Meaningful Improvements In Pain Research Articles

Patient-reported outcomes (PRO) in the GARNET trial in patients (pts) with advanced or recurrent dMMR/MSI-H endometrial cancer (EC) treated with dostarlimab.

e18032 Background: PRO enable direct measurement of the experiences of patients with cancer. Anti-programmed death 1 (PD-1) therapies have shown favorable PRO in lung cancer but a data gap remains in EC. Dostarlimab is an investigational anti-PD-1 monoclonal antibody which has shown promising activity in GARNET in advanced mismatch repair deficient (dMMR) EC pts (with an ORR of 42.9% and a disease control rate of 58.6%), and a low incidence of symptomatic grade ≥3 treatment-related adverse events (anemia [2·9%], colitis [1·9%], and diarrhea [1·9%]). Here, we report on PRO measures collected from pts with dMMR/microsattelite instability high (MSI-H) EC in the single-arm GARNET trial. Methods: Pts with dMMR/MSI-H EC confirmed by local tests, with recurrent or advanced disease that progressed on a platinum regimen were enrolled. Pts received 500 mg Q3W of dostarlimab for 4 cycles, then 1000 mg Q6W until disease progression or discontinuation. PRO assessment was an exploratory endpoint and was measured by the EORTC Quality of Life Questionnaire (QLQ-C30), a validated instrument used to evaluate quality of life, functioning, disease symptoms, and treatment-related side effects. PRO were collected at each dose administration, end of treatment, and follow-up. A mixed-model for repeated measures was used to assess change from baseline, accounting for time and baseline ECOG scores. The threshold to determine clinically meaningful group-level change was ±10 points. Results: PRO data were available for 43 pts. Compliance rates were high at 98%. Relative to baseline, pts reported meaningful improvements in pain, insomnia, and social and emotional functioning over the trial duration. Appetite, nausea, vomiting, constipation, diarrhea, and physical and role functioning were stable over the trial duration. Quality of life and global health status were also maintained. Conclusions: PRO from 43 pts enrolled in the GARNET trial show that disease- and treatment-related symptoms and quality of life are improved or maintained while receiving treatment. These data, along with with the efficacy and safety profile of dostarlimab, strongly support the use of dostarlimab in dMMR/MSI-H advanced EC. Clinical trial information: NCT02715284.

EP25 Impact of sarilumab on unacceptable pain and inflammation control in moderately-to-severely active rheumatoid arthritis (RA) patients in 3 Phase 3 studies

