Showing papers on "Visual analogue scale published in 2020"

Clinical Evidence for Association of Acupuncture and Acupressure With Improved Cancer Pain: A Systematic Review and Meta-Analysis

Abstract: Importance Research into acupuncture and acupressure and their application for cancer pain has been growing, but the findings have been inconsistent. Objective To evaluate the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Data Sources Three English-language databases (PubMed, Embase, and CINAHL) and 4 Chinese-language biomedical databases (Chinese Biomedical Literature Database, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure, and Wanfang) were searched for RCTs published from database inception through March 31, 2019. Study Selection Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. Data Extraction and Synthesis Data were screened and extracted independently using predesigned forms. The quality of RCTs was appraised with the Cochrane Collaboration risk of bias tool. Random-effects modeling was used to calculate the effect sizes of included RCTs. The quality of evidence was evaluated with the Grading of Recommendations Assessment, Development and Evaluation approach. Main Outcomes and Measures The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale. Results A total of 17 RCTs (with 1111 patients) were included in the systematic review, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity (mean difference [MD], −1.38 points; 95% CI, −2.13 to −0.64 points;I2 = 81%). A favorable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity (MD, −1.44 points; 95% CI, −1.98 to −0.89;I2 = 92%) and in 2 RCTs for reducing opioid dose (MD, −30.00 mg morphine equivalent daily dose; 95% CI, −37.5 mg to −22.5 mg). The evidence grade was moderate because of the substantial heterogeneity among studies. Conclusions and Relevance This systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.

Comparison of treatments for frozen shoulder: a systematic review and meta-analysis

Abstract: Importance: There are a myriad of available treatment options for patients with frozen shoulder, which can be overwhelming to the treating health care professional. Objective: To assess and compare the effectiveness of available treatment options for frozen shoulder to guide musculoskeletal practitioners and inform guidelines. Data Sources: Medline, EMBASE, Scopus, and CINHAL were searched in February 2020. Study Selection: Studies with a randomized design of any type that compared treatment modalities for frozen shoulder with other modalities, placebo, or no treatment were included. Data Extraction and Synthesis: Data were independently extracted by 2 individuals. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Random-effects models were used. Main Outcomes and Measures: Pain and function were the primary outcomes, and external rotation range of movement (ER ROM) was the secondary outcome. Results of pairwise meta-analyses were presented as mean differences (MDs) for pain and ER ROM and standardized mean differences (SMDs) for function. Length of follow-up was divided into short-term (≤12 weeks), mid-term (>12 weeks to ≤12 months), and long-term (>12 months) follow-up. Results: From a total of 65 eligible studies with 4097 participants that were included in the systematic review, 34 studies with 2402 participants were included in pairwise meta-analyses and 39 studies with 2736 participants in network meta-analyses. Despite several statistically significant results in pairwise meta-analyses, only the administration of intra-articular (IA) corticosteroid was associated with statistical and clinical superiority compared with other interventions in the short-term for pain (vs no treatment or placebo: MD, −1.0 visual analog scale [VAS] point; 95% CI, −1.5 to −0.5 VAS points; P < .001; vs physiotherapy: MD, −1.1 VAS points; 95% CI, −1.7 to −0.5 VAS points; P < .001) and function (vs no treatment or placebo: SMD, 0.6; 95% CI, 0.3 to 0.9; P < .001; vs physiotherapy: SMD 0.5; 95% CI, 0.2 to 0.7; P < .001). Subgroup analyses and the network meta-analysis demonstrated that the addition of a home exercise program with simple exercises and stretches and physiotherapy (electrotherapy and/or mobilizations) to IA corticosteroid may be associated with added benefits in the mid-term (eg, pain for IA coritocosteriod with home exercise vs no treatment or placebo: MD, −1.4 VAS points; 95% CI, −1.8 to −1.1 VAS points; P < .001). Conclusions and Relevance: The findings of this study suggest that the early use of IA corticosteroid in patients with frozen shoulder of less than 1-year duration is associated with better outcomes. This treatment should be accompanied by a home exercise program to maximize the chance of recovery.

Gefapixant in two randomised dose-escalation studies in chronic cough

Abstract: Background and objectives Gefapixant has previously demonstrated efficacy in the treatment of refractory chronic cough at a high daily dose. The current investigations explore efficacy and tolerability of gefapixant, a P2X3 receptor antagonist, for the treatment of chronic cough using a dose-escalation approach. Materials and methods Two randomised, double-blind, placebo-controlled, crossover, dose-escalation studies recruited participants with refractory chronic cough. Patients were assigned to receive ascending doses of gefapixant (study 1: 50–200 mg, study 2: 7.5–50 mg) or placebo for 16 days, then crossed-over after washout. The primary end-point was awake cough frequency assessed using a 24-h ambulatory cough monitor at baseline and on day 4 of each dose. Patient-reported outcomes included a cough severity visual analogue scale and the cough severity diary. Results In clinical studies, gefapixant doses ≥30 mg produced maximal improvements in cough frequency compared with placebo (p Conclusions P2X3 antagonism with gefapixant demonstrates anti-tussive efficacy and improved tolerability at lower doses than previously investigated. Studies of longer duration are warranted.

Dupilumab improves health-related quality of life in patients with chronic rhinosinusitis with nasal polyposis.

