Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial

2019 ◽  
Vol 37 (2) ◽  
pp. 135-143 ◽  
Author(s):  
Jingru Jiang ◽  
Yi Li ◽  
Qingyu Shen ◽  
Xiaoming Rong ◽  
Xiaolong Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Event ◽  
Neuropathic Pain ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Mood States ◽  
Numeric Rating

Purpose Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain. Patients and Methods This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale. Result There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%). Conclusion Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.

scholarly journals Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods This study is designed as a prospective, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China, will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analyzed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5. Trial registration Chinese Clinical Trial Registry ChiCTR1900025469. Registered on 27 August 2019.

W1173 A Single-Item Numeric Rating Scale Shows Excellent Correlation with Measures of Crohn's Disease Activity and Health-Related Quality of Life

2009 ◽  
Vol 136 (5) ◽  
pp. A-670
Author(s):  
Gil Y. Melmed ◽  
Andrew Ippoliti ◽  
Eric A. Vasiliauskas ◽  
Dermot P. McGovern ◽  
Marla Dubinsky ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Health Related Quality ◽  
Excellent Correlation ◽  
Single Item ◽  
Related Quality ◽  
Health Related ◽  
Numeric Rating

Comprehensive Assessment of 1-Year Outcomes and Determination of Minimum Clinically Important Difference in Pain, Disability, and Quality of Life After Suboccipital Decompression for Chiari Malformation I in Adults

Neurosurgery ◽  
2013 ◽  
Vol 73 (4) ◽  
pp. 569-581 ◽  
Author(s):  
Scott L. Parker ◽  
Saniya S. Godil ◽  
Scott L. Zuckerman ◽  
Stephen K. Mendenhall ◽  
John A. Wells ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Short Form ◽  
Minimum Clinically Important Difference ◽  
Numeric Rating Scale ◽  
Pain Disability ◽  
Clinically Important Difference ◽  
Patient Reported ◽  
Difference Thresholds

Abstract BACKGROUND: To date, there has been no study to comprehensively assess the effectiveness of suboccipital craniectomy (SOC) for Chiari malformation I (CMI) using validated patient-reported outcome measures. OBJECTIVE: To determine the effectiveness and minimum clinically important difference thresholds of SOC for the treatment of adult patients with CMI using patient-reported outcome metrics. METHODS: Fifty patients undergoing first-time SOC and C1 laminectomy for CMI at a single institution were followed up for 1 year. Baseline and 1-year postoperative pain, disability, quality of life, patient satisfaction, and return to work were assessed. Minimum clinically important difference thresholds were calculated with 2 anchors: the Health Transition Index and North American Spine Society satisfaction questionnaire. RESULTS: The severity of headaches improved in 37 patients (74%). Improvement in syrinx size was seen in 12 patients (63%) and myelopathy in 12 patients (60%). All patient-reported outcomes showed significant improvement 1 year postoperatively (P < .05). Of the 38 patients (76%) employed preoperatively, 29 (76%) returned to work postoperatively at a median time of 6 weeks (interquartile range, 4-12 weeks). Minimum clinically important difference thresholds after SOC for CMI were 4.4 points for numeric rating scale for headache, 0.7 points for numeric rating scale for neck pain, 13.8 percentage points for Headache Disability Index, 14.2 percentage points for Neck Disability Index, 7.0 points for Short Form-12 Physical Component Summary, 6.1 points for Short Form-12 Mental Component Summary, 4.5 points for Zung depression, 1.7 points for modified Japanese Orthopaedic Association, and 0.34 quality-adjusted life-years for Euro-Qol-5D. CONCLUSION: Surgical management of CMI in adults via SOC provides significant and sustained improvement in pain, disability, general health, and quality of life as assessed by patient-reported outcomes. This patient-centered assessment suggests that suboccipital decompression for CMI in adults is an effective treatment strategy.

scholarly journals Long-Term Outcome After Operative Management of Talus Fractures

2018 ◽  
Vol 39 (12) ◽  
pp. 1432-1443 ◽  
Author(s):  
Wouter Vints ◽  
Giovanni Matricali ◽  
Eric Geusens ◽  
Stefaan Nijs ◽  
Harm Hoekstra
Keyword(s):  
Rating Scale ◽  
Short Form ◽  
Operative Management ◽  
Numeric Rating Scale ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Foot Function ◽  
Numeric Rating