Abstract Background In RA patients, unacceptable pain (UP) may persist despite inflammation control (refractory pain [RP]). Sarilumab is indicated (either with methotrexate or as monotherapy if methotrexate is not tolerated/appropriate) for adults with moderately-to-severely active RA with an inadequate response or intolerance to ≥ 1 conventional synthetic disease-modifying antirheumatics (csDMARD). The recommended dose is 200 mg every 2 weeks (q2w) with dose reduction to 150 mg if required for management of laboratory abnormalities. Three randomised controlled trials (RCTs) of subcutaneous sarilumab 150 or 200 mg q2w vs comparators showed meaningful improvements in pain. This analysis assessed UP and RP in these trials. Methods RCTs evaluated sarilumab 150 and 200 mg q2w vs placebo (+csDMARDs: MOBILITY/NCT01061736 and TARGET/NCT01709578) and sarilumab 200 mg q2w vs adalimumab 40 mg q2w (MONARCH/NCT02332590). Post-hoc analyses calculated odds ratios (ORs) of UP (based on patient acceptable symptom state on a threshold of visual analog scale pain >40 mm [0-100]), RP (UP+C-reactive protein <10 mg/L), and RP-strict (RP + ≤1 swollen joint count [SJC]), and associations between pain and fatigue (FACIT-Fatigue) and disease activity (Health Assessment Questionnaire [HAQ], SJC and tender joint count [TJC]). P values are nominal. Results Across all three trials, sarilumab 150 and 200 mg q2w had lower odds of UP (p < 0.05; ORs 0.39-0.46 vs placebo and 0.54 vs adalimumab). In MOBILITY, sarilumab 150 and 200 mg q2w had lower odds (p < 0.05) of RP vs placebo at Week 24 (ORs 0.60 [0.38,0.93] and 0.57 [0.37,0.87]) and Week 52 (ORs 0.64 [0.37,1.02] and 0.62 [0.37,1.02]), and RP-strict at Week 52 (0.41 [0.19,0.90] and 0.35 [0.16,0.76]). In TARGET, sarilumab 150 mg q2w had lower odds (p < 0.05) of RP-strict at Week 24. Higher pain was associated with worse FACIT-fatigue, HAQ, SJC and TJC scores (all p < 0.001). Conclusion Sarilumab was associated with lower odds of UP or RP vs adalimumab or placebo. Disclosures V. Bykerk: Consultancies; Abbvie, Amgen, Brainstorm Therapeutics, Bristol-Myers Squibb, Genentech, Gilead, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Scipher, Union Chimique Belge. Shareholder/stock ownership; Abbvie, Amgen, Brainstorm Therapeutics, Bristol-Myers Squibb, Genentech, Gilead, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Scipher, Union Chimique Belge. Grants/research support; AbbVie, Amgen, Brainstorm Therapeutics, Bristol-Myers Squibb, Genentech, Gilead, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, Scipher, Union Chimique Belge. W. Wei: Shareholder/stock ownership; Regeneron Pharmaceuticals, Inc. Other; Regeneron Pharmaceuticals, Inc. S. Boklage: Shareholder/stock ownership; Regeneron Pharmaceuticals, Inc. Other; Regeneron Pharmaceuticals, Inc. T. Kimura: Shareholder/stock ownership; Regeneron Pharmaceuticals, Inc. Other; Regeneron Pharmaceuticals, Inc. S. Fiore: Shareholder/stock ownership; Sanofi. Other; Sanofi. G. St John: Shareholder/stock ownership; Regeneron Pharmaceuticals, Inc. Other; Regeneron Pharmaceuticals, Inc.

Duration and Dosage of Opioids After Spine Surgery: Implications on Outcomes at 1 Year.

Longitudinal Cohort Study OBJECTIVE.: The aim of this study was to determine whether duration of postoperative opioids is associated with long-term outcomes, and if initial postoperative opioid dosage is associated with opioid cessation after spine surgery. Preoperative opioid use is associated with poor outcomes, but little evidence exists regarding the implications of opioid dosage and duration after spine surgery. Data from our state's prescription drug database was linked to our prospective clinical spine registry to analyze opioid dispensing and outcomes in elective surgical spine patients between 2010 and 2017. Patients were stratified based on preoperative chronic opioid use and multivariable regression was used to assess associations between duration of postoperative opioids and outcomes at one year, including satisfaction, chronic opioid use, and meaningful improvements in pain, disability, and quality of life. In a secondary aim, a Cox proportional hazards model was used to determine whether initial postoperative opioid dosage was associated with time to opioid cessation. Of 2172 patients included, 35% had preoperative chronic opioid use. In patients without preoperative chronic opioid use, a postoperative opioid duration of 31 to 60 days was associated with chronic opioid use at 1 year (adjusted odds ratio [aOR]: 4.1 [1.7-9.8]) and no meaningful improvement in extremity pain (aOR: 1.8 [1.3-2.6]) or axial pain (aOR: 1.6 [1.1-2.2]); cessation between 61 and 90 days was associated with no meaningful improvement in disability (aOR: 2 [1.3-3]) and dissatisfaction (aOR:1.8 [1-3.1]). In patients with preoperative chronic opioid use, postoperative opioids for ≥90 days was associated with dissatisfaction. Cox regression analyses showed lower initial postoperative opioid dosages were associated with faster opioid cessation in both groups. Our results suggest that a shorter duration of postoperative opioids may result in improved 1-year patient-reported outcomes, and that lower postoperative opioid dosages may lead to faster opioid cessation. 2.