Abstract: Background Chronic rhinosinusitis with nasal polyposis (CRSwNP) negatively affects health-related quality of life (HRQoL). In a previously reported randomized clinical trial (NCT01920893), addition of dupilumab to mometasone furoate in patients with CRSwNP refractory to intranasal corticosteroids (INCS) significantly improved endoscopic, radiographic, and clinical endpoints and patient-reported outcomes. The objective of this analysis was to examine the impact of dupilumab treatment on HRQoL and productivity using secondary outcome data from this trial. Methods Following a 4-week mometasone furoate nasal spray run-in, patients were randomized to commence subcutaneous dupilumab (600 mg loading dose, then 300 mg once weekly for 15 weeks [n = 30], or matched placebo [n = 30]). Outcomes included scores on the CRS disease severity visual analog scale (VAS), 22-item Sino-Nasal Outcome Test (SNOT-22), 5-dimension EuroQoL (EQ-5D) general health status VAS, and 36-item Short-Form Health Survey (SF-36) for HRQoL and nasal polyp-related healthcare resource use questionnaires. Results Following 16 weeks of treatment, the proportion of patients with moderate-to-severe CRSwNP (VAS > 3-10) decreased from 86.2% to 21.4% with dupilumab and 88.0% to 84.2% with placebo. Dupilumab (vs placebo) resulted in significantly greater improvement in HRQoL, based on SNOT-22, SF-36, and EQ-5D VAS scores. The dupilumab group had a significantly lower adjusted annualized mean number of sick leave days (0.09, vs 4.18 with placebo, P = .015) and significantly greater improvement (vs placebo) in the SNOT-22 item "reduced productivity." Conclusions In adults with CRSwNP refractory to treatment with INCS alone, the addition of dupilumab reduced disease severity, significantly improved HRQoL, and improved productivity.

Lumbar Degenerative Disease Part 1: Anatomy and Pathophysiology of Intervertebral Discogenic Pain and Radiofrequency Ablation of Basivertebral and Sinuvertebral Nerve Treatment for Chronic Discogenic Back Pain: A Prospective Case Series and Review of Literature.

Abstract: Degenerative disc disease is a leading cause of chronic back pain in the aging population in the world. Sinuvertebral nerve and basivertebral nerve are postulated to be associated with the pain pathway as a result of neurotization. Our goal is to perform a prospective study using radiofrequency ablation on sinuvertebral nerve and basivertebral nerve; evaluating its short and long term effect on pain score, disability score and patients’ outcome. A review in literature is done on the pathoanatomy, pathophysiology and pain generation pathway in degenerative disc disease and chronic back pain. 30 patients with 38 levels of intervertebral disc presented with discogenic back pain with bulging degenerative intervertebral disc or spinal stenosis underwent Uniportal Full Endoscopic Radiofrequency Ablation application through either Transforaminal or Interlaminar Endoscopic Approaches. Their preoperative characteristics are recorded and prospective data was collected for Visualized Analogue Scale, Oswestry Disability Index and MacNab Criteria for pain were evaluated. There was statistically significant Visual Analogue Scale improvement from preoperative state at post-operative 1wk, 6 months and final follow up were 4.4 ± 1.0, 5.5 ± 1.2 and 5.7 ± 1.3, respectively, p < 0.0001. Oswestery Disability Index improvement from preoperative state at 1week, 6 months and final follow up were 45.8 ± 8.7, 50.4 ± 8.2 and 52.7 ± 10.3, p < 0.0001. MacNab criteria showed excellent outcomes in 17 cases, good outcomes in 11 cases and fair outcomes in 2 cases Sinuvertebral Nerve and Basivertebral Nerve Radiofrequency Ablation is effective in improving the patients’ pain, disability status and patient outcome in our study.

Digital Care for Chronic Musculoskeletal Pain: 10,000 Participant Longitudinal Cohort Study.

Abstract: Background: Chronic musculoskeletal pain has a vast global prevalence and economic burden. Conservative therapies are universally recommended but require patient engagement and self-management to be effective. Objective: This study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain. Methods: A longitudinal observational study was conducted using a remote DCP available through a mobile app. Subjects participated in a 12-week multimodal DCP incorporating education, sensor-guided exercise therapy (ET), and behavioral health support with 1-on-1 remote health coaching. The primary outcome was pain measured by the visual analog scale (VAS). Secondary measures included engagement levels, program completion, program satisfaction, condition-specific pain measures, depression, anxiety, and work productivity. Results: A total of 10,264 adults with either knee (n=3796) or low back (n=6468) pain for at least three months were included in the study. Participants experienced a 68.45% average improvement in VAS pain between baseline intake and 12 weeks. In all, 73.04% (7497/10,264) participants completed the DCP into the final month. In total, 78.60% (5893/7497) of program completers (7144/10,264, 69.60% of all participants) achieved minimally important change in pain. Furthermore, the number of ET sessions and coaching interactions were both positively associated with improvement in pain, suggesting that the amount of engagement influenced outcomes. Secondary outcomes included a 57.9% and 58.3% decrease in depression and anxiety scores, respectively, and 61.5% improvement in work productivity. Finally, 3 distinct clusters of pain response trajectories were identified, which could be predicted with a mean 76% accuracy using baseline measures. Conclusions: These results support the efficacy and scalability of a DCP for chronic low back and knee pain in a large, diverse, real-world population. Participants demonstrated high completion and engagement rates and a significant positive relationship between engagement and pain reduction was identified, a finding that has not been previously demonstrated in a DCP. Furthermore, the large sample size allowed for the identification of distinct pain response subgroups, which may prove beneficial in predicting recovery and tailoring future interventions. This is the first longitudinal digital health study to analyze pain outcomes in a sample of this magnitude, and it supports the prospect for DCPs to serve the overwhelming number of musculoskeletal pain sufferers worldwide.

