Included Pain Visual Analogue Scale Research Articles

Allogenic bone marrow–derived mesenchymal stromal cell–based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study)

ObjectivesTo assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).MethodsParticipants were...

The impact of different timing of mouth opening exercises on trismus in postoperative radiotherapy patients with oral cancer

ObjectiveTo compare the effects of starting mouth opening exercises at two different times on trismus in postoperative radiotherapy patients with oral cancer. MethodsThrough a prospective randomized controlled trial, purposive sampling was used to select 76 patients undergoing postoperative radiotherapy for oral cancer from March 2023 to January 2024 at the Department of Oral and Maxillofacial Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. Patients were randomly divided into an experimental group (n = 38) and a control group (n = 38) using a random number table at a ratio of 1:1. The experimental group began mouth opening exercises in the second week after surgery (before radiotherapy), while the control group began in the fourth week after surgery (at the start of radiotherapy). The primary outcome measure was maximum interincisal opening (MIO). Secondary outcome measures included pain visual analog scale (VAS) scores and quality of life scores (UW-QOL), assessed at baseline, the second week post-surgery (before radiotherapy), the fourth week post-surgery (at the start of radiotherapy), the ninth week post-surgery (end of radiotherapy), and the twelfth week post-surgery (three weeks after the end of radiotherapy). ResultsA total of 72 patients completed all assessments, with 36 in each group, resulting in an overall sample attrition rate of 5.26 % (less than 15 %). There were no statistically significant differences in general demographic and clinical characteristics between the two groups. Repeated measures ANOVA showed significant differences in MIO, VAS, and UW-QOL scores between groups, over time, and in group-time interactions (P < 0.001). From the fourth week post-surgery (at the start of radiotherapy), the experimental group had significantly higher MIO (P < 0.001), significantly lower VAS scores (P < 0.001), and significantly higher UW-QOL scores (P < 0.001) compared to the control group. These differences persisted at subsequent assessment points. ConclusionInitiating mouth opening exercises in the second week post-surgery (before radiotherapy) can significantly improve mouth opening, reduce pain, and enhance the quality of life in postoperative radiotherapy patients with oral cancer. This provides important evidence for clinical practice, although further research is needed to verify the long-term effects.

Novel MRI-Based Pedicle Bone Quality Score Independently Predicts Pedicle Screw Loosening after Degenerative Lumbar Fusion Surgery.

To introduce and evaluate an MRI-based PBQ score to determine its effectiveness in predicting pedicle screw loosening following lumbar fusion surgery. The retrospective study analyzed 244 patients who underwent posterior lumbar interbody fusion (PLIF) with pedicle screws between December 2017 and December 2021, with CT and MRI imaging before surgery. Data collected included patient demographics and preoperative radiological data. Radiographic screw loosening was measured at 12 months postoperatively. Clinical assessments included pain visual analog scale (VAS) and Oswestry Disability Index (ODI) scores. The PBQ score was measured using MRI scans. We use univariate analysis for preliminary screening of the risk factors of screw loosening. Subsequent analysis involved multivariate logistic regression to identify independent predictive factors for screw loosening. We constructed the receiver operating characteristic (ROC) curve to ascertain the discriminative capacity of the PBQ score. The area under the curve (AUC) quantified its predictive accuracy. Additionally, we evaluated the association between PBQ score and screw loosening using Spearman's correlation analysis. Overall, 244 patients who underwent PLIF with pedicle screw fixation participated in this study, including 35 in the loosening group and 209 in the non-loosening group. PBQ score in the loosening group was significantly higher than that in the non-loosening group. On multivariate logistic regression, the higher PBQ score (OR = 8.481, 95% CI: 3.158-22.774; p < 0.001) and the lower mean Hounsfield unit (HU) value of L1-4 (OR = 0.967, 95% CI 0.951-0.984; p < 0.001) were the variables that significantly predicted screw loosening. The AUC for the PBQ score and HU value were 0.751 (95% CI: 0.673-0.828) and 0.702 (95% CI: 0.612-0.791). The PBQ score optimal cutoff to differentiate patients with loosening and with non-loosening was calculated as 3.045 with a sensitivity of 85.7% and specificity of 76.9%, while the optimal cutoff of the HU value was 151.5 with a sensitivity of 64.6% and specificity of 89.5%. The association between the PBQ score and the propensity for lumbar pedicle screw loosening was found to be substantial. As a predictive measure, the PBQ score outperformed the HU value in forecasting the likelihood of screw loosening post-posterior lumbar fusion.