Effect of Normal Saline Injections on Lateral Epicondylitis Symptoms: A Systematic Review and Meta-analysis of Randomized Clinical Trials

Background: Lateral epicondylitis, or tennis elbow, is a painful degenerative disorder that commonly occurs in adults between 40 and 60 years of age. Normal saline (NS) injections have been used as placebo through a large number of randomized controlled trials (RCTs) focused on the treatment of lateral epicondylitis. Purpose: This meta-analysis of RCTs aimed to assess the therapeutic effect of NS injections on lateral epicondylitis symptoms and compare results with established minimal clinically important difference criteria. Study Design: Systematic review and meta-analysis. Methods: MEDLINE, Embase, Web of Science, and Scopus databases were searched for clinical trials reporting pain and joint function with the visual analog scale, Patient-Rated Tennis Elbow Evaluation, and Disabilities of the Arm, Shoulder and Hand in patients with lateral epicondylitis. The meta-analysis was conducted with a random effects model and generic inverse variance method. Heterogeneity was tested with the I2 statistic index. Results: A total of 15 RCTs included in this meta-analysis revealed a significant improvement in pain (mean difference, 3.61 cm [95% CI, 2.29-4.92 cm]; P < .00001; I2 = 88%; visual analog scale) and function (mean difference, 25.65 [95% CI, 13.30-37.99]; P < .0001; I2 = 82%; Patient-Rated Tennis Elbow Evaluation / Disabilities of the Arm, Shoulder and Hand) after NS injection (≥6 months). Conclusion: NS injections yielded a statistically significant and clinically meaningful improvement in pain and functional outcomes in patients with lateral epicondylitis. New research should focus on better methods to diminish the potential confounders that could lead to this effect because NS injections could mask the real effect of an active therapeutic intervention in RCT. Registration: CRD42019127547 (PROSPERO).

Outcomes of prescription opioid dose escalation for chronic pain: results from a prospective cohort study.

The use of long-term opioid therapy for chronic pain remains common, yet data on long-term outcomes, especially after dose escalation, are sparse. This study examined potential benefits and harms associated with prescription opioid dose escalation. Participants from 2 institutions were enrolled in a 2-year prospective cohort study. All participants (n = 517) had a musculoskeletal pain diagnosis and were receiving a stable dose of long-term opioid therapy at baseline. Participants completed self-report measures of pain, disability, depression, and potential adverse effects at baseline and every 6 months for 2 years. We reviewed electronic health record data weekly to identify episodes of prescription opioid dose escalation; participants who had increases in their dose were seen for additional research visits within 1 month of dose escalation. Over 2 years, 19.5% of participants had prescription opioid dose increases. After controlling for covariates, there were no significant changes on any variable after dose escalation. Of those with a dose increase, 3% experienced a clinically meaningful improvement in pain after dose escalation. Participants in the entire sample had small improvements in pain intensity, depressive symptoms, medication-related side effects, and lower risk for prescription opioid misuse during the study period. Sexual functioning worsened over time. There were no significant changes in the full sample on pain disability, sleep functioning, or experiencing a fall. In summary, patients prescribed stable doses of long-term opioid therapy may demonstrate small changes in key pain-related outcomes over time, but prescription opioid dose escalation status is unrelated to clinical outcomes.

Treatment outcomes in group-based cognitive behavioural therapy for chronic pain: An examination of PTSD symptoms.

The relevance of post-traumatic stress disorder (PTSD) symptoms to outcomes of cognitive behavioural therapy (CBT) for chronic pain is unclear. This study examines whether (a) traumatic exposure or the severity of PTSD symptoms at pre-treatment predicts the outcomes (pain intensity/interference), (b) participation in this treatment is associated with reduced PTSD symptoms and (c) any observed changes in PTSD symptoms are mediated by changes in psychological mechanisms that have been shown to be of importance to PTSD and chronic pain. Participants were 159 chronic pain patients who were consecutively admitted for a multidisciplinary, group-based CBT program at the Pain Rehabilitation Unit at Skåne University Hospital. A self-report measure of traumatic exposure and PTSD symptoms was administered before and after treatment, and at a 12-month follow-up, along with measures of depression, anxiety, pain intensity, pain interference, psychological inflexibility, life control and kinesiophobia. Traumatic exposure and PTSD symptom severity did not predict pain intensity or interference at 12-month follow-up. There were no overall significant changes in PTSD symptom severity at post-treatment or follow-up, but 24.6% of the participants showed potential clinically significant change at follow-up. Psychological inflexibility mediated the changes that occurred in PTSD symptoms during treatment. Neither traumatic exposure nor baseline symptoms of PTSD predicted the treatment outcomes examined here. Despite improvements in both comorbid depression and anxiety, participation in this pain-focused CBT program was not associated with improvements in comorbid PTSD. To the extent that changes in PTSD symptoms did occur, these were mediated by changes in psychological inflexibility during treatment. Pain-focused CBT programs yield clinically meaningful improvements in pain and comorbid symptoms of depression and anxiety, but may have little effect on comorbid PTSD. This raises the issue of whether current pain-focused CBT programs can be modified to improve outcomes for comorbid conditions, perhaps by better targeting of psychological flexibility, and/or whether separate treatment of PTSD may be associated with improved pain outcomes.