Totally endoscopic sublay (TES) repair for midline ventral hernia: surgical technique and preliminary results

Abstract: The Rives–Stoppa procedure is used for ventral hernia repair but requires a large midline incision. This report describes a new, totally endoscopic approach to the retromuscular plane, corresponding to a reversed totally extraperitoneal procedure, to perform sublay repair of primary and secondary ventral hernias. This totally endoscopic sublay (TES) repair is described in detail, and its safety and efficacy were evaluated. In this prospective study, we assessed 26 consecutive primary and secondary epigastric midline ventral hernias that were repaired between July 2017 and July 2018 using the TES procedure. A large mesh was placed in the retrorectus position using this minimally invasive approach. Indications for this procedure include umbilical, epigastric, incisional hernias, and rectus diastasis. All TES procedures were successfully performed without conversion to an open operation. The mean operative time was 106.6 ± 29.1 min (range 75–205), with average mesh area of 318.8 cm2 for an average defect area of 26.5 cm2. Postoperative pain was mild, and the mean visual analog scale (VAS) under physical stress (e.g., climbing stairs) was 2.4 at the third postoperative day. The average postoperative hospital stay was 2.8 ± 0.8 days (range 2–5). Two patients developed postoperative seroma, with no final adverse effect. No recurrence nor readmissions within 30 days was observed during a mean follow-up of 9.2 ± 4.4 months. Initial experiences with this technique show that the TES procedure is safe and reliable, requires no specific instruments, and is highly reproducible. There is no need for an expensive anti-adhesion mesh or fixation device, making it cost-effective.

The negative impact of the COVID-19 lockdown on pain and physical function in patients with end-stage hip or knee osteoarthritis.

Abstract: Purpose The purpose of this study was to evaluate pain, functional impairment, mental health, and daily activity in patients with end-stage hip and knee osteoarthritis (OA) during the COVID-19 lockdown. Methods The study included 63 patients, with hip or knee OA, who had been scheduled for arthroplasty that was postponed because of COVID-19. Patients were evaluated by telephone interviews during the first week after lockdown, in the fourth week, and again at the end of the lockdown. Patients rated their pain level on the basis of a visual analog scale (VAS) and completed WOMAC, SF-12 and Tegner activity scale (TAS) questionnaires. Results VAS and WOMAC scores increased significantly during lockdown, while physical activity significantly decreased. At the final evaluation, VAS and WOMAC showed a significant negative correlation with TAS. The SF-12 subscale scores showed a significant decrease of the physical component during the lockdown, while the mental component remained largely unchanged. Patients with knee OA showed a faster progress of pain compared to those with hip OA. 50 patients (79%) stated they wished to have arthroplasty as soon as possible. Conclusion The COVID-19 lockdown had a significant impact on pain, joint function, physical function, and physical activity in patients with end-stage hip and knee OA. Level of evidence II (Prospective cohort study).

Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial.

Abstract: Background Pain after total knee arthroplasty (TKA) affects postoperative recovery and patient satisfaction. The analgesic benefits of corticosteroids have not been well studied. We, therefore, investigated the analgesic effects of intravenous (IV) dexamethasone (DEX) in patients undergoing a TKA. Methods This was a randomized, double-blind, placebo-controlled trial of 0.15 mg/kg of IV DEX vs saline placebo in unilateral TKA. Fifty patients/arm were recruited. Primary outcomes were pain level, determined by a visual analog scale, and the amount of morphine consumption (mg) ≤48 hours post-TKA. Secondary outcomes were rates of nausea and vomiting, C-reactive protein concentrations, and functional outcomes. Results The DEX group had a significantly lower mean visual analog scale score both at rest and during motion at 12, 15, 18, and 21 hours (P .05). Conclusion IV DEX relieves postoperative pain between 12 to 21 hours after TKA and may be a useful adjunct for controlling pain in patients undergoing TKA.

A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids?

Abstract: Purpose To determine whether postsurgical pain, measured by the visual analog scale (VAS), following common orthopaedic sports procedures could be managed effectively with a nonopioid multimodal analgesic protocol. Methods This prospective study evaluated a custom multimodal nonopioid pain protocol in patients undergoing common orthopaedic sports procedures by a single fellowship-trained orthopaedic sports surgeon from May 2018 to December 2018. Procedures included anterior cruciate ligament reconstruction, rotator cuff repair, arthroscopic partial meniscectomy, and labrum repair. The nonopioid pain protocol consisted of preoperative analgesics, intraoperative local infiltration analgesia, and a postoperative pain regimen. Patient pain was immediately reported after surgery and 1 week postoperatively using the VAS, whereas rescue opioids (oxycodone 5 mg) used were recorded using a prescription opioid journal. Statistical analysis of patient VAS scores, demographic correlations, and comparison between opioid rescue users versus nonusers was performed. Results A total of 141 patients were included. One week following surgery, patients reported a mean VAS level of 3.2 ± 2.3 and required on average 2.6 ± 3.6 breakthrough oxycodone pills (8.6 ± 12.0 morphine equivalents). Forty-five percent of patients did not require any breakthrough prescription opioids and reported satisfaction with pain management. Patients who required opioids were more likely to have a history of anxiety/depression (44.2% vs 23.8%, P = .012) and reported greater pain scores as compared with nonusers (3.94 ± 2.5 vs 2.41 ± 1.75, P = .016). The most common side effect of the pain protocol was feeling drowsy (23.5%). All patients were satisfied with their pain management postoperatively. Conclusions A multimodal, nonopioid pain protocol was found to be effective in managing postoperative pain following common orthopedic sports procedures. Patients were found to have low levels of pain, require minimal rescue opioids, and had no severe side effects related to the protocol. These results suggest a nonopioid alternative to pain management following common orthopedic sports procedures. Level of Evidence Level IV, prospective case series