A threshold of lower preoperative mental health is associated with decreased achievement of comfort and capability benchmarks following rotator cuff repair: a retrospective cohort study

Preoperative biomedical patient characteristics are known to affect the time to achievement of clinically significant outcomes (CSOs) following arthroscopic rotator cuff repair (RCR). However, less is known about the association between preoperative mental status and the time to achievement of CSOs. We hypothesize that higher preoperative mental status is associated with faster achievement of CSOs following arthroscopic RCR. Patient-reported outcome measures (PROMs) were collected preoperatively and at postoperative intervals up to 2 years. PROMs included pain visual analog scale (VAS), American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Single Assessment Numeric Evaluation (SANE), and Veterans RAND 12-Item Health Survey (VR-12) scores. Threshold values for CSOs were obtained from previous literature. Mean time to achievement of CSOs was calculated using a Kaplan-Meier analysis. A Cox proportional hazards regression analysis was performed to identify preoperative variables associated with earlier achievement of CSOs. Sixty-nine patients with an average age of 59±8 years were included. Patients with higher preoperative mental status, as measured by VR-12 mental component summary (MCS), experienced significantly earlier substantial pain improvement postoperatively (P=.0471). Patients with higher preoperative mental status also achieved CSOs for physical health at earlier time points (P=.0187). Preoperative VR-12 MCS scores ≥ 40 were associated with earlier achievement of CSOs for pain (P=.0005) and physical health (P=.0015). Ninety-eight percent of patients with preoperative MCS scores ≥40 achieved acceptable pain relief at 4.5 months vs. 56% of all other patients at 12.3 months (P=.0001). Patients with preoperative MCS scores ≥40 experienced significantly faster improvement in physical health compared to patients with preoperative MCS scores <40 (P=.0006). Higher preoperative mental status, especially a preoperative MCS score ≥40, is associated with significantly faster improvement in pain and physical function following arthroscopic RCR. Nearly all patients (98%) with preoperative MCS score ≥40 achieved an acceptable state of pain relief compared with only 56% of patients with preoperative MCS score <40. These findings indicate that a holistic approach with equal consideration of preoperative mental health and rotator cuff pathophysiology is vital to the successful management of rotator cuff tendinopathy.

Biceps Rerouting Regardless of a Biceps-Labral Lesion During Rotator Cuff Repair Results in Lower Retear Rates and Comparable Clinical Outcomes to Subpectoral Biceps Tenodesis

PurposeTo evaluate the radiographic and clinical outcomes when rerouting a pathologic biceps during arthroscopic rotator cuff repair, by comparing it with concomitant subpectoral biceps tenodesis. MethodsThis retrospective, historical cohort study was conducted with patients who underwent an arthroscopic repair of a full-thickness rotator cuff tear, with intraoperative confirmation of biceps pathology including partial tears, subluxation, pulley lesions, or type II superior labrum anterior to posterior (SLAP) lesions. Until May 2018, such patients were treated with concomitant subpectoral tenodesis (group SPBT). Afterward, biceps rerouting was done regardless of biceps pathology (group BR) without biceps or SLAP repair. Radiographic parameters, including fatty degeneration, acromiohumeral distance, Sugaya classification, and retears, were evaluated using preoperative and one-year postoperative MRI. Clinical evaluation with a minimum two-year follow-up included pain visual analogue scale, American Shoulder and Elbow Surgeons, Simple Shoulder Test, and Constant-Murley scores. Whether individual patients exceeded these scores' minimal clinically important difference was also determined. ResultsA total of 64 patients (group SPBT, 32; group BR, 32) were included in the final analysis. The duration of clinical follow-up was 36.2 ± 9.3 months in group SPBT and 29.4 ± 6.9 months in the BR group (P=0.002). Compared to group SPBT, group BR demonstrated a significantly lower retear rate (SPBT vs. BR: 34.4% vs. 12.5%, P=0.039). In the BR group, 8/32 (25%) patients demonstrated a postoperative LHBT tear. The four cuff retears in group BR only took place within these patients. Other postoperative radiographic and clinical outcomes were comparable between the groups. Within each group, significant postoperative improvements were demonstrated (P<0.05 for all clinical scores). ConclusionEven in the presence of a pathologic LHBT and/or a type II SLAP lesion, augmenting the rotator cuff repair with BR significantly reduced retear rates while achieving clinical scores comparable to SPBT in a minimum two-year follow-up.

Early postoperative recovery comparisons of superior capsule reconstruction to tendon transfers.