Lumbar facet distraction and fixation in patients with lumbar spinal stenosis: Long-term clinical outcome and reoperation rates.

Objective:Symptomatic lumbar spinal stenosis (LSS) unresponsive to conservative therapy is commonly treated by surgical decompression. In this study, we compared clinical outcomes after decompressive surgery for LSS in patients implanted with interarticular spacers along with microdecompression (MD) with those receiving only MD.Methods:A retrospective study was analyzed 40 patients (Group A) affected by LSS treated by MD and implant of interarticular spacers comparing the outcome with a homogeneous group of 40 patients with LSS treated with MD alone (Group B). Clinical outcome was evaluated using the Oswestry Disability Index (ODI) and visual analog scale (VAS) scores, as well as Macnab's criteria.Results:At 1-year follow-up, ODI improved in both groups with statistically significant differences as compared to baseline and both Groups (P < 0.05). Statistically significant differences were observed at 3-year follow-up (P < 0.05), without further variation at 5-year follow-up. At 1-year follow-up, VAS for back and leg pain scores was significantly better than that of Group B (P < 0.05). At 3-year follow-up, back and leg pain scores were no longer significantly improved (P > 0.01), resulting almost the same at 5-year follow-up. A comparison of functional outcomes between the groups showed significant improvements in Group A as compared to Group B (P < 0.05). The reoperation rate was 10% in Group A and 30% in Group B. In implanted patients, successful fusion was obtained in 90% of the cases.Conclusions:Interarticular spacers showed significant and clinically meaningful improvements in pain and disability, even in a long follow-up.

Platelet-Rich Plasma Versus Corticosteroid Injections in the Management of Elbow Epicondylitis and Plantar Fasciitis: An Updated Systematic Review and Meta-analysis

Background: Platelet-rich plasma (PRP), as a promising alternative to traditional corticosteroid (CS), is now increasingly used in the treatment of elbow epicondylitis (EE) and plantar fasciitis (PF). To date, however, the synthesis of information on the clinical efficacy of PRP versus CS is limited with divergent conclusions. Purpose: To compare the clinical efficacy of PRP and CS injections in reducing pain and improving function in EE and PF. Study Design: Systematic review and meta-analysis. Methods: Online databases were searched from inception to October 2018 for prospective studies evaluating PRP versus CS injections for EE or PF. Independent reviewers undertook searches, screening, and risk-of-bias appraisals. The primary outcomes of interest were pain and function in both the short term (1-3 months) and the long term (≥6 months). Results: Twenty trials with 1268 participants were included. For EE, PRP provides a statistically and clinically meaningful long-term improvement in pain, with a very large effect size of −1.3 (95% CI, −1.9 to −0.7) when compared with CS, but the evidence level was low. For EE, there was moderate evidence that CS provides a statistically meaningful improvement in pain in the short term, with a medium effect size of 0.56 (95% CI, 0.08-1.03) as compared with PRP; this improvement might not be clinically significant. For PF, there was low evidence that PRP provides a statistically and clinically meaningful long-term improvement in function (American Orthopedic Foot & Ankle Society score), with a very large effect size of 1.94 (95% CI, 0.61-3.28). There were no significant differences between the groups in improvement in function in EE and pain and short-term function in PF, but the quality of the evidence was low. Conclusion: The use of PRP yields statistically and clinically better improvement in long-term pain than does CS in the treatment of EE. The use of PRP yields statistically and clinically better long-term functional improvement than that of CS in the treatment of PF.