Management of Fatigue in Rheumatoid Arthritis

Abstract: Fatigue in rheumatoid arthritis is highly prevalent. It is correlated only weakly with disease activity but more so with pain, mood, personality features, poor sleep, obesity and comorbidities. Fatigue can be measured by many standardised questionnaires and more easily with a Visual Analogue Scale or numeric rating scale. Most patients with RA have some fatigue, and at least one in six have severe fatigue. Chronic pain and depressed mood are also common in RA patients with significant fatigue. It affects function and quality of life and is worse on average in women. Evidence-based treatment for fatigue includes treatment of underlying disease activity (with on average modest improvement of fatigue), exercise programmes and supervised self-management programmes with cognitive-behavioural therapy, mindfulness and reinforcement (such as reminders). The specific programmes for exercise and behavioural interventions are not standardised. Some medications cause fatigue such as methotrexate. More research is needed to understand fatigue and how to treat this common complex symptom in RA that can be the worst symptom for some patients.

Quality of Life of Cancer Patients Treated with Chemotherapy.

Abstract: Background: Life-quality tests are the basis for assessing the condition of oncological patients. They allow for obtaining valuable information from the patients regarding not only the symptoms of disease and adverse effects of the treatment but also assessment of the psychological, social and spiritual aspects. Taking into account assessment of the quality of life made by the patient in the course of disease has a positive effect on the well-being of patients, their families and their caregivers as well as on satisfaction with the interdisciplinary and holistic oncological care. Methods: A population-based, multi-area cross-sectional study was conducted among patients with cancer in the study in order to assess their life quality. The method used in the study was a clinical interview. Quality of life was measured using the EQ-5D-5L Quality of Life Questionnaire, the Karnofsky Performance Status, our own symptom checklist, Edmonton Symptom Assessment and Visual Analogue Scale. Results: In the subjective assessment of fitness, after using the Karnofsky fitness index, it was shown that 28% (95% CI (confidence interval): 27–30) of patients declared the ability to perform normal physical activity. In the assessment the profile, quality of life and psychometric properties of EQ-5D-5L, it was shown that patients had the most severe problems in terms of self-care (81%, 95% CI: 76–89) and feeling anxious and depressed (63%, 95% CI: 60–68). Conclusions: Cancer undoubtedly has a negative impact on the quality of life of patients, which is related to the disease process itself, the treatment used and the duration of the disease.