The management of massive posterosuperior rotator cuff tears is controversial, with no gold standard. Two recently developed techniques that have shown promising initial results include arthroscopic superior capsular reconstruction (SCR) and tendon transfers (latissimus or lower trapezius). However, there remains a scarcity of studies examining each procedure's early postoperative clinical outcomes individually or in comparison to each other. The purpose of this study is to compare the early postoperative recovery outcomes of tendon transfers (TTs) to SCR. Using the surgical outcomes system global database (Arthrex Inc.), we assessed the postoperative recovery outcomes for all patients who had outcomes recorded at least 6 months after SCR or TT. The time points analyzed included preoperative and postoperative (2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years). The outcomes analyzed included pain visual analog scale (VAS) score, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score, VR-12 physical, and Single Assessment Numeric Evaluation (SANE). Overall, 163 patients underwent SCR and 24 arthroscopically assisted TT. The mean age for SCR and TT was 60 and 56 years, respectively. Postoperative recovery curves demonstrate that both procedures produced improved outcomes at each postoperative time point compared to preoperative. The pain and functional outcomes measures, including VAS, ASES, SANE, and VR-12 physical, were comparable for TT and SCRs, with similar recovery curves between the 2 techniques. Ultimately at 2 years postoperatively, there were no significant differences between the 2 techniques. Analysis of the early outcomes associated with arthroscopic treatment of massive posterosuperior rotator cuff tears demonstrated that the arthroscopically assisted tendon transfers and arthroscopic superior capsular reconstruction had similar pain and functional outcomes throughout the 2-year postoperative recovery period. Overall, the process of recovery appears equivalent between the 2 techniques. Future studies are needed to assess the outcomes of each technique and specific indications in an attempt to delineate an algorithm for the treatment of irreparable rotator cuff tears.

Clinical Observation on Therapeutic Effect of Electroacupuncture Combined with Diclofenac Sodium in Treatment of Acute Gouty Arthritis: A Randomized Controlled Study.

Objective To observe the clinical effect of electroacupuncture (EA) combined with diclofenac sodium (DS) in the treatment of acute gouty arthritis (AGA). Methods Patients with AGA were randomly divided into three groups: the EA + DS treatment group (i.e., EA + DS group), the low-dose DS treatment group (i.e., low-dose DS group), and the conventional-dose DS treatment group (i. e., conventional DS group). Patients in the low-dose DS group took 50 mg of DS sustained-release capsules once a day. Patients in the conventional DS group took 100 mg of DS sustained-release capsules once a day. Patients in the EA + DS group were treated with EA three times in 7 days combined with 50 mg of DS sustained-release capsules once a day. For all the three groups, 7 days were regarded as a course of treatment. Outcome indicators included pain visual analog scale (VAS), joint tenderness, joint swelling and activity limitation, and levels of inflammatory indicators (C-reactive protein (CRP)/white blood cells (WBC)/percentage of neutrophils (NE%)), level of serum uric acid (SUA), gout impact scale (GIS), and frequency of adverse reactions). Results After a course of treatment, indicators regarding the VAS, joint tenderness, joint swelling, activity limitation, GIS, inflammatory indicators (CRP/WBC/NE%), and SUA were all improved (P < 0.05) with no adverse reactions in the EA + DS group. The EA + DS group performed better than the low-dose DS group in improving indicators regarding the VAS, joint tenderness, activity limitation, GIS, inflammatory markers (WBC/NE%), and SUA (P < 0.05). Similarly, the EA + DS group performed better than the conventional DS group in improving indicators regarding GIS, SUA, and adverse reactions (P < 0.05). Conclusion EA combined with DS can improve AGA patients' joint pain and functional status, thus improving their quality of life. Moreover, this combined treatment can reduce the levels of inflammatory markers and SUA, leading to fewer adverse reactions in AGA patients.

Juvenile Fibromyalgia in Patients With Juvenile Idiopathic Arthritis: Utility of the Pain and Symptom Assessment Tool.