Matching Patient Expectations after Ankle Fusion Based on Patient Reported Outcome Measures

Category:Ankle ArthritisIntroduction/Purpose:Much research on outcomes after ankle fusion focuses on gait changes, progression of adjacent joint arthritis, and other clinical measures, but little has been reported on the patient’s perspective. The purpose of this study was to determine the change in physical function and pain after undergoing ankle arthrodesis as determined by patient reported outcomes (PROs).Methods:This was a retrospective review of prospectively collected patient reported outcomes data in 88 consecutive ankle arthrodesis procedures performed from May 2015 to March 2018. Patient reported physical function (PF) and pain interference (PI) were measured as part of the routine care via the PROMIS computerized adaptive test at 6 months and 1 year post- operatively. Descriptive data and Spearman correlations were determined for PF and pain at 6 months and 1 year.Results:The mean pre-operative PF T-score was 37, less than the pre-determined threshold value of 42, indicating that this cohort was impaired physically and would respond positively to surgical intervention. The mean pre-operative PI T-score was 63 indicating moderate to high baseline pain and greater than the threshold value of 60, indicating that this patient cohort would have decreased pain after surgical intervention. The meaningful clinically important difference (MCID) was achieved for PI at 6 months and 1 year post-operatively (T-score of 4 and 6, respectively). At 6 months and 1 year, there was a moderate inverse correlation between PF and PI (r=-0.49, r=-0.61 respectively) suggesting less pain and more function. Demographic data, mean follow-up time, and mean PROMIS T-scores are seen in Table 1.Conclusion:The results of this study indicate that patients can expect to have a clinically meaningful improvement in pain after undergoing ankle fusion. Although patients do improve marginally in physical function, it is most likely the improvement in pain that is the greatest benefit to these patients at one year after ankle arthrodesis. This information is important to share with patients to align patient expectations with surgical results.

Evidence for miniscalpel-needle/needle knife in the management of chronic pain related conditions

Objective:The aim of this systematic review with meta-analysis is to determine the effect of miniscalpel-needle/needle-knife in treatment of chronic pain symptoms.Methods:The following electronic databases will be searched by 2 independent reviewers: PubMed, Cochrane Library, EMBASE, Springer, China National Knowledge Infrastructure (CNKI), Wanfang, and Chinese Biomedical Literature Database (CBM). All randomized controlled trials on miniscalpel-needle/need-knife for chronic pain published in electronic databases from inception to August 1, 2019 with language restricted in Chinses and English will be included in the study.Methodologic quality is assessed by 2 blinded reviewers independently screen and score the articles using the Physiotherapy Evidence Database (PEDro) scale and the Cochrane Collaboration risk of bias tool. A meta-analysis was performed when there is sufficient clinical homogeneity in at least 2 studies. The Grading of Recommendations Assessment, Development and Evaluation approach is used to rate the body of evidence in each meta-analysis. When the quantitive evaluation is not available, a qualitative description of the results of single study is provided.Results:A high-quality synthesis of current evidence of miniscapel-needle/needle-knife treating chronic pain will be illustrated using subjective reports and objective measures of performance. The primary outcomes consisted of pain intensity improvement rate clinically meaningful improvements in pain and disability are also noted. Secondary outcomes involve the short form of McGill Pain Questionnaire score (SF-MPQ) and the side effects.Conclusion:This protocol will present the evidence of whether miniscalpel-needle/needle-knife is an effective intervention for chronic pain.PROSPERO registration number:CRD42019129076

Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08)

ContextAlthough opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails. ObjectivesWe investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy. MethodsA multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]–Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases. ResultsSeventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002). ConclusionAdding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine.

Preoperative Opioids and 1-year Patient-reported Outcomes After Spine Surgery.