Background: Controversies remain regarding the preferred treatment strategy for talus fractures. The primary goal of this study was to evaluate the long-term outcome after operative management of talus fractures. Secondarily, we identified those factors that affected the outcome and defined strategies to improve the outcome. Methods: This is a retrospective outcome study of 84 patients with an average follow-up time of 9.1 years. We assessed the functional results, return to daily activities, and general health status using the Foot Function Index-5pt, a numeric rating scale for pain, and the Short Form-36 Health Survey. Furthermore, we conducted a correlation analysis between the outcomes and 14 demographic, clinical, and radiologic variables. Results: We found moderate mean Foot Function Index pain and disability scores of 30.2 and 28.7, respectively. The mean numeric rating scale score was 3.2. Of all responders, 41% (27/66) did not return to their daily activities. We reported low physical, but good mental, Short Form-36 component summary scores of 42.7 and 48.3, respectively. We recorded a complication rate of 56%. Osteoarthritis, articular incongruence and talus body fractures correlated significantly with a poorer functional outcome. Delayed surgery after trauma was associated with better outcome measures. Conclusions: Talus fractures have a major long-term impact on ankle and hindfoot function and on physical health. Success of operative treatment depends on the occurrence of osteoarthritis postoperatively, type of fracture, and quality of fracture reduction. Because only the latter is modifiable, efforts should be made to restore articular congruence in order to improve the outcome. Therefore, we recommend reviewing the quality of the reduction postoperatively on CT. Furthermore, talus fractures should not be considered operative emergencies, but rather treated after recovery of the soft-tissues. Level of Evidence: Level III, comparative study.

scholarly journals Characteristics of nasal and intestinal microbiota and effects of probiotics intervention in highly exposed people with PM2.5: a randomized, double-blind, placebo-controlled clinical study

2019 ◽  
Author(s):  
Yongcan Wu ◽  
Caixia Pei ◽  
Xiaomin Wang ◽  
Mingjie Wang ◽  
Demei Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intestinal Microbiota ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
High Exposure ◽  
Gastrointestinal Symptom Rating Scale ◽  
Probiotic Treatment ◽  
High Concentrations

Abstract Background: Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5. Methods: This study is designed as a prospective, 2×2 factorial, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analysed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events. Discussion: We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5.

scholarly journals The Effects of Treatment of Korean Medicine for Superior Labrum Anterior to Posterior Lesions: A Retrospective Chart Review

2020 ◽  
Vol 37 (1) ◽  
pp. 49-58
Author(s):  
Ju-Hun Park ◽  
Hyun-Woo Cho ◽  
Han-Bin Park ◽  
Dong-Hwi Yoo ◽  
Sang-Gyun Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Slap Lesion ◽  
Korean Medicine ◽  
Slap Lesions ◽  
Lesion Type ◽  
The Mean ◽  
Numeric Rating

Background: This study aimed to investigate the clinical effectiveness of treatment of Korean medicine on superior labrum anterior to posterior (SLAP) lesions.Methods: A total of 55 inpatients diagnosed with SLAP lesions by magnetic resonance imaging, were investigated from May 1<sup>st</sup>, 2014 to May 31<sup>st</sup>, 2019 at Haeundae Jaseng Hospital of Korean Medicine. The patients were sorted by gender, age, causing factor, illness duration, period of hospitalization, SLAP lesion type, complications, and treatments. Treatments included acupuncture, pharmacopuncture, Chuna therapy, herbal treatment, and physiotherapy. After treatment, the Numeric Rating Scale, Shoulder Pain and Disability Index, and European Quality of Life 5-Dimension questionnaire were used to evaluate treatment effect.Results: There were more males than females in this study (1:0.83). Patients were more likely to be in their 50s (38.18%), have an unknown etiology (70.91%), and be in the subacute disease stage (41.82%). According to the SLAP lesion type, most of the inpatients had Type 2 lesions (69.09%). For inpatients diagnosed with SLAP lesions, the mean shoulder numeric rating scale score decreased from 5.55 ± 0.90, to 4.07 ± 1.18 (p < 0.001), the mean Shoulder Pain and Disability Index score decreased from 50.35 ± 18.36, to 39.90 ± 19.34 (p < 0.001), and the mean European quality of life 5-dimension index increased from 0.70 ± 0.16, to 0.75 ± 0.13 (p < 0.01) after treatment.Conclusion: Treatment of Korean medicine effectively decreased pain and increased the quality of life of the patients with SLAP lesions in this study.

scholarly journals Persistent Postsurgical Pain Following Thoracotomy: A Comparison of Thoracic Epidural and Paravertebral Blockade as Preventive Analgesia

Pain Medicine ◽  
2019 ◽  
Vol 20 (9) ◽  
pp. 1796-1802
Author(s):  
Jonathon Wong ◽  
Jackie Cooper ◽  
Rik Thomas ◽  
Richard Langford ◽  
Sibtain Anwar
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Short Form ◽  
Postsurgical Pain ◽  
Perioperative Analgesia ◽  
Thoracic Epidural ◽  
Numerical Rating