Acupuncture for chronic nonspecific low back pain

Abstract: Background Chronic nonspecific low back pain (LBP) is very common; it is defined as pain without a recognizable etiology that lasts for more than three months. Some clinical practice guidelines suggest that acupuncture can offer an effective alternative therapy. This review is a split from an earlier Cochrane review and it focuses on chronic LBP. Objectives To assess the effects of acupuncture compared to sham intervention, no treatment, or usual care for chronic nonspecific LBP. Search methods We searched CENTRAL, MEDLINE, Embase, CINAHL, two Chinese databases, and two trial registers to 29 August 2019 without restrictions on language or publication status. We also screened reference lists and LBP guidelines to identify potentially relevant studies. Selection criteria We included only randomized controlled trials (RCTs) of acupuncture for chronic nonspecific LBP in adults. We excluded RCTs that investigated LBP with a specific etiology. We included trials comparing acupuncture with sham intervention, no treatment, and usual care. The primary outcomes were pain, back-specific functional status, and quality of life; the secondary outcomes were pain-related disability, global assessment, or adverse events. Data collection and analysis Two review authors independently screened the studies, assessed the risk of bias and extracted the data. We meta-analyzed data that were clinically homogeneous using a random-effects model in Review Manager 5.3. Otherwise, we reported the data qualitatively. We used the GRADE approach to assess the certainty of the evidence. Main results We included 33 studies (37 articles) with 8270 participants. The majority of studies were carried out in Europe, Asia, North and South America. Seven studies (5572 participants) conducted in Germany accounted for 67% of the participants. Sixteen trials compared acupuncture with sham intervention, usual care, or no treatment. Most studies had high risk of performance bias due to lack of blinding of the acupuncturist. A few studies were found to have high risk of detection, attrition, reporting or selection bias. We found low-certainty evidence (seven trials, 1403 participants) that acupuncture may relieve pain in the immediate term (up to seven days) compared to sham intervention (mean difference (MD) -9.22, 95% confidence interval (CI) -13.82 to -4.61, visual analogue scale (VAS) 0-100). The difference did not meet the clinically important threshold of 15 points or 30% relative change. Very low-certainty evidence from five trials (1481 participants) showed that acupuncture was not more effective than sham in improving back-specific function in the immediate term (standardized mean difference (SMD) -0.16, 95% CI -0.38 to 0.06; corresponding to the Hannover Function Ability Questionnaire (HFAQ, 0 to 100, higher values better) change (MD 3.33 points; 95% CI -1.25 to 7.90)). Three trials (1068 participants) yielded low-certainty evidence that acupuncture seemed not to be more effective clinically in the short term for quality of life (SMD 0.24, 95% CI 0.03 to 0.45; corresponding to the physical 12-item Short Form Health Survey (SF-12, 0-100, higher values better) change (MD 2.33 points; 95% CI 0.29 to 4.37)). The reasons for downgrading the certainty of the evidence to either low to very low were risk of bias, inconsistency, and imprecision. We found moderate-certainty evidence that acupuncture produced greater and clinically important pain relief (MD -20.32, 95% CI -24.50 to -16.14; four trials, 366 participants; (VAS, 0 to 100), and improved back function (SMD -0.53, 95% CI -0.73 to -0.34; five trials, 2960 participants; corresponding to the HFAQ change (MD 11.50 points; 95% CI 7.38 to 15.84)) in the immediate term compared to no treatment. The evidence was downgraded to moderate certainty due to risk of bias. No studies reported on quality of life in the short term or adverse events. Low-certainty evidence (five trials, 1054 participants) suggested that acupuncture may reduce pain (MD -10.26, 95% CI -17.11 to -3.40; not clinically important on 0 to 100 VAS), and improve back-specific function immediately after treatment (SMD: -0.47; 95% CI: -0.77 to -0.17; five trials, 1381 participants; corresponding to the HFAQ change (MD 9.78 points, 95% CI 3.54 to 16.02)) compared to usual care. Moderate-certainty evidence from one trial (731 participants) found that acupuncture was more effective in improving physical quality of life (MD 4.20, 95% CI 2.82 to 5.58) but not mental quality of life in the short term (MD 1.90, 95% CI 0.25 to 3.55). The certainty of evidence was downgraded to moderate to low because of risk of bias, inconsistency, and imprecision. Low-certainty evidence suggested a similar incidence of adverse events immediately after treatment in the acupuncture and sham intervention groups (four trials, 465 participants) (RR 0.68 95% CI 0.46 to 1.01), and the acupuncture and usual care groups (one trial, 74 participants) (RR 3.34, 95% CI 0.36 to 30.68). The certainty of the evidence was downgraded due to risk of bias and imprecision. No trial reported adverse events for acupuncture when compared to no treatment. The most commonly reported adverse events in the acupuncture groups were insertion point pain, bruising, hematoma, bleeding, worsening of LBP, and pain other than LBP (pain in leg and shoulder). Authors' conclusions We found that acupuncture may not play a more clinically meaningful role than sham in relieving pain immediately after treatment or in improving quality of life in the short term, and acupuncture possibly did not improve back function compared to sham in the immediate term. However, acupuncture was more effective than no treatment in improving pain and function in the immediate term. Trials with usual care as the control showed acupuncture may not reduce pain clinically, but the therapy may improve function immediately after sessions as well as physical but not mental quality of life in the short term. The evidence was downgraded to moderate to very low-certainty considering most of studies had high risk of bias, inconsistency, and small sample size introducing imprecision. The decision to use acupuncture to treat chronic low back pain might depend on the availability, cost and patient's preferences.

Quality of life in elderly people after a hip fracture: a prospective study

Abstract: Hip fracture is an important social and medical problem due to its increasing prevalence, the consequences for health and the economic impact on the health care system, but there is no doubt that it also has repercussions on health-related quality of life (HRQoL). Hence the importance of understanding and determining the impact of the condition on everyday life from the perspective of the patient’s physical, emotional and social well-being. To determine the impact of hip fracture on HRQoL of people over the age of 65 1 month after surgery, related factors and the effects on functional ability and mood. Prospective observational study conducted in the traumatology units of two university hospitals in the province of Caceres with consecutive sampling of all patients over the age of 65 admitted for hip fracture surgery during the study period. Sociodemographic and clinical data were recorded at the time of admission and prospectively at the follow-up visit 1 month later. Clinical, social, quality of life (EQ-5D-), basic functional and instrumental capacity (Barthel Index (BI) and Lawton & Brody Scale), and geriatric depression (Yesavage) variables were collected. The study included 224 patients with a median age of 84.6 years (SD ± 6.1), 76.3% were female. Charlson’s comorbidity was 5.3 (SD ± 1.2). The EQ-5D index decreased from 0.62 (SD ± 0.35) to 0.16 at 1 month follow up (SD ± 0.20) p < 0.001. The mean Visual Analog Scale (VAS) score of EQ-5D decreased from 72.8 (SD ±15.8) to 48.3 (SD ± 17.2) p < 0.001. All dimensions of EQ-5D showed a significant reduction from the time of pre-fracture status to 1 month after surgery. Independent factors associated with HRQoL 1 month after surgery were pre-fracture status Barthel Index score, Lawton and Brody scale, presence of depression, and type of surgery. After a hip fracture, patients experience considerable deterioration in their HRQoL, especially in self-care, daily activities, and mobility. There is also a significant decline in functional capacity for both the basic and instrumental activities of daily living. One month after surgery, HRQoL is a long way from pre-fracture levels.

Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility Study.