Longitudinal Cohort Study. Determine 1-year patient-reported outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosages in patients undergoing elective spine surgery. Back pain is the most disabling condition worldwide and over half of patients presenting for spine surgery report using opioids. Preoperative dosage has been correlated with poor outcomes, but published studies have not assessed the relationship of both preoperative chronic opioids and opioid dosage with patient-reported outcomes. For patients undergoing elective spine surgery between 2010 and 2017, our prospective institutional spine registry data was linked to opioid prescription data collected from our state's Prescription Drug Monitoring Program to analyze outcomes associated with preoperative chronic opioid therapy and high-preoperative opioid dosage, while adjusting for confounders through multivariable regression analyses. Outcomes included 1-year meaningful improvements in pain, function, and quality of life. Additional outcomes included 1-year satisfaction, return to work, 90-day complications, and postoperative chronic opioid use. Of 2128 patients included, preoperative chronic opioid therapy was identified in 21% and was associated with significantly higher odds (adjusted odds ratio [95% confidence interval]) of not achieving meaningful improvements at 1-year in extremity pain (aOR:1.5 [1.2-2]), axial pain (aOR:1.7 [1.4-2.2]), function (aOR:1.7 [1.4-2.2]), and quality of life (aOR:1.4 [1.2-1.9]); dissatisfaction (aOR:1.7 [1.3-2.2]); 90-day complications (aOR:2.9 [1.7-4.9]); and postoperative chronic opioid use (aOR:15 [11.4-19.7]). High-preoperative opioid dosage was only associated with postoperative chronic opioid use (aOR:4.9 [3-7.9]). Patients treated with chronic opioids prior to spine surgery are significantly less likely to achieve meaningful improvements at 1-year in pain, function, and quality of life; and less likely to be satisfied at 1-year with higher odds of 90-day complications, regardless of dosage. Both preoperative chronic opioid therapy and high-preoperative dosage are independently associated with postoperative chronic opioid use. 2.

Clinical efficacy of a simplified approach to managing chronic temporomandibular disorders: evidence from a 1-year case series

Chronic temporomandibular disorder (cTMD) produces orofacial pain and limited jaw function and impacts on quality of life. A clinical case series of patients referred to a hospital specialist service is described here. In a 1-year consecutive case series of 162 patients with cTMDs, each patient had been managed with self-awareness and jaw exercises, as well as oral appliances. Pain severity and chewing function were scored by using a visual analogue scale (VAS), and quality of life was assessed by using the Oral Health Impact Profile-Temporomandibular Dysfunction (OHIP-TMD). Females comprised 87% (average age 49 years). Treatment time averaged 20.8 months, and the average pain duration was 2.8 years. The mean VAS pain score fell from 6.9 (standard deviation [SD] 1.6) to 2.0 (SD 1.9) after treatment, giving a "large" effect size of 3.1. Chewing difficulty improvement also showed a "large" effect size (2.5). For the 33 patients for whom longitudinal OHIP-TMD data were available, the mean pretreatment and posttreatment scores of 51.2 (SD 20.9) and 26.2 (SD 17.7) showed a "large" effect size of 1.2. A simple noninvasive protocol for managing cTMD with self-help, exercises, and oral devices resulted in clinically and statistically meaningful improvements in pain, function, and quality of life.

STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial

BackgroundPhysical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.Methods / DesignStep-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.DiscussionSTEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.Trial RegistrationClinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Osteochondral Allograft Transplantation of the Femoral Condyle Utilizing a Thin Plug Graft Technique

Background: Previous studies showed clinical benefit and durable results of osteochondral allograft (OCA) transplantation for the treatment of femoral condyle lesions. However, the majority of these studies are difficult to interpret owing to the mixed results of different techniques and anatomic locations. Purpose: To evaluate the outcome of OCA transplantation with thin plug grafts for treatment of isolated femoral condyle osteochondral lesions. Study Design: Case series; Level of evidence, 4. Methods: This study included 187 patients (200 knees) who underwent OCA transplantation for isolated osteochondral lesions on the femoral condyle between 1999 and 2014. For all cases, a thin plug technique was used with commercially available surgical instruments and the minimum amount of bone necessary for fixation. Evaluation included International Knee Documentation Committee score, Knee injury and Osteoarthritis Outcome Score, and patient satisfaction. Frequency and type of further surgery were assessed. Failure of the allograft was defined as further surgery involving removal of the allograft. Results: Mean follow-up was 6.7 years (range, 1.9-16.5 years). The mean age of patients at the time of surgery was 31 years, and 63% were male. The medial femoral condyle was affected in 69% of knees. A single thin plug graft was used in 145 knees (72.5%), and 2 grafts were used in 55 knees (27.5%). Mean allograft area was 6.3 cm2, and graft thickness was 6.5 mm (cartilage and bone combined). Further surgery was required for 52 knees (26%), of which 16 (8% of entire cohort) were defined as allograft failures (4 OCA revisions, 1 arthrosurface, 6 unicompartmental knee arthroplasties, and 5 total knee arthroplasties). Median time to failure was 4.9 years. Survivorship of the allograft was 95.6% at 5 years and 91.2% at 10 years. Among patients with grafts remaining in situ at latest follow-up, clinically meaningful improvement in pain, function, and quality of life was reported. Satisfaction was reported by 89% of patients. Conclusion: OCA transplantation with a thin plug graft technique is a valuable procedure for the treatment of femoral condyle osteochondral lesions, resulting in significant improvement in clinical scores, high patient satisfaction, and low reoperation and clinical failure rates.