Abstract Objective Persistent postsurgical pain (PPP) is common following thoracotomy. Thoracic epidural (TEB) and paravertebral blockade (PVB) are both established forms of perioperative analgesia for thoracotomy. There is currently a lack of data on their influence on PPP; this study aims to evaluate both techniques on PPP. Design Observational study, prospectively collected data. Methods Adults who underwent thoracotomy had either TEB or PVB for analgesia and were prospectively interviewed at six months. A numerical rating scale, the short form of the Leeds Assessment of Neuropathic Symptoms and Signs, and the EuroQol-5 dimension (EQ-5D) index were used to assess pain, neuropathic pain, and quality of life. Results Eighty-two patients who underwent a thoracotomy were recruited (TEB N = 36, PVB N = 46). Pain scores had a median (interquartile range [IQR]) of 1 (0 to 4.5) and 1.5 (0 to 4, P = 0.89), presence of PPP was 58.3% (95% confidence interval [CI] = 40.0–74.5%) and 60.9% (95% CI = 45.4–74.9%, P = 0.81), and presence of neuropathic pain was 30.6% (95% CI = 16.3–48.1%) and 28.2% (95% CI = 16.0–43.5%, P = 0.85). Reported quality of life was 0.71 (0.14–0.85) and 0.80 (0.19–0.91, P = 0.21). Patients who had PPP reported worse quality of life measures compared with those who were pain free, with a median (IQR) EQ-5D index of 0.69 (–0.15 to 0.85) and 0.85 (0.72 to 1, P = 0.0007); quality of life was worst when there was a neuropathic component (median = 0.39, IQR = –0.24 to 0.75). Conclusions There was no statistical difference in the development of persistent postsurgical pain between patients who received a TEB or a PVB; however, patients who developed PPP had a significantly lower quality of life, which was worse with a neuropathic component.

The Therapeutic Effects of Acupuncture on Patients with Chronic Neck Myofascial Pain Syndrome: A Single-Blind Randomized Controlled Trial

2010 ◽  
Vol 38 (05) ◽  
pp. 849-859 ◽  
Author(s):  
Mei-Yuan Sun ◽  
Ching-Liang Hsieh ◽  
Yung-Yen Cheng ◽  
Hung-Chang Hung ◽  
Tsai-Chung Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Myofascial Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Myofascial Pain Syndrome ◽  
Randomized Controlled ◽  
Single Blind

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

scholarly journals Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Breast Cancer

2005 ◽  
Vol 23 (25) ◽  
pp. 6027-6036 ◽  
Author(s):  
Patsy Yates ◽  
Sanchia Aranda ◽  
Maryanne Hargraves ◽  
Bev Mirolo ◽  
Alexandra Clavarino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Functional Assessment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Numeric Rating

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

Painful diabetic polyneuropathy and quality of life in Danish type 2 diabetic patients

2017 ◽  
Vol 16 (1) ◽  
pp. 173-173 ◽  
Author(s):  
Sandra Sif Gylfadottir ◽  
Diana Hedevang Christensen ◽  
Sia Kromann Nicolaisen ◽  
Reimar Wernich Thomsen ◽  
Jens Steen Nielsen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Intensity ◽  
Rating Scale ◽  
Diabetic Polyneuropathy ◽  
Numeric Rating Scale ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic

Abstract Background and aims Painful polyneuropathy (PPN) is a disabling complication of diabetes. This study aims to determine its prevalence and relationship with Quality of Life (QoL) in a nationwide prospective cohort of incident recently diagnosed Danish type 2 diabetic patients. Methods We sent a detailed questionnaire on neuropathy, pain and QoL to 6726 patients prospectively enrolled from general practitioners and hospital specialist outpatient clinics into the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort. Patients who reported pain in both feet and a score ≥3 on the Douleur Neuropathique (DN4) questionnaire were considered to have possible PPN. QoL and pain intensity were measured on a numeric rating scale (NRS, 0–10). The Michigan Neuropathy Screening Instrument (MNSI) was used to assess neuropathy. Results A total of 5371 (79.8%) returned a complete questionnaire. 848 (15.8%) recently diagnosed type 2 diabetic patients reported pain in both feet. Of the 619 patients with pain who completed the DN4 questionnaire, 404 (65.2%) had a DN4 score ≥ 3, corresponding to a prevalence in the total population of possible PPN of 10.3%. Mean pain intensity was 5.2 (SD 2.2) and 89% had a MNSI score ≥ 3. Patients with possible PPN had a substantially lower QoL score than those without PPN (median QoL score 6 versus 8 (p < 0.001)), also when correcting for MNSI score. Conclusions Ten percent of newly diagnosed type 2 diabetic patients in Denmark had possible PPN. Patients with PPN had lower QoL than patients without PPN.

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