To evaluate the proportion of children with juvenile idiopathic arthritis (JIA) who met criteria for comorbid juvenile fibromyalgia (FM) using the Pain and Symptom Assessment Tool (PSAT), and to identify clinical and demographic differences among JIA patients with and without juvenile FM. Patients ages 11-17 years with JIA were recruited from 4 North American pediatric rheumatology centers. Each patient completed the PSAT. Additional clinical and disease activity measures included pain visual analog scale, patient global assessment of disease activity (PtGA) and physician global assessment of disease activity (PhGA), the Functional Disability Inventory (FDI), and the Pain Catastrophizing Scale in children. Of 129 patients, 11 met criteria for juvenile FM. FDI scores were markedly higher in patients who tested positive for juvenile FM, with a mean of 24.8 compared to 6.9 in patients without juvenile FM (P < 0.001). Pain catastrophizing scores were also significantly higher, by ~14 points, in patients with juvenile FM. There was a significant tendency for patients to give higher disease activity scores than physicians, which was more marked among patients with juvenile FM. In patients with juvenile FM, PtGA scores exceeded PhGA scores by a mean of 3.7, compared to a mean of 0.7 among patients without juvenile FM (P < 0.001). A minority of JIA patients (8.5%) met criteria for juvenile FM. This group demonstrated markedly more functional impairment. PtGA scores were strikingly higher than PhGA scores among patients with JIA who met juvenile FM criteria, suggesting that providers might consider a more expansive approach to chronic pain and non-musculoskeletal symptom assessment and treatment in JIA patients.

Efficiency and Safety of Erector Spinae Plane Block in Percutaneous Nephrolithotomy: A Meta-Analysis Based on Randomized Controlled Trials

To pool the data of published studies using the meta-analysis method to provide high-level evidence for the use of ESPB in pain control after PCNL. Two main stream databases, Pubmed and Embase, were used to identify potentially included studies. Primary outcomes included pain visual analogue scale (VAS) at different time points, intraoperative fentanyl use, time to first rescue analgesia and total tramadol or paracetamol consumption. Secondary outcome was defined as side effects of nausea and vomiting. Fourteen studies were identified after database searching and 6 studies were included in the quantitative analysis. Overall, ESPB could significantly reduce the postoperative short-time (1-2 hours) and long-time (24 hours) VAS values (MD: -1.35, 95%CI: -1.71, -1.00 for short-time and MD: -0.39, 95%CI: -0.61, -0.17 for long-time) without significant heterogeneity. When it came to other primary outcomes, ESPB still showed its advantages in less intraoperative fentanyl use and total tramadol/paracetamol consumption, and longer time to first rescue analgesia. Complications were similar between groups (OR:0.90, 95%CI:0.38-2.14). ESPB was an efficient and safe procedure for postoperative pain management in PCNL. More RCTs with larger sample size are still needed.

Outcomes of arthroscopic-assisted middle trapezius tendon transfer for isolated irreparable supraspinatus tendon tears: minimum 2-year follow-up.

Middle trapezius tendon (MTT) transfer has been proposed as a feasible option for managing isolated irreparable supraspinatus tears (IISTTs). However, no clinical study has been attempted. This study aimed to evaluate clinical and radiologic outcomes of arthroscopic-assisted MTT transfer in patients with IISTTs. This retrospective study included patients who underwent arthroscopic-assisted MTT transfer using fascia lata autograft for IISTTs. Clinical outcomes, including pain visual analog scale (VAS), Constant, American Shoulder and Elbow Society (ASES), University of California Los Angeles (UCLA) shoulder scores and active range of motion (aROM), were assessed. Radiographic analyses included the acromiohumeral distance (AHD), Hamada grade, and transferred tendon integrity at the final follow-up. Twenty-two patients (mean age: 63.3 ± 6.8 [51‒74] years; mean follow-up period: 28.9 ± 4.9 [24‒44] months) met the study criteria. The mean VAS, Constant, ASES, and UCLA scores improved postoperatively at the final follow-up (p < 0.001). The mean aROMs for forward flexion and abduction were significantly increased postoperatively. No significant changes of AHD (p = 0.105) and Hamada grade (p = 0.815) were observed postoperatively. One patient had a re-tear of the transferred tendon at the footprint site at the final follow-up. In this minimum 2-year follow-up study of the novel aMTT transfer using fascia lata autograft, we found significant improvement in pain relief, clinical scores, and active forward flexion and abduction. Additionally, no significant progression of cuff tear arthropathy was observed at the final follow-up. Therefore, aMTT transfer could be a promising treatment option for patients with IISTTs. However, further multicenter and long-term trials are needed to verify its effectiveness. Retrospective case series, level IV.

The effects of acupuncture and related techniques on patients with rheumatoid arthritis: A systematic review and meta-analysis.