Exercises for Older Adults With Knee and Hip Pain

Half of all older adults report knee and/or hip pain. Obesity and sedentary lifestyle contribute to the incidence and prevalence of painful knee and hip conditions. Weight loss should be a priority in overweight or obese patients. Improving joint function over time requires a balance of rest and usage. Practitioners should assess joint disorders and recommend exercises for reducing knee and hip pain with patients when appropriate. Instruction should include a combination of 1) stretching and flexibility, 2) strength training, and 3) endurance conditioning exercises. Even small improvements in exercise can make meaningful improvements in pain, movement, endurance, and quality of life.

Smartphone app in self-management of chronic low back pain: a randomized controlled trial.

Mobile health (mHealth) is emerging as the most convenient way to deliver rehabilitation services remotely, and collect outcomes in real time, thus contributing to disease management by transferring care from hospital to home. It facilitates accessibility to healthcare, enhances patients' understanding of their condition, and their willingness to engage in self-management, giving way to high-quality care to the satisfaction of both patients and healthcare professionals. The purpose of this study was to examine the effect of using a smartphone app (called Snapcare) on pain and function in patients suffering from chronic low back pain. Ninety-three patients with chronic low back pain were recruited and randomly allocated to either the Conventional group (n = 48) receiving a written prescription from the Physician, containing a list of prescribed medicines and dosages, and stating the recommended level of physical activity (including home exercises) or the App group (n = 45) receiving Snapcare, in addition to the written prescription. Pain and disability were assessed at baseline and after 12weeks of treatment. Both the groups showed significant improvement in pain and disability (p < 0.05). The App group showed a significantly greater decline in disability (p < 0.001). Health applications are promising tools for improving outcomes in patients suffering from various chronic conditions. Snapcare facilitated increase in physical activity and brought about clinically meaningful improvements in pain and disability in patients with chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.

Acupuncture for Cancer Pain and Symptom Management in a Palliative Medicine Clinic.

Studies suggest acupuncture improves cancer-related symptoms; however, it is unclear whether patient characteristics predict pain response. This study determined acupuncture's effect on cancer-related pain and identified variables associated with pain response. A retrospective chart review included adult patients with cancer referred to palliative medicine and received acupuncture for pain management. Paired t tests compared differences in pain scores from pre- to postacupuncture. Clinically meaningful pain improvement was defined as ≥2-point reduction in pain score. Logistic regression was used to evaluate associations between patient characteristics and pain improvement. One hundred seventy acupuncture treatments from 68 individual patients were studied. Significant reductions in mean pain scores were observed after the first treatment (-1.9 ± 1.8; P < .001) and across all treatments (-1.7 ± 1.9; P < .001). Multivariable analysis demonstrated clinically meaningful pain improvement with higher baseline pain scores (odds ratio [OR]: 1.79, 95% confidence interval [CI]: 1.44-2.22; P < .001) and stage III/IV disease (OR: 3.23, 95% CI: 1.11-9.40; P < .001). There were significant improvements in anxiety, depression, drowsiness, dyspnea, fatigue, nausea, and well-being after the first treatment and across all treatments ( P < .001). Acupuncture improved cancer-related pain and other symptoms. Those with higher baseline pain scores and advanced disease were more likely to achieve significant pain reduction. Improved depression and fatigue were closely related to pain reduction. Further studies are needed to confirm pain response variables, establish durability, and develop a personalized approach to acupuncture.

