study Participants ◽  
Numeric Rating Scale Score ◽  
Numeric Rating

Background: The daily pain burden experienced by women with endometriosis has not been well studied. Objective: To characterize baseline pain among women with moderate-to-severe endometriosis-associated pain enrolled in phase 3 studies of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist. Study design: Data were pooled from the screening phase of two randomized, double-blind, placebo-controlled clinical trials. After cessation of endometriosis medications, patients entered the screening phase during which symptoms (dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia) and rescue medication use were recorded daily in electronic diaries. Endometriosis-associated pain was also scored using the Numeric Rating Scale (range 0–10). Baseline was defined as the last 35 days during the screening period. Results: Endometriosis-associated pain was reported by the 1686 study participants on most days during the baseline interval. Pain was often moderate or severe, with a mean Numeric Rating Scale score of 5.6 ± 1.7. Women reported dysmenorrhea an average of 8.1 ± 3.0 days (97.9% ± 7.0% of menstruating days), nonmenstrual pelvic pain on 20.5 ± 5.4 days (90.3% ± 15.8% of nonmenstruating days), and dyspareunia on 8.7 ± 8.0 days (81.7% ± 29.7% of sexually active days). When they occurred, dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia were frequently moderate or severe in intensity. Women were free of pelvic pain for an average of 2.4 ± 3.9 days during the 35-day evaluation interval. Conclusion: Among women with untreated moderate-to-severe endometriosis pain, the daily burden of pain was extensive, both during menstruation and on nonmenstruating days.

scholarly journals Effects of Intraoperative Nefopam on Catheter-Related Bladder Discomfort in Patients Undergoing Robotic Nephrectomy: A Randomized Double-Blind Study

2019 ◽  
Vol 8 (4) ◽  
pp. 519
Author(s):  
Chi-Bum In ◽  
Young-Tae Jeon ◽  
Ah-Young Oh ◽  
Se-Jong Jin ◽  
Byeong-Seon Park ◽  
...  
Keyword(s):  
Postoperative Period ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Control Group ◽  
Double Blind Study ◽  
Analgesic Agent ◽  
Double Blind ◽  
Robotic Nephrectomy ◽  
Male Patients ◽  
Numeric Rating

Catheter-related bladder discomfort (CRBD) is one of the most difficult symptoms during the postoperative period. Nefopam is a non-narcotic analgesic agent, which also has anticholinergic action. This study was performed to evaluate the effects of nefopam on CRBD in male patients undergoing robotic nephrectomy. A total of 109 male patients were randomly divided into two groups: the control group (n = 55) received 20 mL of normal saline, and the nefopam group (n = 54) received 20 mg of nefopam 1 h before the end of the operation. At postoperative times of 20 min, 1 h, 2 h, and 6 h, the severity of CRBD was measured using an 11-point numeric rating scale, respectively. The severity of CRBD in the nefopam group was significantly lower than that in the control group at 20 min (4.8 ± 1.3 vs. 2.3 ± 1.0, respectively, p = 0.012) and at 1, 2, and 6 h (3.5 ± 1.2, 2.7 ± 0.9, and 2.5 ± 1.0 vs. 4.1 ± 0.8, 1.6 ± 0.8, and 1.3 ± 0.6, respectively, p < 0001). Intraoperative nefopam administration reduced the severity of CRBD in patients undergoing robotic nephrectomy.

scholarly journals Effects of Korean Medicine Treatment focusing on Acupotomy of headache: A Case Report of Four Patients

2021 ◽  
Vol 42 (3) ◽  
pp. 176-184
Author(s):  
Joohyun Lee ◽  
Hongmin Chu ◽  
Kyungho Kang ◽  
Ju-hyeon Moon ◽  
Jongchul Kim ◽  
...  
Keyword(s):  
Clinical Effect ◽  
Rating Scale ◽  
Case Series ◽  
Numeric Rating Scale ◽  
Attack Frequency ◽  
Headache Attack ◽  
Positive Clinical Effect ◽  
Headache Impact ◽  
Numeric Rating Scale Score ◽  
Numeric Rating

Background: The aim of this study was to report the effect of acupotomy for patients with headache. Methods: Four patients with headache were treated with acupotomy. The improvement of symptoms was evaluated by numeric rating scale(NRS), Headache impact test-6(HIT-6) and headache attack frequency. Results: The numeric rating scale score and headache attack frequency decreased throughout the treatment period. No side effects were observed during treatment. Conclusion: Acupotomy had shown a positive clinical effect in the treatment of a headache in this case series. Further studies are required for its application on various headache.