Abstract: Chronic abdominal pain (CAP) can arise from multiple conditions, including inflammatory disorders, trauma because of injury or surgery, or structural or functional causes. This prospective, single-arm study was designed to evaluate the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a 12-month follow-up period. METHODS: Subjects with CAP who had been refractory to conventional medical treatment for at least 3 months resulting in self-reported pain scores of ≥5 cm on a 10-cm visual analog scale were enrolled at 4 centers in the United States. Study subjects underwent a trial stimulation lasting up to 14 days with epidural leads implanted from the vertebral levels T4 through T8. Subjects who had ≥40% pain relief during the trial stimulation period were implanted with a Senza system (Nevro Corp., Redwood City, CA) and followed up to 12 months after surgery.

Experience-Based Swedish TTO and VAS Value Sets for EQ-5D-5L Health States

Abstract: Although value sets for the five-level version of the generic health-related quality-of-life instrument EQ-5D are emerging, there is still no value set available in the literature based on time trade-off valuations made by individuals experiencing the valued health states. The aim of this study was to estimate experience-based value sets for the EQ-5D-5L for Sweden using time trade-off and visual analogue scale valuation methods. In a large, cross-sectional, population-based, self-administered postal health survey, the EQ-5D-5L descriptive system, EQ visual analogue scale and a time trade-off question were included. Time trade-off and visual analogue scale valuations of the respondent’s current health status were used in statistical modelling to estimate a single-index value of health for each of the 3125 health states. Ordinary least-squares and generalised linear models were estimated with the main effect within each of the five dimensions represented by 20 dummy variables reflecting the additional decrement in value for levels 2–5 when the severity increases by one level sequentially beginning from having no problem. Interaction variables representing the occurrence of severity levels in at least one of the dimensions were tested: severity level 2 or worse (N2); severity level 3 or worse (N3); severity level 4 or worse (N4); severity level 5 (N5). A total of 896 health states (28.7% of the 3125 possible EQ-5D-5L health states) were reported by the 25,867 respondents. Visual analogue scale (n = 23,899) and time trade-off (n = 13,381) responders reported valuations of their currently experienced health state. The preferred regression models used ordinary least-squares estimation for both time trade-off and visual analogue scale values and showed consistency in all coefficients after combining certain levels. Levels 4 and 5 for the dimensions of mobility, self-care and usual activities were combined in the time trade-off model. Including the interaction variable N5, indicating severity level 5 in at least one of the five dimensions, made it possible to distinguish between the two worst severity levels where no other dimension is at level 5 as this coefficient is applied only once. In the visual analogue scale regression model, levels 4 and 5 of the mobility dimension were combined. The interaction variables N2–N4 were included, indicating that each of these terms reflect a statistically significant decrement in visual analogue scale value if any of the dimensions is at severity level 2, 3 or 4, respectively. Time trade-off and visual analogue scale value sets for the EQ-5D-5L are now available for Sweden. The time trade-off value set is the first such value set based on experience-based time trade-off valuation. For decision makers with a preference for experience-based valuations of health states from a representative population-based sample, the reported value sets may be considered fit for purpose to support resource allocation decision as well as evaluating population health and healthcare performance.

Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial.

Abstract: Background Adequate pain control after cardiac surgery is essential. Paravertebral block is a simple technique and avoids the potential complications of epidural catheters. The objective of this study is to compare the effect of ultrasound-guided bilateral thoracic paravertebral block with thoracic epidural block on pain control after cardiac surgery. Materials and Methods Between March 2016 and 2017, 145 patients who had cardiac surgery through median sternotomy were randomized by stratified blocked randomization into two groups. Group I (n = 70 patients) had bilateral ultrasound-guided thoracic paravertebral block and Group II (n = 75 patients) had thoracic epidural analgesia. The primary end point was the postoperative visual analogue scale (VAS). The duration of mechanical ventilation, intensive care unit (ICU), and hospital stay were the secondary end points. The study design is a randomized parallel superiority clinical trial. Results Both groups had similar preoperative and operative characteristics. No significant difference in VAS measured immediately after endotracheal extubation then after 12, 24, and 48 hours between groups (p = 0.45). Pain score significantly declined with the repeated measures (p Conclusion This randomized parallel controlled trial demonstrates that ultrasound-guided paravertebral block is safe and effective method for relieving post-cardiac surgery sternotomy pain compared with thoracic epidural analgesia but not superior to it.

Autologous fat grafting efficacy in treating PostMastectomy pain syndrome: A prospective multicenter trial of two Senonetwork Italia breast centers.

Abstract: Postmastectomy pain syndrome (PMPS) represents a common complication following breast surgery defined as a chronic neuropathic pain located in the front of the chest, in the axilla and in the upper arm that for more than 3 months after surgery. Several medications prove to be ineffective while autologous fat grafting revealed to be an innovative solution in the treatment of neuropathic pain syndromes based on retrospective studies. For this reason, we performed a prospective multicenter trial to reduce the memory bias and further increase the evidence of the results. From February 2018 to March 2019, 37 female patients aged between 18 and 80 years, underwent mastectomy or quadrantectomy with pathologic scarring and chronic persistent neuropathic pain, compatible with PMPS, are been included in the study and treated with autologous fat grafting. During the enrollment phase, patients were asked to estimate pain using the Visual Analogue Scale (VAS) and POSAS questionnaire in order to evaluate scar outcomes. The VAS scale, starting from 6.9 (1.3), decreased in the first month by 3.10 (1.59), continuing to fall by 0.83 (1.60) to 3 months and by 0.39 (2.09) at 6 months. Statistical analysis showed a significant reduction after 1 month (P < .0001) and 3 months (P < .005). All POSAS grades documented a statistically significant reduction (P < .0001) of the scores by both observers and patients. We observed that no significant association was found between age, BMI, menopausal status of patients, days from oncologic surgery to autologous fat grafting and reduction of VAS values over time while both smoking and axillary dissection were observed as the main factor significantly associated with a reduced clinical efficacy (respectively, P = .0227 and P = .0066). Our prospective multicenter trial confirms the efficacy of fat grafting in the treatment of PMPS based on the principle of regenerative medicine with a satisfactory response in terms of pain reduction and improvement of the quality of the treated tissues. Clinical questionnaires show that the cicatricial areas improve in terms of color, thickness, skin pliability, and surface irregularities. Regenerative effect is based also on the adoption of needles. The combined effect of fat grafting and needles determines a clinical full response.