Early stage periarticular injection during total knee arthroplasty may provide a better postoperative pain relief than late-stage periarticular injection: a randomized-controlled trial

PurposeThis study was performed to determine whether periarticular injection performed in the early stage of total knee arthroplasty (TKA) could provide a better postoperative pain relief than periarticular injection performed in the late stage of TKA. The hypothesis was based on the concept that analgesic intervention before the onset of noxious stimuli would be associated with less postoperative pain.MethodsA total of 105 participants were randomly assigned to receive superficial injection just prior to arthrotomy (early stage periarticular injection group) or superficial injection after implanting the prosthesis (late-stage periarticular injection group) in patients undergoing unilateral TKA with 1:1 treatment allocation. In both groups, deep injection was performed according to the same schedule (just prior to implanting prosthesis). The solution consisted of 300 mg of ropivacaine, 8 mg of morphine, 40 mg of methylprednisolone, 50 mg of ketoprofen, and 0.3 mg of epinephrine mixed with normal saline to a final volume of 60 mL. All surgeries were managed under general anesthesia without any regional blocks. Registry-specified primary outcome was postoperative pain score at rest measured at the recovery room using a 100-mm visual analog scale (VAS). The VAS score was compared between two groups and assessed to reach the reported threshold values for the minimal clinically important difference (MCID) of 10 mm for the postoperative VAS score.ResultsThe VAS score at the recovery room was significantly lower in the early stage periarticular injection group than the late-stage periarticular injection group (23 ± 25 mm versus 39 ± 34 mm, respectively; 95% confidence interval 4–28 mm; p = 0.0078). The mean difference in the primary outcome fulfilled the MCID value.ConclusionsBringing forward the timing of periarticular injection may provide significant and clinically meaningful improvement in pain following TKA under general anesthesia.Level of evidenceI.

Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P50. A randomized prospective comparative trial of water-cooled versus traditional radiofrequency ablation of the median branch nerve in the treatment of zygapophyseal joint pain: six-month outcomes

BACKGROUND CONTEXT No study has compared the effectiveness of water-cooled radiofrequency ablation (WC-RFA) and traditional RFA (T-RFA) of the medial branch nerves (MBNs) for lumbar zygapophyseal joint (Z-joint) pain. PURPOSE Evaluate six-month pain, functional, psychometric, and medication usage outcomes of MBN WC-RFA versus T-RFA for lumbar Z-joint pain. STUDY DESIGN/SETTING Randomized comparative trial at an urban, tertiary, academic spine or pain center. PATIENT SAMPLE Individuals with Z-joint pain diagnosed by clinical evaluation and positive diagnostic MBN blocks (>50% relief) were randomized to WC-RFA or T-RFA. OUTCOME MEASURES The primary outcome was the proportion of “responders” (≥50% NRS reduction) at 6-months. Secondary outcomes included the NRS, ODI, Patient Anxiety Symptom Scale (PASS-20), McGill Pain Inventory (MPI), Center for Epidemiologic Studies Depression scale (CESD-10), daily morphine equivalents (DME), and Patient Global Impression of Change (PGIC). METHODS Six-month clinical outcomes were compared in the the group that was randomized to WC-RFA and the group that was randomized to T-RFA. Data were analyzed by descriptive statistics, chi-square tests, one-sample t-tests, independent t-tests, and Mann-Whitney-Wilcoxon tests RESULTS Forty participants (mean age=55.9, 24 females, mean BMI 30.2 kg/m2) underwent MBN WC-RFA (n=21) or T-RFA (n=19). There were no differences in demographic variables (p>.05). A ≥50% NRS reduction was observed in 52% (95% CI 31%–74%) and 47% (95% CI 26%–71%) of participants undergoing WC-RFA and T-RFA, respectively, at 6 months (p=.75). A ≥15-point or ≥30% reduction 6 months was observed in 62% (95% CI 39%–80%) and 42% (95% CI 22%–66%) of participants in the WC-RFA and T-RFA groups, respectively (p=.21). Significant reductions in mean NRS and ODI scores were observed in both groups: WC-RFA (NRS 7.4–3.6; ODI 29–18) and T-RFA (NRS 7.1–4.2; ODI 26–19) (NRS p 0.05). CONCLUSIONS Approximately half of participants reported clinically meaningful improvements in pain and function with MBN WC-RFA and T-RFA at 6 months, with no intergroup differences observed. These results are representative of a selection protocol with a high false-positive rate; use of dual comparative MBN blocks for patient selection would likely result in a higher success rate regardless of RFA modality.