scholarly journals Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Psychometric Properties ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Routine Clinical Practice ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Numeric Rating

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.

scholarly journals Study protocol for a randomised, double-blind, placebo-controlled study evaluating the Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease: the EMERALD trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029449 ◽  
Author(s):  
Berzenn Urbi ◽  
Simon Broadley ◽  
Richard Bedlack ◽  
Ethan Russo ◽  
Arman Sabet
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Disease Progression ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Motor Neurone ◽  
Double Blind ◽  
Based Medicine ◽  
Numeric Rating ◽  
Lateral Sclerosis

IntroductionAmyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder with no known cure and with an average life expectancy of 3–5 years post diagnosis. The use of complementary medicine such as medicinal cannabis in search for a potential treatment or cure is common in ALS. Preclinical studies have demonstrated the efficacy of cannabinoids in extending the survival and slowing of disease progression in animal models with ALS. There are anecdotal reports of cannabis slowing disease progression in persons with ALS (pALS) and that cannabis alleviated the symptoms of spasticity and pain. However, a clinical trial in pALS with these objectives has not been conducted.Methods and analysisThe Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease trial is a randomised, double-blind, placebo-controlled cannabis trial in pALS conducted at the Gold Coast University Hospital, Australia. The investigational product will be a cannabis-based medicine extract (CBME) supplied by CannTrust Inc., Canada, with a high-cannabidiol-low-tetrahydrocannabinol concentration. A total of 30 pALS with probable or definite ALS diagnosis based on the El Escorial criteria, with a symptom duration of <2 years, age between 25 and 75years and with at least 70% forced vital capacity (FVC) will be treated for 6 months. The primary objective of the study is to evaluate the efficacy of CBME compared with placebo in slowing the disease progression measured by differences in mean ALS Functional Rating Scale-Revised and FVC score between the groups at the end of treatment. The secondary objectives are to evaluate the safety and tolerability of CBME by summarising adverse events, the effects of CBME on spasticity, pain, weight loss and quality of life assessed by the differences in mean Numeric Rating Scale for spasticity and Numeric Rating Scale for pain, percentage of total weight loss and ALS specific quality of life-Revised questionnaire.Ethics and disseminationThe study has been approved by the local Institutional Review Board. The results of this study will be published in a peer-reviewed journal.Trial registration numberNCT03690791

Comparison of the Effectiveness between 5% Eutectic Mixture of Local Anesthetic Cream and Ethyl Chloride Spray Applied on the Skin Prior to Intravenous Cannulation

2021 ◽  
Vol 104 (1) ◽  
pp. 73-78
Keyword(s):  
Local Anesthetic ◽  
Pain Perception ◽  
Rating Scale ◽  
Eutectic Mixture ◽  
Numeric Rating Scale ◽  
Ethyl Chloride ◽  
Endoscopic Procedure ◽  
Pain Scores ◽  
Study Participants ◽  
Numeric Rating

Background: Since the patients scheduled for an endoscopic procedure had been unhappy with pain during intravenous cannulation. Objective: To compare the effectiveness between 5% eutectic mixture of local anesthetic cream and ethyl chloride spray applied on the skin prior to the procedure. Materials and Methods: One hundred eighty-six patients were randomized equally into three groups, A: 5% eutectic mixture of local anesthetic cream, B: ethyl chloride spray, and C: placebo. Then a nurse used a 22-gauge (22G) needle catheter to administer a cannula. Five minutes after the intravenous cannulation, a co-researcher assessed the patient’s pain perception and satisfaction as well as the nurse’s difficulty in performance by means of a numeric rating scale. Results: One hundred seventy-six patients completed the present study. Participants having the anesthetic cream and spray application as well as the placebo expressed their pain scores as 1.7±1.3, 1.6±1.2, and 2.2±1.3, respectively. Therefore, patients applied with local anesthetics had significantly less pain perception than those with the placebo (p=0.039); however, scores were not different between the anesthetic cream and the spray groups. Conclusion: Patients scheduled for an endoscopic procedure did not showed significant pain relief with either the 5% eutectic mixture of local anesthetic cream or the ethyl chloride spray. Keywords: 5% eutectic mixture of local anesthetic cream, Ethyl chloride spray, Endoscopic surgery, Intravenous cannulation, Pain