Efficacy of Systemic Steroid Use Given One Day After Total Knee Arthroplasty for Pain and Nausea: A Randomized Controlled Study

Abstract: Background Systemic steroid has been used to control pain and nausea in total knee arthroplasty (TKA), but most studies recommend a single dose administration prior to, or during, surgery. This study aimed to determine the efficacy of administration on 1 day postoperatively. Methods Patients who were scheduled to undergo TKA were randomly assigned to the following groups: control group, receiving normal saline injection; group 1, receiving 10 mg dexamethasone intravenously (IV) 1 hour before surgery; group 2, receiving 0.1 mg/kg dexamethasone (IV) 24 hours after surgery; or group 3, receiving 0.2 mg/kg dexamethasone (IV) 24 hours after surgery (n = 44-46 per group). Primary outcomes were pain and nausea visual analogue scale (VAS). Secondary outcomes were analgesic administration, rescue antiemetic administration, C-reactive protein, range of motion, and complications. Results Postoperative pain and nausea remained high for 48 hours post-TKA. Group 1 had lower pain and nausea VAS scores than did the control group (P Conclusion The effect of preoperative and postoperative administration of dexamethasone for controlling pain and nausea was observed only for 24 hours. Considering that severe pain and nausea persisted for more than 48 hours after TKA, additional administration of dexamethasone at 1 day postoperatively is suggested. Level of Evidence Level I.

A randomized controlled trial of 5 daily sessions and continuous trial of 4 weekly sessions of repetitive transcranial magnetic stimulation for neuropathic pain

Abstract: 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 (NP). Patients were randomly assigned to receive 5 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 4 weekly sessions of active rTMS. The primary outcome was a mean decrease in a visual analogue scale 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. One hundred forty-four patients were assigned to the active or sham stimulation groups. The primary outcome, mean visual analogue scale 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 2 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 NP. Long-term administration to the responders should be investigated for the clinical use of rTMS on NP in the future trials.

Changes in quality of life and dyspnoea after hospitalization in COVID-19 patients discharged at home

Abstract: Background To date, the effects of COVID-19 pneumonia on health-related quality of life (HRQoL) and dyspnoea are unknown. Methods In a real-life observational study, 20 patients with COVID-19-related pneumonia received usual care plus erdosteine (300 mg twice daily) for 15 days after hospital discharge following local standard operating procedures. At discharge (T0) and on Day 15 (T1), participants completed the St George's Respiratory Questionnaire (SGRQ), the modified Medical Research Council (mMRC) scale of dyspnoea during daily activity, the BORG scale for dyspnoea during exertion, and Visual Analogue Scale (VAS) for dyspnoea at rest. Paired t-tests compared scores at T0 and T1. Results The mean (SD) SGRQ total score decreased from 25.5 (15.5) at T0 to 16.9 (13.2) at T1 (p<0.01); 65% of patients achieved a clinically important change of ≥4 points. SGRQ domain scores (symptoms, activity, and impact) were also significantly reduced (all p<0.01). The mean (SD) VAS score decreased from 1.6 (1.7) to 1.4 (2.5); p<0.01. The mean mMRC score decreased significantly (p=0.031) and 30% of patients achieved a clinically important change of ≥1 point. The mean (SD) Borg score increased from 12.8 (4.2) to 14.3 (2.4); p<0.01. Conclusion The present proof of concept study is the first to report HRQoL in patients with COVID-19. During 15 days after hospital discharge, patients reported significant improvements in HRQoL and dyspnoea at rest and during daily activities.

The Efficiency of Platelet Rich Plasma Treatment in patients with knee osteoarthritis.

Abstract: OBJECTIVE The aim of this study was to determine the effects of platelet-rich plasma (PRP) treatment on pain, functionality, quality of life, and cartilage thickness in patients with knee osteoarthritis (OA). METHODS Sixty patients with chronic knee pain were randomly separated into two groups. The first group was administered 4-ml PRP intra-articularly (IA) in three doses at one-week intervals, and the second group had only one dose of a 4-ml saline solution IA. The patients' pain was measured using the Visual Analogue Scale (VAS); functionality was measured using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC). The distal femur cartilage thickness was assessed using ultrasonography (USG). RESULTS All baseline parameters were similar (p> 0.05). In the first and sixth months after the treatment, the VAS scores of the PRP group were significantly low (p< 0.001). In the same group, only the pain sub-score was low in the WOMAC assessment in the first month after treatment. However, in the sixth month, all parameters of the WOMAC score were lower than those of the placebo group (p< 0.05). Cartilage thickness measurements were similar in the two groups (p< 0.05). CONCLUSION PRP treatment had positive effects on the pain, physical function, and quality of life of patients with knee OA, but it did not increase cartilage thickness.