One new type of acupuncture and related techniques (ACNRT) is increasingly used by rheumatoid arthritis (RA) patients to control their disease and improve their quality of life. However, the efficacy of using ACNRT in combination with western medicine (WM) for this purpose remains unknown. Randomized controlled trials of ACNRT and WM treatments for RA from January 1, 2000, to January 31, 2021, were searched for in the databases PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials, as well as in three Chinese databases: China National Knowledge Infrastructure, Wanfang Data, and Airiti Library. The primary outcomes consisted of inflammatory markers including C reactive protein (CRP), erythrocyte sedimentation rate (ESR), and rheumatoid factor. The secondary outcomes were clinical characteristics including pain visual analog scale (VAS) score, Disease Activity Score (DAS-28), swollen joints count (SJC), tender joints count (TJC), morning stiffness, and the results of a health assessment questionnaire. The three types of ACNRT used in the focal trials were acupuncture, moxibustion, and electro-acupuncture. Two qualified researchers extracted data from these trials' results and independently assessed their risk of bias. Statistical analyses were performed using Comprehensive Meta-Analysis V3 software. A total of 12 RCTs with 874 patients met the inclusion criteria. As compared with the patients who received WM treatment alone, those who were given integrated ACNRT/WM treatment showed greater reductions in CRP (weighted mean difference [WMD]: -6.299; 95% CI: -9.082 to -3.517), ESR (WMD: -6.563; 95% CI: -8.604 to -4.522), VAS (WMD: -1.089; 95% CI: -1.575 to -0.602), DAS-28 (WMD: -0.633; 95% CI: -1.006 to -0.259), SJC (WMD: -1.921; 95% CI: -3.635 to -0.207), and TJC (WMD: -1.491; 95% CI: -2.941 to -0.042). This meta-analysis of RA provides reliable evidence in favor of ACNRT plus WM. However, longer term, high-quality, repeatable, multicenter randomized controlled trials with larger sample sizes are needed.

Maintenance of Patient-Reported Outcomes in Baricitinib-Treated Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Post Hoc Analyses from Two Phase 3 Trials.

IntroductionBaricitinib has been shown to improve patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) who are inadequate responders (IR) to conventional synthetic and biologic disease-modifying antirheumatic drugs (csDMARDs and bDMARDs, respectively). We assessed the ability of baricitinib 2-mg to maintain minimal clinically important differences (MCIDs) in PROs until week 24 among week 4 and 12 responders.MethodsData were from two phase 3 trials, RA-BUILD (NCT01721057; csDMARD-IR patients) and RA-BEACON (NCT01721044; bDMARD-IR patients). PROs included Pain Visual Analogue Scale, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue, Short-Form 36 Physical Component Score, and Patient’s Global Assessment of Disease Activity. Outcomes were evaluated by proportions of patients achieving MCID improvements, number needed to treat (NNT) at weeks 4, 12, and 24, proportions of patients maintaining MCID responses at week 24 among week 4 or 12 responders, and median time to achieve substantial response with baricitinib 2-mg versus placebo.ResultsA higher proportion of baricitinib-treated patients achieved MCID improvements, with NNTs ranging from 5 to 8 for baricitinib 2-mg versus placebo at week 24. Generally, early MCID responses in PROs at weeks 4 or 12 were better maintained through week 24 in RA patients treated with baricitinib 2-mg versus placebo. Patients treated with baricitinib 2-mg also achieved substantial PRO responses or normative values more quickly than placebo.ConclusionsThese results suggest baricitinib-treated patients with RA achieving MCID improvement in PROs at weeks 4 and 12 maintained those improvements over time and that substantial PRO responses were achieved quickly.

Association between clinical parameters and size of three-dimensionally reconstructed anatomical abnormalities in patients with lateral epicondylitis: a cross-sectional study

BackgroundThe association of the severity of clinical symptoms and level of functional performance with the degree of magnetic resonance imaging abnormalities in patients with lateral epicondylitis has not been fully elucidated. This study aimed to investigate the association between the degree of anatomical abnormalities by evaluating three-dimensional magnetic resonance imaging models of the common extensor tendon and clinical parameters in patients with lateral epicondylitis.Materials and methodsA total of 61 patients (24 men and 37 women) with lateral epicondylitis were included in this study. 3-Tesla magnetic resonance imaging was performed for all patients, and clinical parameters, including pain visual analog scale score, Quick Disabilities of Arm, Shoulder and Hand questionnaire score, elbow range of motion, and demographic factors, were evaluated. The proportion of lesion volume of common extensor tendon was adopted for three-dimensional model analysis. To determine the factors associated with clinical parameters, univariate, and multivariate linear regression analyses were performed.ResultsThe proportion of lesion volume of common extensor tendon was not associated with clinical parameters. Gender and muscle edema were independently associated with pain visual analog scale scores. However, demographic factors and magnetic resonance imaging abnormalities were not associated with the Quick Disabilities of Arm, Shoulder, and Hand questionnaire score or elbow range of motion.ConclusionsThe three-dimensional volumetric lesion size of common extensor tendon was not associated with clinical symptoms and functional performance in patients with lateral epicondylitis. The clinical parameters of lateral epicondylitis may be influenced by several factors.

Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy

Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated. Implanted medical device delivering 10-kHz SCS. The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months. Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001). Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN. ClincalTrials.gov Identifier: NCT03228420.

AB0773 THE INCIDENCE OF RESIDUAL DISEASE ACTIVITY FOLLOWING DIVERSE DISEASE ACTIVITY MEASUREMENTS FOR PSORIATIC ARTHRITIS

Background:Due to the complex nature of psoriatic arthritis (PsA), diverse disease activity measures have been developed, the most common of which include Disease Activity Score for Psoriatic Arthritis (DAPSA), Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA). Recently, new composite measures have been developed such as Psoriatic Arthritis Disease Activity Score (PASDAS) and GRACE index. Due to different domains and assessments, even though these measures may indicate remission or low disease activity, residual disease activity (RDA) may persist.Objectives:The aim of this study was to evaluate RDA in patients with PsA.Methods:A total of 148 patients (105 female, 43 male; mean age 47.5 (SD:12.6) years) who met the CASPAR criteria for PsA were recruited. Demographic and clinical characteristics of patients were recorded, including pain visual analog scale (VAS), joint VAS, patient global VAS, and tender and swollen joint counts. Evaluations included the Leeds Enthesitis Index (LEI), Psoriasis Area and Severity Index (PASI), Psoriatic Arthritis Quality of Life (PsAQoL), Short-Form 36 Health Survey (SF-36) and Health Assesment Questionnaire (HAQ). Disease activity and remission were assessed using the DAPSA, MDA, VLDA, PASDAS and GRACE Index. MDA was calculated with 5 and 6 positivity criteria separately. Low disease activity (LDA) was defined as follows: DAPSA≤14, PASDAS≤3.2 and GRACE Index≤2.3. RDA was defined as the presence of at least one of the following criteria despite remission or LDA: tender and/or swollen joints &gt;1, dactilitis &gt;1, LEI&gt;1, HAQ&gt;0.5, PASI&gt;1, PtGA&gt;20, physician VAS&gt;20, or pain VAS&gt;15.Results:The mean duration of disease was 68.2 (SD:80.2) months. DAPSA-LDA, PASDAS-LDA, GRACE-LDA, MDA and VLDA were observed in 48.6%, 14.6%, 14.9%, 23.6% and 2% of PsA patients, respectively. RDA as determined by at least one domain was identified in 91%, 95%, 86% and 86% of patients who were classified as having MDA, DAPSA-LDA, PASDAS-LDA and GRACE-LDA, respectively. Undetected RDA was most common with DAPSA, whereas VLDA completely ruled out RDA. PASDAS and GRACE resulted in similar rates of RDA (Table-1). With DAPSA-LDA, the incidence of RDA in the pain domain was significantly lower with older age. Female patients had higher rates of RDA with the LEI and HAQ (p&lt;0.05).Conclusion:VLDA was the most and DAPSA was the least sensitive method to detect remission/LDA. RDA should be kept in mind in patients with PsA when using current measures to assess remission or LDA.

A prospective study of persistent postsurgical pain at 1 year after total knee arthroplasty in a Japanese tertiary hospital