Pain after Cardiac Surgery

2006 ◽  
Vol 105 (4) ◽  
pp. 794-800 ◽  
Author(s):  
Pasi Lahtinen ◽  
Hannu Kokki ◽  
Markku Hynynen
Keyword(s):  
Cardiac Surgery ◽  
Postoperative Pain ◽  
Scale Score ◽  
Severe Pain ◽  
Rating Scale ◽  
Artery Bypass ◽  
Numeric Rating Scale ◽  
Persistent Pain ◽  
Numeric Rating Scale Score ◽  
Numeric Rating

Background Persistent chest pain may originate from cardiac surgery. Conflicting results have been reported on the incidence of persistent poststernotomy pain with considerable discrepancies between the retrospective reports and the one prospective study conducted to assess this pain. Therefore, the authors conducted a follow-up survey for the first 12 months after cardiac surgery in 213 patients who had a sternotomy. Methods The authors performed a prospective inquiry of acute and chronic poststernotomy pain both before and after cardiac surgery. Two hundred thirteen coronary artery bypass patients received a questionnaire preoperatively, 4 days postoperatively, and 1, 3, 6, and 12 months postoperatively. All patients were asked about their expectations, their preferences, and the location and intensity of postoperative pain. Results The return rates for the postal questionnaires were 203 (95%) and 186 (87%) after 1 and 12 months, respectively. Patients experienced more pain postoperatively at rest than they had expected to preoperatively. At rest, the worst actual postoperative pain was 6 (0-10), and the worst expected pain as assessed preoperatively was 5 (0-10) (P = 0.013). The worst reported postoperative pain was severe (numeric rating scale score 7-10) in 49% at rest, in 78% during coughing, and in 62% of patients on movement. One year after the operation, 26 patients (14%) reported mild chronic poststernotomy pain at rest, 1 patient (1%) had moderate pain, and 3 patients (2%) had severe pain. Upon movement, persistent pain was even more common: 45 patients (24%) had mild, 5 patients (3%) had moderate, and 7 patients (4%) had severe pain. Patients who experienced moderate to severe acute postoperative pain also reported any chronic poststernotomy pain (numeric rating scale score 1-10) more frequently. Conclusions Although common, the incidence of persistent pain after sternotomy was lower than previously reported. Also, reassuringly, 1 year after surgery this pain was mostly mild in nature both at rest and on movement.

Effect of Fentanyl Nasal Packing Treatment on Patients With Acute Postoperative Pain After Nasal Operation: A Randomized Double-Blind Controlled Trial

2018 ◽  
Vol 127 (5) ◽  
pp. 297-305 ◽  
Author(s):  
Kwan-Sub Kim ◽  
Nam-Kyung Yeo ◽  
Seong-Su Kim ◽  
Woong-Sub Park ◽  
Su-Hyun Kwak ◽  
...  
Keyword(s):  
Endoscopic Sinus Surgery ◽  
Rating Scale ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Sinus Surgery ◽  
Control Group ◽  
Double Blind ◽  
Ramsay Sedation Scale ◽  
Numeric Rating ◽  
Fentanyl Group

Purpose: Nasal packing is an option for bleeding control after endoscopic sinus surgery and septoplasty. Although new packing materials have been developed, patients still suffer from pain and require additional analgesics treatments. In this study, a prospective, randomized, and double-blind controlled trial was designed to evaluate the effect of fentanyl-soaked packing on pain after endoscopic sinus surgery and septoplasty. Methods: One hundred fifty-two patients who underwent nasal surgeries due to chronic rhinosinusitis or nasal septal deviation were enrolled in this study. At the end of operation, 50 mcg fentanyl-soaked biodegradable synthetic polyurethane foams packing Nasopore or Merocel were applied to a group of 79 patients, and saline-soaked ones were applied to another group of 73 patients. To evaluate the influence of fentanyl on postoperative nasal pain, patients’ conditions were assessed via means of Numeric Rating Scale, patient satisfaction, and Ramsay Sedation Scale. In addition, symptoms of headache or sore throat and any signs of cardiopulmonary-relevant indicators were monitored. Results: The fentanyl group had significantly decreased Numeric Rating Scale and increased patient satisfaction in every operation type for the majority of postoperative time periods ( P < .05) with reduced postoperative headache and sore throat compared to the control group. The fentanyl group showed a higher score on Ramsay Sedation Scale than the control group ( P < .05 in group including endoscopic sinus surgery). There were no significant differences in cardiopulmonary-relevant indicators between the 2 groups ( P > .05). Conclusion: Fentanyl group showed significantly reduced postoperative pain without serious adverse effects. We suggest that topical fentanyl application to nasal packs can be a useful method to reduce pain during the early postoperative period after endoscopic sinus surgery and septoplasty.

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