Correlation between work impairment, scores of rhinitis severity and asthma using the MASK-air® App

Abstract: Background: In allergic rhinitis, a relevant outcome providing information on the effectiveness of interventions is needed. In MASK‐air (Mobile Airways Sentinel Network), a visual analogue scale (VAS) for work is used as a relevant outcome. This study aimed to assess the performance of the work VAS work by comparing VAS work with other VAS measurements and symptom‐medication scores obtained concurrently. Methods: All consecutive MASK‐air users in 23 countries from 1 June 2016 to 31 October 2018 were included (14 189 users; 205 904 days). Geolocalized users self‐assessed daily symptom control using the touchscreen functionality on their smart phone to click on VAS scores (ranging from 0 to 100) for overall symptoms (global), nose, eyes, asthma and work. Two symptom‐medication scores were used: the modified EAACI CSMS score and the MASK control score for rhinitis. To assess data quality, the intra‐individual response variability (IRV) index was calculated. Results: A strong correlation was observed between VAS work and other VAS. The highest levels for correlation with VAS work and variance explained in VAS work were found with VAS global, followed by VAS nose, eye and asthma. In comparison with VAS global, the mCSMS and MASK control score showed a lower correlation with VAS work. Results are unlikely to be explained by a low quality of data arising from repeated VAS measures. Conclusions: VAS work correlates with other outcomes (VAS global, nose, eye and asthma) but less well with a symptom‐medication score. VAS work should be considered as a potentially useful AR outcome in intervention studies.

How much change in pain score does really matter to patients

Abstract: Objective The goal of this study was to determine the minimal change in pain score recognized by patients as meaningful known as minimal clinically important difference (MCID). Methods Pain was recorded upon admission, 30 and 60 min later and patients were asked to describe the extent of pain change on a 5-point Likert scale ranging from “much better” to “much worse”. Patients reported their pain by two common pain scales comprising numeric rating scale (NRS) and visual analog scale (VAS). We used receiver operating characteristic curve to assess the accuracy of pain scales. We then calculated the mean change in pain scores among patients who reported their pain change as “a little better” or “a little worse” and also analyzed regression to evaluate the MCID. Results A total of 150 patients and 253 pain changes were recruited. The MCID ± SD (95% CI) was 1.65 ± 1.58 (1.32–1.97) for NRS and 16.55 ± 17.53 (12.96–20.15) for VAS. The area under the curve by NRS and VAS were 0.86 and 0.89. For linear regression, the line slope and the y-intercept were 17.56 and 1.88, for VAS; these values were 1.73 and 0.31 for NRS, respectively. Conclusions Recognizing the extent of change in pain score that really matters to patients is crucial for the evaluation of treatment effect. Patients perceived a change of 1.65 points on NRS and 16.55 on VAS in their pain severity as meaningful. This value was not different whether the pain was perceived alleviated or aggravated.

Effectiveness of a Mobile eHealth App in Guiding Patients in Pain Control and Opiate Use After Total Knee Replacement: Randomized Controlled Trial.

Abstract: Background: Little is known about pain and opiate use at home directly after total knee replacement (TKR). Due to adverse effects, low opiate use is desired. An electronic health app (PainCoach) was developed to guide patients in pain control and opiate use. Objective: The aim of this paper was to investigate the effects of the PainCoach app on pain control and opiate use in patients who underwent TKR during the first 2 weeks at home after surgery. Methods: In an unblinded randomized controlled trial, patients scheduled for TKR were offline recruited and randomized to a PainCoach group or control group. In the PainCoach group, the PainCoach app was downloaded on each patient’s smartphone or tablet. In response to the patient’s input of the pain experienced, the PainCoach app gave advice on pain medication use, exercises/rest, and when to call the clinic. This advice was the same as that received during usual care. The control group received usual care. The primary outcomes were opiate use and visual analog scale (VAS) pain scores at rest, during activity, and at night during the first 2 weeks at home after surgery, which were collected daily from day 1 until 14 postoperatively by online questionnaires. The actual amount of app use was recorded, and active use was defined as ≥12 total app uses. Results: The pain scores did not differ between the groups. The PainCoach group (n=38) used 23.2% less opiates (95% CI −38.3 to −4.4; P=.02) and 14.6% more acetaminophen (95% CI 8.2-21.3; P<.001) when compared with the findings in the control group (n=33). The PainCoach app was used 12 (IQR 4.5-22.0) times per patient. In the active PainCoach subgroup (n=19), the following were noted when compared with the findings in the control group: 4.1 times faster reduction of the VAS pain score during activity (95% CI −7.5 to −0.8; P=.02), 6.3 times faster reduction of the VAS pain score at night (95% CI −10.1 to −2.6; P=.001), 44.3% less opiate use (95% CI −59.4 to −23.5; P<.001), 76.3% less gabapentin use (95% CI −86.0 to −59.8; P<.001), and 21.0% more acetaminophen use (95% CI 12.6-30.0; P<.001). Conclusions: The use of the PainCoach app contributes to reduced opiate use in the initial period at home after TKR. Active use of this app leads to a further reduction in opiate use and improved pain control. Trial Registration: ClinicalTrials.gov NCT03961152; https://clinicaltrials.gov/ct2/show/NCT03961152