Purpose: Total knee arthroplasty (TKA) is one of the most common and successful orthopaedic surgeries performed throughout the world. Although good pain relief can be achieved with TKA, significant proportion of patients experience persistent postsurgical pain (PPSP). A systematic review of recent studies from Europe and United States showed that 10-34% of patients complain of PPSP. However, since no prospective studies have ever been conducted in Japan, the prevalence of PPSP in the Japanese population is unknown. The aim of this prospective study was to elucidate the prevalence and preoperative risk factors of PPSP after TKA in a Japanese tertiary hospital. Methods: Between April 2012 to March 2018, patients were recruited in a Japanese tertiary hospital. Four hundred twenty-six TKAs were performed in patients during the period. Two hundred eighty-eight patients underwent unilateral TKA while 30 patients underwent simultaneous bilateral TKA. Preoperative diagnosis was osteoarthritis in 394 knees, rheumatoid arthritis in 28 knees, and osteonecrosis in 4 knees. Exclusion criteria were as follows: dementia, symptomatic venous thrombosis, periprosthetic join infection, and mal-positioned TKA (≧3 degrees error in sagittal and/or coronal plane). Preoperative evaluation included pain visual analog scale (VAS) at rest and at walk, WOMAC, Knee Society Score (KSS), EQ-5D, pain catastrophizing scale, pain DETECT. All TKA were performed under both general anesthesia and ultrasound-guided femoral nerve block. Postoperative pain was evaluated using a 100mm VAS. Patients were instructed to express their pain around the replaced knee while rest and walking during the past week by putting a mark on the 100mm VAS by themselves. PPSP was defined as a VAS score of >30 while walking at 1 year follow up. The prevalence of PPSP was calculated from patients followed at 1 year after surgery. The preoperative risk factors for PPSP were analyzed from patients who completed preoperative questionnaires. Statistical comparison between with and without PPSP was analyzed by Mann-Whitney U test and Chi-squared test. To determine the risk factors for PPSP, logistic regression analysis was used from among those factors which had significant difference (p<0.05) in univariate analysis. Results: Of 318 patients who underwent TKA, 346 knees of 254 patients were followed at 1 year after surgery. The prevalence of PPSP was 8.4% (19 of 346 knees). Two hundred and forty-six knees of 190 patients completed preoperative questionnaires. The mean age at surgery was 74 years old (range 43-90). Univariate analysis showed that patients with PPSP had significantly higher VAS at rest, WOMAC pain score, WOMAC stiffness score, WOMAC function score, WOMAC total score and lower EQ-5D compared with those without. Logistic regression analysis showed that WOMAC function score significantly affected PPSP (odds ratio = 1.078, 95% confidence interval 1.035-1.123). Conclusions: The rate of persistent pain was 8.4%. This result is lower than past reports from Europe and United States. In our department, surgeons basically take postoperative follow by themselves at 6 weeks, 3, 6, 12 months after surgery and every year. When we find patients who have something wrong around the replaced knee, we diagnose what is going on and treat appropriately. For example, we treated with steroid injection for infrapatellar saphenous neuralgia and pregabalin medication for lumber radiculopathy at some point. Recent studies have found that PPSP is associated with preoperative knee pain, younger patient, catastrophizing and mental health, while our findings showed the predictive factor of PPSP was WOMAC function score. This is the first report of prospective study for PPSP after TKA in Japan.Table 1.Comparison between patients with and without PPSP.PPSP (-) n=224 kneesPPSP (+) n=22 kneesP valueAge at surgery (years)73 [68-79]76 [72.5-79]0.116Sex (men/women)52 / 1723 / 190.304VAS at rest (mm)20 [5-40]30 [11.3-70]0.045VAS at walk (mm)20 [50-80]70 [54.8-80]0.295WOMAC pain9 [7-11]12 [10-13]0.001WOMAC stiffness5 [4-6]6 [4.3-6]0.036WOMAC function29 [20-39]41 [36.5-49]<0.001WOMAC total44 [32-56]60.5 [52.3-67.3]<0.001KSS knee score50 [39-61]50 [45-60]0.074KSS function score50 [45-60]45 [45-60]0.999EQ-5D0.631 [0.536-0.649]0.562 [0.495-0.596]0.002PCS27 [18.5-32]29.5 [18.8-33]0.243painDETECT10 [6-14]8 [7-16.5]0.946Data are median [IQR]. Statistical comparison between with and without PPSP was analyzed by Mann-Whitney U test and Chi-squared test. Open table in a new tab Data are median [IQR]. Statistical comparison between with and without PPSP was analyzed by Mann-Whitney U test and Chi-squared test.

Physiotherapy Approach in Improving Knee Function Following Total Knee Replacement: A Case Report

Total knee replacement (TKR) is the most commonly performed joint replacement surgery for osteoarthritis. Following TKR, patient is recommended to undergo an intensive rehabilitation to restore knee function (strength and mobility) and regain normal daily routines. This case report presented a physiotherapy approach in the early phase of rehabilitation following TKR. The patient presented with knee pain, swelling, muscle weakness and limited range of motion. Her interventions included pain relief, exercise therapy, patient education and home exercise program. The outcome measures used to evaluate her progression included pain visual analogue scale, goniometry, manual muscle testing and the time up and go test. The patient began to show positive improvement at the third physiotherapy.

Physiotherapy Approach in Improving Knee Function Following Total Knee Replacement: A Case Report

Total knee replacement (TKR) is the most commonly performed joint replacement surgery for osteoarthritis. Following TKR, patient is recommended to undergo an intensive rehabilitation to restore knee function (strength and mobility) and regain normal daily routines. This case report presented a physiotherapy approach in the early phase of rehabilitation following TKR. The patient presented with knee pain, swelling, muscle weakness and limited range of motion. Her interventions included pain relief, exercise therapy, patient education and home exercise program. The outcome measures used to evaluate her progression included pain visual analogue scale, goniometry, manual muscle testing and the time up and go test. The patient began to show positive improvement at the third physiotherapy.

Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy

Medial opening wedge high tibial osteotomy (HTO) entails extensive soft tissue release that may lead to substantial perioperative bleeding. Although tranexamic acid (TXA) is a well-established blood-conserving agent in total joint arthroplasty, its potential to reduce blood loss in patients undergoing HTO has not been studied extensively. (1) Does TXA reduce total estimated blood loss in HTO? (2) Does TXA use in HTO affect in-hospital endpoints as measured by visual analog scale (VAS) pain scores at rest the day after surgery, wound complications in the immediate postoperative period, blood transfusions, or symptomatic deep vein thrombosis? Between January 2015 and May 2017, a single surgeon performed 156 HTOs, all of which were done using the medial opening wedge technique. We began using intravenous TXA for all HTOs in June 2016. This left us with 89 patients who were treated during a time when no TXA was used and 67 patients who were treated when all patients received TXA. Two patients in the control group had simultaneous TKA in the contralateral leg and one patient in each group had missing data so these patients were excluded, leaving 86 (97%) patients in the control group and 66 (98.5%) in the TXA group available for analysis in this retrospective study. There were no demographic differences between the groups in terms of age, sex, body mass index, and baseline hemoglobin values. Total estimated blood loss was the primary outcome variable, which was calculated using total blood volume and decrease in hemoglobin values. Secondary outcome variables included pain VAS at rest the day after surgery, wound complications in the immediate postoperative period, allogeneic blood transfusions, and occurrence of symptomatic thromboembolic manifestations. The decision on when to transfuse was based on predetermined criteria. An orthopaedic surgeon not involved in patient care collected the patient data from electronic medical records and did chart review. The TXA group had less total blood loss (372 ± 36 mL versus 635 ± 53 mL, mean difference 263 mL [95% confidence interval, 248-278]; p < 0.001). Between groups, differences in VAS pain scores at rest the day after surgery favored the TXA group but were small and unlikely to be clinically important. There were two wound complications in the control group (one hematoma and one superficial wound infection) and none in the TXA group. No patients in either group received a blood transfusion, and no symptomatic thromboembolic events were detected in either group. This study demonstrates that the systemic administration of TXA reduces postoperative blood loss in medial opening wedge HTO; however, insofar as no transfusions were administered to patients even before the routine use of TXA in this series, and no clinically important differences in pain scores were identified, the clinical benefit of routine use of TXA in patients undergoing HTO is uncertain. Our study was too small to make safety-related claims on rare endpoints such as wound complications or thromboembolic events. Larger, and preferably randomized, trials are needed to help define whether it is important to use TXA in this setting. Our data can help inform sample size calculations for such studies. Level III, therapeutic study.

The Results of Medial Horizontal Suture Fixation of Akin Osteotomy in Hallux Valgus

Purpose The purpose of this study was to analyze the clinical results of medial horizontal suture fixation of Akin osteotomy in hallux valgus and present its advantages. Materials and Methods This study was based on 48 cases of 35 patients with Akin osteotomy, who underwent surgery of hallux valgus between December 2014 and July 2015, and with at least 12 months of follow-up. The mean age of patients was 46.9 years (range, 16~71 years). The mean follow-up duration was 15.9 months (range, 12~18 months). Clinical evaluations included pain visual analogue scale (VAS) score, American Orthopaedic Foot and Ankle Society (AOFAS hallux metatarsophalangeal interphalangeal scale) score, and satisfaction score. Weightbearing anteroposterior radiographs were taken to measure the distal articular set angle (DASA) of the hallux. Radiographic bone union at 6 months follow-up was regarded as a success, while a loss of reduction and nonunion was regarded as a failure. Results The mean pre- and postoperative pain VAS scores were 4.27 and 1.67, respectively (p<0.05). The mean AOFAS score improved from 59.7 to 80.5 (p<0.05). The DASA was improved from 8.15 to –2.57 (p<0.05). There was no case of skin irritation, cortical breakage, inflammation from the knot, and infection. All patients showed union without fixation failure. Conclusion The clinical and radiological evaluations in this study demonstrate reliable results without complication. The medial horizontal suture fixation of the Akin osteotomy was effective, and the advantage of this procedure was unnecessity of the material removal, preservation of the joint, and no skin irritation.